A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Pfizer

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2, 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1
A P H A S E 4 , O P E N -L A B E L, SI N G L E -A R M, M U L TI C E N T E R S T U D Y O F 
I N O T U Z U M A B O Z O G A MI CIN I N C HI N E S E A D U L T P A TI E N T S WI T H 
R E L A P S E D O R R E F R A C T O R Y C D 2 2 -P O SI TI V E A C U T E L Y M P H O B L A S TI C
L E U K E MI A ( A L L)
St u d y I nter ve nti o n N u m ber:
P F -0 5 2 0 8 7 7 3
St u d y I nter ve nti o n N a me:
I n ot uz u ma b Oz o ga mici n
U nite d St ates ( U S) I n vesti g ati o n al Ne w 
Dr u g (I N D) N u m ber:
N A
E ur o pe a n Cli nic al Tri als D at a b ase 
( E u dr a C T) N u m ber:
N A
Cli nic al Tri als. g o v I D:
N C T 0 5 6 8 7 0 3 2
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
N A
Pr ot oc ol N u m ber:
B 1 9 3 1 0 3 4
P h ase:
P hase 4
Brief Title: A P hase 4 ,o pe n -la bel, si n gle-ar m, m ultice nter st u d y i n C hi nese patie nts 
wit h rela pse d or refract or y C D 2 2 -p ositi ve B -cell ac ute l ym p h o blastic le u ke mia ( A L L)
T his d oc u me nt a n d acc o m pa n yi n g materials c o ntai n c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer.  E xce pt as 
ot her wise a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t hese d oc u me nts, y o u a gree t o h ol d t his 
i nf or mati o n i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w ) or 
use it f or u na ut h orize d p ur p oses.  I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer 
m ust be pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2
D oc u me nt Hist or y
D oc u me nt 
Versi o n D ate
A me n d me nt 2
1 5 Ma y
2 0 2 3
A me n d me nt 1
0 3 Marc h 2 0 2 2
Ori gi nal pr ot oc ol
0 2 Dece m ber 2 0 1 9
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y pr ot oc ol a d mi nistrati ve c ha n ge 
letter(s).
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
A m e n d me nt 2 (1 5 M a y
2 0 2 3)
O ver all R ati o n ale f or t he A me n d me nt: A d d e d t he a p pe n di x f or alter nati ve meas ures 
d uri n g p u blic e mer ge ncies t o facilitate c o m plia nce wit h nati o nal C O VI D-1 9 meas ures i n 
C hi na .
Secti o n # a n d 
N a me
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o n -s u bst a nti al
T itle pa ge
C ha n ge t he U S I N D 
n u m ber t o N A a n d 
a d de d N C T n u m ber
U S I N D n u m ber is n ot 
a p plica ble.
N o n -s u bsta ntial
Sec ti o ns 1. 1 a n d 
4. 1
A d d t he defi niti o n of 
sal va ge t hera py.
Clarif y  t he tar gete d 
patie nt p o p ulati o n.
N o n -s u bsta ntial
S ecti o ns 1. 1 a n d 
4. 1
A d d t he descri pti o n t o 
li mit e nr olli n g P h + 
A L L patie nts
Kee p t his P A C st u d y ’s 
p o p ulati o n a n d pri or 
re gi me n c o nsiste nt wit h 
B 1 9 3 1 0 2 2 P hase 3 
st u d y, i n w hic h t he P h + 
perce nta ge al s o 
re prese nts cli nical 
practice.
N o n -s u bsta ntial
Sec ti o ns 1. 1, 
4. 1 , 8. 3. 5, a n d 
9. 5. 2
A d d H y ’s la w cases f or 
H E A C
H E A C will als o re vie w 
H y ’s la w cases.
N o n -s u bsta ntial
Sec ti o ns 1. 1
H 0: C R/ C Ri rate per 
i n vesti gat or’s 
assess me nt sh o ul d be 
“ ≤3 7 %” i nstea d of 
“≥3 7 %”.
C orrect t he t yp o
N o n -s u bsta ntial
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3
Secti o n # a n d 
N a me
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o n -s u bst a nti al
Secti o n 1. 3
A d d descri pti o n of 
la b orat or y assess me nt 
wi n d o w
Clarif y  visit wi n d o w of 
la b orat or y assess me nt
N o n -s u bsta ntial
Secti o n 1. 3
A d d e nr oll me nt 
pr ocess
C o nsiste nt wit h practice
N o n -s u bsta ntial
Secti o n 1. 3  
A d d t he n ote “ or C T b y 
cli nical re q uest ” t o 
C hest X -ra y
C o nsiste nt wit h practice
N o n -s u bsta ntial
S ecti o n 1. 3 
f o ot n otes 3- 7, 9, 
1 4
U p date t he w or di n g 
acc or di n gl y
C o nsiste nt wit h practice
N o n -s u bsta ntial
S ecti o n 2. 2. 1
A d d a p pr o val c o u ntr y
I n ot uz u ma b oz o ga mici n 
was a p pr o ve d i n C hi na
N o n -s u bsta ntial
S ecti o n 5. 1 
I ncl usi o n 2
Re m o ve M 2 or M 3 
marr o w
C o nsiste nt wit h practice
N o n -s u bsta ntial
Secti o n 8. 4. 1  
D eleti o n of t he 
“ Me dical occ urre nces 
t hat … …, n ot t he A E 
secti o n”.
T o be c o nsiste nt wit h 
c o nte xt.
N o n -s u bsta ntial
S ecti o ns 1. 1, 6, 
7. 1, 7. 2, 8, 1 0. 1, 
1 0. 2, 1 0. 3, 1 0. 4, 
1 0. 5, 1 0. 6 , 
1 0. 1 2, 1 0. 1 3
U p date t he w or di n g 
acc or di n gl y
T o ali g n wit h Pfizer’s 
pr ot oc ol te m plate
N o n -s u bsta ntial
T a ble 8
F or matti n g
C orrect t he f or matti n g 
err ors
N o n -s u bsta ntial
S ecti o n 1. 3 a n d 
Secti o n 8. 8 
( P A C L date d 3 0 
A u g 2 0 2 2)
D eleti o n of “A 
peri p heral bl o o d 
sa m ple m ust be 
pr o vi de d if a patie nt 
has a n i na de q uate 
as pirate at scree ni n g.”
Peri p heral bl o o d sa m ple 
will n ot be re q uire d b y 
ce ntral la b orat or y.
N o n -s u bsta ntial
A p pe n di x 1 1 
( P A C L date d 3 0 
A u g 2 0 2 2)
A d de d A p pe n di x 1 1 
Alter nati ve Meas ures 
D uri n g P u blic 
E mer ge ncies
Ma ke s ure t he st u d y  
tea m will a p pr oac h 
q uesti o ns fr o m st u d y  
sites d ue t o t he 
N o n -s u bsta ntial
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4
Secti o n # a n d 
N a me
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o n -s u bst a nti al
C O VI D -1 9 pa n de mic i n 
a c o nsiste nt ma n ner.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5
T A B L E O F C O N T E N T S
LI S T O F T A B L E S ...................................................................................................................1 0
LI S T O F FI G U R E S .................................................................................................................1 0
1. P R O T O C O L  S U M M A R Y...................................................................................................1 1
1. 1. S y n o psis ..................................................................................................................1 1
1. 2. Sc he ma ....................................................................................................................1 9
1. 3. Sc he d ule of Acti vities ( S o A) ...................................................................................2 0
2. I N T R O D U C TI O N ...............................................................................................................2 7
2. 1. St u d y  Rati o nale.......................................................................................................2 7
2. 2. Bac k gr o u n d .............................................................................................................2 7
2. 2. 1. I n ot uz u ma b Oz o ga mici n .............................................................................2 8
2. 2. 2. Cli nical O ver vie w .......................................................................................2 9
2. 2. 2. 1. P hase 3 St u d y  B 1 9 3 1 0 2 2...........................................................2 9
2. 2. 2. 2. P hase 1/ 2 St u d y  B 1 9 3 1 0 1 0 .......................................................3 5
2. 3. Be nefit/ Ris k Assess me nt................................ .........................................................3 6
3. O BJ E C TI V E S, E S TI M A N D S, A N D E N D P OI N T S ...........................................................3 7
4. S T U D Y D E SI G N .................................................................................................................3 8
4. 1. O verall Desi g n .........................................................................................................3 8
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n.....................................................................3 9
4. 3. J ustificati o n f or D ose ..............................................................................................4 1
4. 4. E n d of St u d y  Defi niti o n ..........................................................................................4 1
5. S T U D Y P O P U L A T I ON................................ ......................................................................4 2
5. 1. I ncl usi o n Criteria .....................................................................................................4 2
5. 2. E xcl usi o n Criteria ....................................................................................................4 3
5. 3. L ifest yle C o nsi derati o ns..........................................................................................4 6
5. 3. 1. C o ntrace pti o n ..............................................................................................4 6
5. 4. Scree n Fail ures ........................................................................................................4 6
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y .................................4 6
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................4 7
6. 1. 1. A d mi nistrati o n ............................................................................................4 7
6. 2. Pre parati o n/ Ha n dli n g/ St ora ge/ Acc o u nta bilit y ........................................................4 8
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................4 9
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ...........................................................................5 0
6. 4. Bli n di n g................................ ...................................................................................5 0
6. 5. St u d y  I nter ve nti o n C o m plia nce...............................................................................5 0
6. 6. D ose M o dificati o n ...................................................................................................5 0
6. 6. 1. Rec o m me n de d D ose M o dificati o ns ............................................................5 0
6. 6. 2. D ose Re d ucti o ns .........................................................................................5 1
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ......................5 1
6. 8. Treat me nt of O ver d ose................................ ............................................................5 1
6. 9. Pri or a n d C o nc o mita nt T hera p y.............................................................................. 5 2
6. 9. 1. C o nc o mita nt Me dicati o ns................................ ...........................................5 2
6. 9. 2. Per mitte d C o nc o mita nt Me dicati o ns.......................................................... 5 2
6. 9. 3. Pr o hi bite d C o nc o mita nt Me dicati o ns......................................................... 5 3
6. 9. 4. Disc o ura ge d C o nc o mita nt Me dicati o ns ......................................................5 3
6. 9. 5. Resc ue Me dici ne .........................................................................................5 3
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L ...........................................................................5 3
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n ....................................................................5 3
7. 1. 1. Te m p orar y  Disc o nti n uati o n........................................................................5 5
7. 1. 1. 1. Re d osi n g Criteria a n d D ose Dela y s .......................................... 5 5
7. 2. Partici pa nt Disc o nti n uati o n/ Wit h dra wal Fr o m t he St u d y .......................................5 6
7. 2. 1. Wit h dra wal of C o nse nt:.............................................................................. 5 7
7. 3. L ost t o F oll o w - u p....................................................................................................5 7
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ...............................................................5 8
8. 1. A d mi nistrati ve Pr oce d ures ......................................................................................5 8
8. 2. Efficac y  Assess me nts..............................................................................................5 8
8. 3. Safet y Assess me nts .................................................................................................6 0
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................6 0
8. 3. 2. Vital Si g ns ..................................................................................................6 0
8. 3. 3. Electr ocar di o gra ms..................................................................................... 6 0
8. 3. 4. Cli nical Safet y  La b orat or y Assess me nts....................................................6 1
8. 3. 5. He patic E ve nts A dj u dicati o n C o m mitee ....................................................6 1
8. 3. 6. Pre g na nc y  Testi n g ......................................................................................6 1
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g ..................6 2
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n.......6 2
8. 4. 1. 1. Re p orti n g S A E s t o Pfizer Safet y ...............................................6 3
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F................... 6 3
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es ..........................................................6 4
8. 4. 3. F oll o w -u p of A Es a n d S A Es .......................................................................6 4
8. 4. 4. Re g ulat or y Re p orti n g Re q uire me nts f or S A Es ...........................................6 4
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y  or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure .....................................................6 5
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ......................................................6 5
8. 4. 5. 2. E x p os ure D u ri n g Breastfee di n g ................................................6 6
8. 4. 5. 3. Occ u pati o nal E x p os ure .............................................................6 7
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................6 7
8. 4. 7. Disease Relate d E ve nts a n d/ or Disease Relate d O utc o mes N ot 
Q ualif y i n g as S A Es..........................................................................................6 7
8. 4. 8. A d verse E ve nts of S pecial I nterest .............................................................6 8
8. 4. 8. 1. Lac k of Efficac y ........................................................................6 9
8. 4. 8. 2. P ote ntial V O D/ S O S Cases................................ ........................6 9
8. 4. 9. Me dical De vice Deficie ncies ......................................................................7 1
8. 4. 1 0. Me dicati o n Err ors .....................................................................................7 1
8. 5. P har mac o ki netics ....................................................................................................7 2
8. 6. Ge netics ...................................................................................................................7 3
8. 6. 1. S pecifie d Ge netics ......................................................................................7 3
8. 7. Bi o mar kers ..............................................................................................................7 3
8. 8. I m m u n o ge nicit y Assess me nts .................................................................................7 4
8. 8. 1. A nal y sis of A nti-I n ot uz u ma b Oz o ga mici n A nti b o dies a n d 
Ne utralizi n g A nti -I n ot uz u ma b Oz o ga mici n Anti b o dies ..................................7 4
8. 9. Healt h Ec o n o mics ...................................................................................................7 4
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 7 4
9. 1. Esti ma n ds a n d Statistical H y p ot heses .....................................................................7 4
9. 1. 1. Pri mar y  Esti ma n ds......................................................................................7 5
9. 2. Sa m ple Size Deter mi nati o n .....................................................................................7 5
9. 3. P o p ulati o ns f or A nal ysis .........................................................................................7 5
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8
9. 4. Statistical A nal y ses .................................................................................................7 6
9. 4. 1. Efficac y  A nalys es .......................................................................................7 7
9. 4. 2. Safet y A nal ys es ..........................................................................................7 9
9. 4. 3. Ot her A nal ys es ............................................................................................8 0
9. 4. 3. 1. P har mac o ki netics A nal y sis .......................................................8 0
9. 4. 3. 2. P o p ulati o n P har mac o ki netic ( P K) A nal ys is M o deli n g .............8 0
9. 4. 3. 3. I m m u n o ge nicit y A nal y sis .........................................................8 0
9. 5. I nteri m A nalys es .....................................................................................................8 0
9. 5. 1. Data M o nit ori n g C o m mittee .......................................................................8 0
9. 5. 2. He patic E ve nts A dj u dicati o n C o m mitee ( H E A C)......................................8 0
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S................................ ..........................................................................8 1
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns...............8 1
1 0. 1. 1. Re g ulat or y a n d Et hical C o nsi derati o ns ....................................................8 1
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P .........................................................................8 1
1 0. 1. 2. Fi na ncial Discl os ure .................................................................................8 2
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ........................................................................8 2
1 0. 1. 4. Data Pr otecti o n .........................................................................................8 3
1 0. 1. 5. C o m mittees Str uct ure ...............................................................................8 3
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ...................................................8 3
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ......................................................8 4
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................8 6
1 0. 1. 8. S o urce D oc u me nts ....................................................................................8 7
1 0. 1. 9. St u d y  a n d Site Cl os ure..............................................................................8 7
1 0. 1. 1 0. P u blicati o n P olic y ...................................................................................8 8
1 0. 1. 1 1. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual..............................................8 9
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Tests.................................................................9 0
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -u p, a n d Re p orti n g ......................................................................9 2
1 0. 3. 1. Defi niti o n of A E .......................................................................................9 2
1 0. 3 . 2. Defi niti o n of S A E.....................................................................................9 3
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w- u p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d............................................................................9 5
1 0. 3. 4. Re p orti n g of S A Es.................................................................................... 9 8
1 0. 4. A p pe n di x 4: C o ntrace pti ve G ui da nce a n d C ollecti o n of Pre g na nc y  
I nf or mati o n ................................................................................................................9 9
1 0. 4. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria.................................... 9 9
1 0. 4. 2. Fe male Par tici pa nt Re pr o d ucti ve I ncl usi o n Criteria.................................9 9
1 0. 4. 3. W o ma n of C hil d beari n g P ote ntial a n d N o n -C hil d beari n g P ote ntial ......1 0 0
1 0. 4. 4. C o ntrace pti o n Met h o ds ...........................................................................1 0 1
1 0. 5. A p pe n di x 5 : Li ver Safet y: S u g geste d Acti o ns a n d F oll o w-u p Assess me nts ......1 0 3
1 0. 6. A p pe n di x 6 : E C G Fi n di n gs of P ote ntial Cli nical C o ncer n .................................1 0 5
1 0. 7. A p pe n di x 7. O utc o me Defi niti o ns ................................ ......................................1 0 7
1 0. 8. A p pe n di x 8: Li st of Dr u gs K n o w n t o Pre dis p ose t o T orsa de de P oi ntes ............1 0 9
1 0. 9. A p pe n di x 9. Easter n C o o perati ve O nc ol o g y  Gr o u p ( E C O G) Perf or ma nce 
Stat us .......................................................................................................................1 1 0
1 0. 1 0. A p pe n di x 1 0. Rec o m me n dati o n f or Patie nts Pr ocee di n g t o Tra ns pla nt a n d 
P ote ntial V O D Cases ...............................................................................................1 1 1
1 0. 1 1. A p pe n di x 1 1. Alter nati ve Meas ures D uri n g P u blic E mer ge ncies .....................1 1 2
1 0. 1 1. 1. Eli gi bilit y ..............................................................................................1 1 2
1 0. 1 1. 2. Tele healt h Visits ...................................................................................1 1 2
1 0. 1 1. 3. Alter nati ve Facilities f or Safet y Assess me nts ......................................1 1 2
1 0. 1 1. 3. 1. La b orat or y  Testi n g..............................................................1 1 2
1 0. 1 1. 3. 2. I ma gi n g ................................................................................1 1 3
1 0. 1 1. 3. 3. Electr ocar di o gra ms................................ ..............................1 1 3
1 0. 1 1. 4. S t u d y Inter ve nti o n ................................................................................1 1 3
1 0. 1 1. 5. H o me Healt h Visits ...............................................................................1 1 4
1 0. 1 1. 6. A d verse E ve nts a n d Seri o us A d verse E ve nts....................................... 1 1 4
1 0. 1 1. 7. C O VI D -1 9 Vacci nes .............................................................................1 1 4
1 0. 1 1. 8. C O VI D -1 9 I nfecti o n .............................................................................1 1 4
1 0. 1 2. A p pe n di x 1 2. Ki d ne y  Safety:  M o nit ori n g G ui deli nes.......................................1 1 6
1 0. 1 2. 1. La b orat or y  Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y  Inj ur y ............................................................................1 1 6
1 0. 1 2. 2. A ge -S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns...........1 1 6
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0
1 0. 1 2. 2. 1. A d ults ( 1 8 Years a n d A b o ve) — 2 0 2 1 C K D - E PI 
E q uati o ns................................ .........................................................1 1 6
1 0. 1 2. 3. A d verse E ve nt Gra di n g f or Ki d ne y  Safet y La b orat or y 
A b n or malities .................................................................................................1 1 6
1 0. 1 3. A p pe n di x 1 3. Pr ot oc ol A me n d me nt Hist or y .....................................................1 1 7
1 0. 1 4. A p pe n di x 1 4: A b bre viati o ns .............................................................................1 1 8
1 1. R E F E R E N C E S ................................................................................................................1 2 3
LI S T O F T A B L E S
Ta ble 1.
Sc he d ule of Acti vities ...............................................................................2 0
Ta ble 2.
L o n g Ter m F oll o w -U p ..............................................................................2 4
Ta ble 3.
P har mac o ki netics a n d E C G M o nit ori n g Fl o wc hart ..................................2 5
Ta ble 4.
St u d y  B 1 9 3 1 0 2 2: Efficac y Fi n di n gs f or C R/ C Ri, D o R a n d M R D 
Ne gat i vit y .................................................................................................3 0
Ta ble 5.
St u d y  B 1 9 3 1 0 2 2: P ost H S C T N o n Rela pse M ortalit y Rate by Ar m ........3 4
Ta ble 6.
St u d y  B 1 9 3 1 0 1 0: S u m mar y of He mat ol o gic Re missi o n, Ti me t o 
He mat ol o gic Re missi o n, M R D Ne gati vit y  a n d Ti me t o M R D 
Ne gati vit y  f or P hase 1 D ose Escalati on C o h orts ......................................3 6
Ta ble 7.
St u d y  Inter ve nti o n A d mi nistere d ..............................................................4 7
Ta ble 8.
D osi n g Sc he d ule: I n ot uz u ma b Oz o ga mici n Starti n g D ose of 
1. 8 m g/ m 2/c ycle (a d mi nistere d i n 3 di vi de d d oses) ..................................4 8
Ta ble 9.
V O D Se verit y Gra di n g ( Patie nts Bel o n g t o t he Cate g or y t hat 
F ulfills T w o or M ore Criteria) ..................................................................7 1
Ta ble 1 0.
Pr ot oc ol -Re q uire d Safet y L a b orat or y Assess me nts .................................9 0
LI S T O F FI G U R E S
Fi g ure 1.
St u d y  B 1 9 3 1 0 2 2: Ka pla n Meier C ur ve f or O verall S ur vi val (I nte nt 
t o Treat P o p ulati o n).................................................................................. 3 1
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1
1. P R O T O C O L S U M M A R Y
1. 1. S y n o psis 
Pr ot oc ol Title:
A P H A S E 4, O P E N -L A B E L, SI N G L E -A R M, M U L TI C E N T E R S T U D Y O F 
I NO T U Z U M A B O Z O G A MI CI N I N C HI N E S E A D U L T P A TI E N T S WI T H R E L A P S E D 
O R R E F R A C T O R Y C D 2 2- P O SI TI V E A C U T E L Y M P H O B L A S TI C L E U K E MI A ( A L L)
Brief Title:
A P hase 4 ,o pe n -la bel, si n gle-ar m, m ultice nter st u d y i n C hi nese patie nts wit h rela pse d or 
refract or y cl uster of differe ntiati o n ( C D)- 2 2-p ositi ve B -cell ac ute l ym p h o blastic le u ke mia 
( A L L).
R ati o n ale
T his st u d y  is a p ost a p pr o val c o m mit me nt st u d y t o c o nfir m t he efficac y, safet y, a n d 
p har mac o ki netics ( P K) of i n ot uz u ma b oz o ga mici n i n patie nts wit h rela pse d or refract or y  B
cell A L L fr o m mai nla n d C hi na.
O bjecti ves, Esti m a n ds, a n d E n d p oi nts
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y:

T o e val uate t he efficac y of 
i n ot uz u ma b oz o ga mici n base d o n a 
pri mar y e n d p oi nt of c o m plete 
re missi o n [ C R]/c o m plete 
re missi o n wit h i nc o m plete 
he mat ol o gic rec o ver y [ C Ri] per 
I n vesti gat or’s assess me nt i n 
C hi nese a d ult patie nts wit h 
rela pse d/refract or y B-cell A L L.

T he treat me nt effect of 
i n ot uz u ma b oz o ga mici n fr o m 
t he ti me of first d ose u ntil e n d 
of treat me nt f or all patie nts 
w h o recei ve d at least o ne d ose 
of i n ot uz u ma b oz o ga mici n 
re gar dless of t olera bilit y a n d 
d urati o n o n treat me nt.

C R/ C Ri per i n vesti gat or ’s 
assess me nt.
Sec o n d ar y:

T o e val uate t he efficac y of 
i n ot uz u ma b oz o ga mici n.

D urati o n of re missi o n ( D o R).

Mi ni mal resi d ual disease
( M R D) 
ne gati vit y i n patie nts ac hie vi n g 
C R/ C Ri.

Pr o gressi o n- free s ur vi val ( P F S).

O verall s ur vi val ( O S).

He mat o p oietic ste m cell tra ns pla nt
( H S C T). 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2
O bjecti ves
Esti m a n ds
E n d p oi nts

T o e val uate t he safet y of 
i n ot uz u ma b oz o ga mici n.

T o e val uate P K of i n ot uz u ma b 
oz o ga mici n.

T o e val uate t he i m m u n o ge nicit y of 
i n ot uz u ma b oz o ga mici n.

A Es a n d la b orat or y a b n or malities 
b y t y pe, fre q ue nc y, se verit y (as 
gra de d b y N CI C T C A E v 5. 0), 
ti mi n g, seri o usness, a n d 
relati o ns hi p t o st u d y t hera p y,
i ncl u di n g ve n o -occl usi ve disease
[ V O D] (t otal, d uri n g st u d y 
treat me nt, a n d p ost-H S C T).

I n ot uz u ma b oz o ga mici n ma xi m u m 
o bser ve d c o nce ntrati o n ( C ma x ) a n d 
tr o u g h plas ma c o nce ntrati o n 
( Ctr o u g h).

I nci de nce of a nti-dr u g a nti b o dies 
( A D A) a n d ne utralizi n g a nti b o dies 
( N A b).
O ver all Desi g n
T his is a n o pe n -la bel, si n gle-ar m, m ultice nter st u d y i n C hi nese patie nts wit h rela pse d or 
refract or y C D 2 2-p ositi ve B -cell A L L. T he o bjecti ve of t he st u d y is t o c o nfir m t he efficac y, 
safety, a n d P K of i n ot uz u ma b oz o ga mici n i n patie nts wit h rela pse d or refract or y B -cell A L L 
fr o m mai nla n d C hi na.
A p pr o xi mate 4 4 mai nla n d C hi nese a d ult ( ≥1 8 y ears) patie nts w h o i nte n d t o recei ve eit her 
Sal va ge 1 or 2 t hera p y wit h rela pse d or refract or y  C D 2 2-p ositi ve, P hila del p hia c hr o m os o me
p ositi ve (P h + ) or P hila del p hia c hr o m os o me -ne gati ve ( P h -) B-cell A L L will be e nr olle d i n t he 
st u d y. T o reflect t he ge neral rela pse d/refract or y  A L L patie nt p o p ulati o n, t he n u m ber of 
patie nts wit h P h + disease will be ca p pe d at a p pr o xi matel y 2 0 % of t he e ntire trial p o p ulati o n.

Sal va ge 1: M or p h ol o gical rela pse after i nitial treat me nt or resista nt disease ( n o 
C R/ C Ri) after i nitial treat me nt;

Sal va ge 2: M or p h ol o gical rela pse after sal va ge 1 t hera p y or resista nt disease after 
salva ge 1;
F or t his st u d y , m or p h ol o gic rela pse or resista nt/refract or y disease will be defi ne d as ≥5 % 
blast b y  m or p h ol o gic marr o w assess me nt ( or b y t he prese nce of circ ulati n g blasts if b o ne 
marr o w was n ot assesse d). T hera p y m o dificati o n(s) res ulti n g fr o m is olate d m olec ular 
rela pse, i n t he a bse nce of m or p h ol o gic rela pse, will n ot be c o nsi dere d a sal va ge t hera p y.
T he d osi n g re gi me n f or i n ot uz u ma b oz o ga mici n i n t his st u d y  will be t he sa me as t hat use d i n 
Nati o nal Me dical Pr o d ucts A d mi nistrati o n ( N M P A) -a p pr o ve d la beli n g.  Patie nts will be 
treate d wit h i n ot uz u ma b oz o ga mici n f or a ma xi m u m d ose of 1. 8 m g/ m2 per c y cle wit h a s plit 
d ose re gi me n usi n g wee kl y  a d mi nistrati o ns.  Patie nts will recei ve 0. 8 m g/ m2 o n wee k 1, 
f oll o we d by 0. 5 m g/ m 2 o n wee ks 2 a n d 3 e ver y  2 1- 2 8 d a y s c ycle.  I n C ycle 2 a n d be y o n d, t he 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 3
i n ot uz u ma b oz o ga mici n d ose a d mi nistere d o n wee k 1 will be re d uce d t o 0. 5 m g/ m2 i n 
patie nts ac hie vi n g C R/ C Ri (f or a t otal c y cle d ose of 1. 5 m g/ m 2). 
Patie nts w h o d o n ot ac hie ve a C R or C Ri wit hi n 3 c y cles s h o ul d disc o nti n ue treat me nt .  F or 
patie nts pla n ni n g t o recei ve a n H S C T, it is rec o m me n de d t hat treat me nt wit h i n ot uz u ma b 
oz o ga mici n be li mite d t o 2 c y cles of i n d ucti o n , a t hir d c ycle ma y be gi ve n if C R/ C Ri a n d 
mi ni mal resi d ual disease ( M R D) ne gati vit y  is n ot ac hie ve d after 2 c ycles.  F or patie nts n ot 
pr ocee di n g t o H S C T, a d diti o nal c y cles of treat me nt, u p t o a ma xi m u m of 6 c y cles, ma y be 
a d mi nistere d.
Patie nts w h o ac hie ve a res p o nse t o treat me nt a n d w h o ha ve a s uita ble d o n or ma y u n der g o 
ste m-cell tra ns pla ntati o n at t he discreti o n of t he i n vesti gat or.  N o ass ociati o n bet wee n t he 
ti me fr o m last d ose of i n ot uz u ma b oz o ga mici n t o H S C T a n d o utc o mes after H S C T has bee n 
o bser ve d.  T he p ote ntial ris k of rela pse after t he last d ose of i n ot uz u ma b oz o ga mici n m ust be 
bala nce d a gai ns t t he p ote ntial ris k of t o xicit y ass ociate d wit h be gi n ni n g H S C T s o o n after t he 
last d ose of i n ot uz u ma b oz o ga mici n. 
All cases of V O D/si n us oi dal o bstr ucti o n s y n dr o me ( S O S) irres pecti ve of ca usalit y  or se verity 
will be re p orte d as seri o us a d verse e ve nts ( S A E s) f or u p t o 2 years after t he first d ose of 
i n ot uz u ma b oz o ga mici n.  A n i n de pe n de nt he patic e ve nt a dj u dicati o n c o m mittee will e val uate 
safety f or p ote ntial V O D/ S O S e ve nts a n d H y ’s la w cases.  S ur vi val will be f oll o w e d u p t o 2 
ye ars fr o m first d ose.
P K sa m ples will be c ollecte d f or all 4 4 patie nts i n t he st u d y t o descri be p o p ulati o n P K 
pr ofiles.
N u m ber of P artici p a nts
A p pr o xi matel y 4 4 mai nla n d C hi nese a d ult ( ≥1 8 years) patie nts w h o i nte n d t o recei ve eit her 
Sal va ge 1 or 2 t hera p y wit h rela pse d or refract or y  C D 2 2-p ositi ve, P h + or P h - B-cell A L L 
will be e nr olle d i n t he st u d y. T he statistical c o nsi derati o n f or t he sa m ple size is des cri be d i n 
Secti o n 9. 2 .
N ote: " E nr olle d" mea ns a partici pa nt's, or t heir le gall y a ut h orize d re prese ntati ve’s, a gree me nt 
t o partici pate i n a cli nical st u d y f oll o wi n g c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d 
assi g n me nt t o st u d y i nter ve nti o n.
St u d y P o p ul ati o n 
K e y i ncl usi o n a n d e xcl usi o n criteria are liste d bel o w:
I ncl usi o n Criteri a
Partici pa nts m ust meet t he f oll o wi n g k e y  i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y:
1.
Male or fe male partici pa nts, a ge 1 8 y ears or ol der at scree ni n g.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 4
2.
Rela pse d or refract or y  C D 2 2- p ositi ve A L L ( ≥5 % marr o w blasts, assesse d b y  
m or p h ol o g y ) d ue t o recei ve eit her sal va ge 1 or sal va ge 2 t hera p y a n d f or w hic h 
treat me nt wit h i n ot uz u ma b oz o ga mici n offers a reas o na ble treat me nt o pti o n.
3.
P h + A L L patie nts m ust ha ve faile d treat me nt wit h at least 1 t y r osi ne ki nase i n hi bit or 
a n d sta n dar d m ulti -a ge nt i n d ucti o n c he m ot hera p y.
4.
Patie nts i n Sal va ge 1 wit h late rela pse s h o ul d be dee me d p o or ca n di dates f or 
rei n d ucti o n wit h i nitial t hera py.
5.
Patie nts wit h l y m p h o blastic l y m p h o ma a n d b o ne marr o w i n v ol ve me nt ≥5 % 
l ym p h o blasts b y  m or p h ol o gic assess me nt.
6.
E C O G perf or ma nce stat us 0 - 2.
7.
A de q uate li ver f u ncti o n, i ncl u di n g t otal ser u m bilir u bi n ≤1. 5 × U L N u nless t he patie nt 
has d oc u me nte d Gil bert s y n dr o me, a n d as partate a n d ala ni ne a mi n otra nsferase ( A S T 
a n d A L T) ≤2. 5 × U L N.  If or ga n f u ncti o n a b n or malities are c o nsi dere d d ue t o t u m or, 
t otal ser u m bilir u bi n m ust be ≤2 × U L N a n d A S T/ A L T ≤2. 5 × U L N.
8.
Ser u m creati ni ne ≤1. 5 × u p per li mit of n or mal ( U L N) or a n y s er u m creati ni ne le vel 
ass ociate d wit h a meas ure d or calc ulate d creati ni ne cleara nce of ≥4 0 m L/ mi n.
9.
Male a n d fe male patie nts of c hil d beari n g p ote ntial a n d at ris k f or pre g na nc y  m ust a gree 
t o use a hi g hly effecti ve met h o d of c o ntrace pti o n t hr o u g h o ut t he st u d y a n d f or a 
mi ni m u m of 8 m o nt hs (fe males) a n d 5 m o nt hs ( males) after t he last d ose of assi g ne d 
treat me nt.  A patie nt is of c hil d beari n g p ote ntial if, i n t he o pi ni o n of t he In vesti gat or, 
he/s he is bi ol o gicall y ca pa ble of ha vi n g c hil dre n a n d is se x uall y  acti ve.  Fe male 
s u bjects of n o nc hil d beari n g p ote ntial m ust meet at least 1 of t he f oll o wi n g criteria: 
a
Ac hie ve d p ost me n o pa usal stat us, defi ne d as f oll o ws: cessati o n of re g ular me nses 
f or at least 1 2 c o nsec uti ve m o nt hs wit h n o alter nati ve pat h ol o gical or p h ysi ol o gical 
ca use; a n d ha ve a ser u m f ollicle sti m ulati n g h or m o ne ( F S H) le vel c o nfir mi n g t he 
p ost me n o pa u sal state;
b
Ha ve u n der g o ne a d oc u me nte d h y sterect o m y a n d/ or bilateral o o p h orect o m y; 
c
Ha ve me dicall y  c o nfir me d o varia n fail ure. 
All ot her fe male s u bjects (i ncl u di n g fe male s u bjects wit h t u bal li gati o ns) are c o nsi dere d t o 
be of c hil d beari n g p ote ntial. 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 5
E xcl u si o n Criteri a 
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti o ns will be e xcl u de d:
Me dic al C o n diti o ns:
1.
Is olate d e xtra me d ullar y rela pse (ie, testic ular or ce ntral ner v o us sys te m [ C N S]).
2.
B ur kitt’s or mi xe d p he n ot y pe ac ute le u ke mia base d o n t h e W orl d Healt h 
Or ga nizati o n ( W H O) 2 0 0 8 criteria.
3.
Acti ve C N S le u ke mia, as defi ne d b y u ne q ui v ocal m or p h ol o gic e vi de nce of 
l ym p h o blasts i n t he cere br os pi nal fl ui d ( C S F), use of C N S - directe d l ocal treat me nt 
f or acti ve disease wit hi n t he pri or 2 8 da ys, s ym pt o matic C N S le u ke mia (ie, cra nial 
ner ve palsies or ot her si g nifica nt ne ur ol o gic d ys f u ncti o n) wit hi n 2 8 da ys.  
Pr o p h y lactic i ntrat hecal me dicati o n is n ot a reas o n f or e xcl usi o n.
4.
Maj or s ur ger y
wit hi n ≤4 wee ks bef ore C y cle 1 Da y 1.
5.
U nsta ble or se vere u nc o ntr olle d me dical c o n diti o n (e g, u nsta ble car diac f u ncti o n or 
u nsta ble p ul m o nar y c o n diti o n).
6.
C o nc urre nt acti ve mali g na nc y ot her t ha n n o n -mela n o ma s ki n ca ncer, carci n o ma i n 
sit u of t he cer vi x, or l ocalize d pr ostate ca ncer t hat has bee n defi nitel y treate d with 
ra diati o n or s ur ger y.  Patie nts wit h pre vi o us mali g na ncies are eli gi ble pr o vi de d t hat 
t he y ha ve bee n disease free f or ≥2 years.
7.
Car diac f u ncti o n, as meas ure d b y left ve ntric ular ejecti o n fracti o n ( L V E F) t hat is less
t ha n 4 5 %, or t he prese nce of Ne w Y or k Heart Ass ociati o n ( N Y H A) sta ge III or I V
c o n gesti ve heart fail ure.
8.
Patie nts wit h acti ve heart disease ( N Y H A class ≥3 as assesse d b y hist or y a n d p h y sical
e xa mi nati o n).
9.
M y ocar dial i nfarcti o n ≤6 m o nt hs bef ore C ycle 1 Da y 1.
1 0. Hist or y  of cli nicall y si g nifica nt ve ntric ular arr h yt h mia, or u ne x plai ne d s y nc o pe n ot 
belie ve d t o be vas o va gal i n nat ure, or c hr o nic bra d y car dic states s uc h as si n oatrial 
bl oc k or hi g her de grees of atri o ve ntric ular ( A V) bl oc k u nless a per ma ne nt pace ma ker 
has bee n i m pla nte d.
1 1. U nc o ntr olle d ele ctr ol yt e dis or ders t hat ca n c o m p o u n d t he effects of a Q Tc pr ol o n gi n g 
dr u g (e g, h y p o kale mia, h y p ocalce mia, h y p o ma g nese mia).
1 2. Hist or y  of c hr o nic li ver disease (e g, cirr h osis) or s us pecte d alc o h ol a b use.
1 3. Hist or y  of he patic ve n o-occl usi ve disease ( V O D) or si n us oi dal o bstr ucti o n s y n dr o me 
( S O S).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 6
1 4. E vi de nce of u nc o ntr olle d c urre nt seri o us acti ve i nfecti o n (i ncl u di n g se psis, 
bactere mia, f u n ge mia) or patie nts wit h a rece nt hist or y  ( wit hi n 4 m o nt hs) of dee p 
tiss ue i nfecti o ns s uc h as fascitis or oste o m yelitis.
1 5. Patie nts w h o ha ve ha d a se vere aller gic reacti o n or a na p h yl actic reacti o n t o a n y 
h u ma nize d m o n ocl o nal a nti b o dies.
1 6. Ot her ac ute or c hr o nic me dical or ps yc hi atric c o n diti o n i ncl u di n g rece nt ( wit hi n t he 
past y ear) or acti ve s uici dal i deati o n or be ha vi or or la b orat or y  ab n or malit y  t hat ma y 
i ncrease t he ris k ass ociate d wit h st u d y partici pati o n or i n vesti gati o nal pr o d uct 
a d mi nistrati o n or ma y i nterfere wit h t he i nter pretati o n of st u d y res ults a n d, i n t he 
j u d g me nt of t he i n vesti gat or, w o ul d ma ke t he partici pa nt i na p pr o priate f or e ntr y i nt o 
t his st u d y.
Pri or/ C o nc o mit a nt T her a p y:
1 7. Pri or c he m ot hera p y wit hi n 2 wee ks bef ore e nr oll me nt wit h t he f oll o wi n g e xce pti o ns:
a.
T o re d uce t he circ ulati n g l y m p h o blast c o u nt or palliati o n: ster oi ds, h y dr o x y urea 
or vi ncristi ne;
b.
F or A L L mai nte na nce: merca pt o p uri ne, met h otre xate, vi ncristi ne, t hi o g ua ni ne,
a n d/ or t yr osi ne ki nase i n hi bit ors.
1 8. Patie nts m ust ha ve rec o vere d fr o m ac ute n o n he mat ol o gic t o xicit y  (t o ≤Gra de 1) of all 
pre vi o us t hera p y  pri or t o e nr oll me nt.
1 9. Pri or m o n ocl o nal a nti b o dies wit hi n 6 wee k s of e nr oll me nt, wit h t he e xce pti o n of 
rit u xi ma b w hic h m ust be disc o nti n ue d at least 2 wee ks pri or t o C y cle 1 Da y 1.
2 0. Pri or all o ge neic he mat o p oietic ste m cell tra ns pla nt ( H S C T) or ot her a nti -C D 2 2 
i m m u n ot hera p y ≤4 m o nt hs bef ore e nr oll me nt.  Patie nts m ust ha ve c o m plete d 
i m m u n os u p pressi o n t hera p y f or treat me nt of graft vers us h ost disease ( G v H D ) pri or 
t o e nr oll me nt.  At e nr oll me nt , patie nts m ust n ot ha ve ≥Gra de 2 ac ute G v H D, or 
e xte nsi ve c hr o nic G v H D.
2 1. A d mi nistrati o n of li ve vacci ne ≤6 wee ks bef ore e nr oll me nt.
P ri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
2 2. Pre vi o us a d mi nistrati o n wit h a n i n vesti gati o nal dr u g wit hi n 3 0 d a y s ( or as deter mi ne d 
b y  t he l ocal re q uire me nt) or 5 half -li ves prece di n g t he first d ose of i n vesti gati o nal 
pr o d uct use d i n t his st u d y  ( w hic he ver is l o n ger).
Di a g n ostic Assess me nts:
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 7
2 3. Peri p heral a bs ol ute l y m p h o blast c o u nt ≥1 0, 0 0 0 / µ L (treat me nt wit h h y dr o x y urea 
a n d/ or ster oi ds/ vi ncristi ne is per mitte d wit hi n 2 wee ks of C ycle 1 Da y 1 t o re d uce t he 
w hite bl o o d cell [ W B C] c o u nt).
2 4. K n o w n s y ste mic vasc uliti des (e g, We ge ner’s gra n ul o mat osis, p ol yarteritis n o d osa, 
s yste mic l u p us er yt he mat os us), pri mar y or sec o n dar y i m m u n o deficie nc y (s uc h as 
h u ma n i m m u n o deficie nc y vir us [ HI V] i nfecti o n or se vere i nfla m mat or y  disease).
2 5. C urre nt or c hr o nic he patitis B or C i nfecti o n as e vi de nce d b y he patitis B s urface 
a nti ge n a n d a nti -he patitis C a nti b o d y  p ositi vit y, res pecti vel y, or k n o w n ser o p ositi vit y 
f or HI V.  HI V testi n g ma y nee d t o be perf or me d i n acc or da nce wit h l ocal re g ulati o ns 
or l ocal practice.
2 6. Q Tc F > 4 7 0 msec ( base d o n t he a vera ge of 3 c o nsec uti ve electr ocar di o gra ms [ E C Gs]).
Ot her E xcl usi o ns:
2 7. I n vesti gat or site staff me m bers directly i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir 
fa mil y me m bers, site staff me m bers ot her wise s u per vise d b y t he i n vesti gat or, or 
Pfizer e m pl o yees, i ncl u di n g t heir fa mil y me m bers, directl y i n v ol ve d i n t he c o n d uct of 
t he st u d y. 
2 8. Pre g na nt fe male s u bjects; breastfee di n g fe male s u bjects; fertile male s u bjects a n d 
fe male s u bjects of c hil d beari n g p ote ntial w h o are u n willi n g or u na ble t o use hi g hly 
effecti ve c o ntrace pti o n as o utli ne d i n t his pr ot oc ol f or t he d urati o n of t he st u d y a n d 
f or a mi ni m u m of 8 m o nt hs (fe males) a n d 5 m o nt hs ( males) after t he last d ose of 
i n vesti gati o nal pr o d uct.
St u d y Ar ms a n d D ur ati o n
T he d osi n g re gi me n f or i n ot uz u ma b oz o ga m ici n i n t he C hi na p ost a p pr o val st u d y will be t he 
sa me as t hat use d i n N M P A-a p pr o ve d la beli n g as s u m marize d bel o w:
C y cle 1: 1. 8 m g/ m 2 i n ot uz u ma b oz o ga mici n ( Da y 1: 0. 8 m g/ m2, Da y 8 a n d Da y 1 5: 
0. 5 m g/ m 2), C y cle 1 c o nsists of 3 wee k s.  H o we ver, t he d urati o n m a y  be e xte n de d 
t o 4 wee ks if t he patie nt ac hie ves a C R or C Ri a n d/ or t o all o w t o xicit y rec o ver y.
F or s u bse q ue nt c y cles ( 4 wee ks i n d urati o n): 

I n patie nts w h o ac hie ve a C R or C Ri: 1. 5 m g/ m2 per c ycl e ( Da ys 1, 8, a n d 1 5: 
0. 5 m g/ m 2), su bse q ue nt c y cles are 4 wee ks i n d urati o n .

I n patie nts w h o d o n ot ac hie ve a C R or C Ri: 1. 8 m g/ m2 per c y cle ( Da y 1: 
0. 8 m g/ m 2, Da ys 8 a n d 1 5: 0. 5 m g/ m 2).  Patie nts w h o d o n ot ac hie ve a C R or C Ri 
wit hi n 3 c y cles s h o ul d disc o nti n ue treat me nt.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 8
F or patie nts pr ocee di n g t o H S C T, t he r ec o m me n de d d urati o n of treat me nt is 2 c y cles. 
A t hir d c y cle ma y be c o nsi dere d f or t h ose patie nts w h o d o n ot ac hie ve C R or C Ri 
a n d M R D ne gati vit y after 2 c ycles.
F or patie nts n ot pr ocee di n g t o H S C T, a d diti o nal c y cles of treat me nt, u p t o a 
ma xi m u m of 6 c ycles, ma y be a d mi nistere d.
F oll o wi n g t he disc o nti n uati o n fr o m t he treat me nt, patie nts will be f oll o we d f or:
1.
D isease pr o gressi o n f or u p t o 2 years fr o m t he first d ose, u nless t he disease 
pr o gresse d d uri n g t he treat me nt;
2.
P ote ntial V O D/ S O S cases, irres pec ti vely of gra de or ca usalit y f or u p t o 2 years 
fr o m t he first d ose;
3.
S ur vi val f or u p t o 2 y ears fr o m t he first d ose.
St atistic al Met h o ds
T he statistical met h o ds a n d a nal ys es f or t he st u d y will be descri be d detail i n t he statistical 
a nal ys is pla n ( S A P).
S pec ifically, t he st u d y will test t he n ull h y p ot hesis H 0: C R/ C Ri rate per i n vesti gat or’s 
assess me nt ≤3 7 % vs t he alter nati ve h y p ot hesis H a: C R/ C Ri rate ≥6 1 % w here b ot h h y p ot heses 
are c o nsiste nt wit h t h ose fr o m st u d y  B 1 9 3 1 0 2 2.
A sa m ple size of 4 4 patie nts is pla n ne d t o pr o vi de at least 9 0 % p o wer t o reject t he n ull 
h y p ot hesis w he n t he tr ue C R/ C Ri rate ≥6 1 % u n der t he 1 -si de d si g nifica nce le vel 0. 0 2 5.
All ot her sec o n dar y  e n d p oi nts will be descri pti vel y s u m marize d.  Ka pla n-Meier met h o d will 
be use d t o s u m marize t he t i me-t o-e ve nt varia bles i ncl u di n g d urati o n of re missi o n ( D o R), 
pr o gressi o n -free s ur vi val ( P F S) a n d o verall s ur vi val ( O S).
All safet y a nal ys is will be perf or me d o n t he safety p o p ulati o n.  T he n u m ber a n d perce nta ge 
of patie nts wit h a d verse e ve nts will be s u m marize d b y Me dical Dicti o nar y f or Re g ulat or y 
Acti vities ( Me d D R A) s yste m or ga n class, preferre d ter m, relati o ns hi p t o st u d y dr u g, a n d 
se verity.
A nal y ses of t he P K data will be c o n d ucte d o n t he P K c o nce ntrati o n p o p ulati o n.  Descri pti ve 
s u m mar y statistics will be pr o vi de d.
T he a nti -dr u g a nti b o d y ( A D A) a n d N A b data are t o be liste d a n d s u m marize d t hr o u g h 
fre q ue nc y a n d perce nta ge.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 9
1. 2. Sc he m a
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 0
1. 3. Sc he d ule of Acti vities ( S o A)
T he S o A ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures.  Refer t o t he S T U D Y A S S E S S M E N T S A N D 
P R O C E D U R E S secti o n of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he 
pr ot oc ol. 
T he i n vesti gat or ma y  sc he d ule visits ( u n pla n ne d visits) i n a d ditio n t o t h ose liste d i n t he S o A ta ble, i n or der t o c o n d uct e val uati o ns or 
assess me nts re q uire d t o pr otect t he well -bei n g of t he partici pa nt.  
T a ble 1 .
Sc he d ule of Acti vities
Pr ot oc ol Acti vit y
Scree n 1 7
-2 8 da ys fr o m
e nr oll me nt
C ycles 1- 6 
E n d of Tre at me nt
( E O T)1 9
( All patie nts: 4 we e ks fr o m t h e
last d ose of st u d y dr u g)
D a y 1
D a y 8
D a y 1 5
St u d y Visit Wi n d o w ( Da ys)
± 2
± 2
± 2
± 3
Inf or me d c o nse nt & Partici pa nt I D n u m ber & Distri b ute 
e mer ge nc y c o ntact car d
X
E li gi bilit y criteria
X
C o ntrace pti o n c hec k
X
X
X
C D 2 2 I m m u n o p he n ot y pi n g1
X
A nti b o dies t o i n ot uz u ma b2
X
X
De m o gra p h y /Me dical Hist or y
X
Wei g ht/ hei g ht
4
X
X
X
Vital Si g ns a n d P h ysical E xa mi nati o n 3
X
X
X
X
X
E C O G perf or ma nce stat us ( P S)
X
X
La b orat or y Assess me nts: D uri n g t he treat me nt peri o d, all la b orat or y assess me nts m ust be d o ne wit hi n 7 2 h o urs pri or t o d osi n g.
He mat ol o g y 5
X
X
X
X
X
Bl o o d C he mistr y 5
X
X
X
X
X
Uri nal ysis 7
X
X
C oa g ulati o n 8
X
X
X
Pre g na nc y test 9
X
X
X
H bs A g a n d a nti - he patitis C vir us ( H C V) 6
X
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 1
T a ble 1 .
Sc he d ule of Acti vities
Pr ot oc ol Acti vit y
Scree n 1 7
-2 8 da ys fr o m
e nr oll me nt
C ycles 1- 6 
E n d of Tre at me nt
( E O T)1 9
( All patie nts: 4 we e ks fr o m t h e
last d ose of st u d y dr u g)
D a y 1
D a y 8
D a y 1 5
C hest X -ra y (or C T b y cli nical re q uest )
X
E C G (i n tri plicate)1 0
X ( 3 -2 8 da ys pri or 
t o e nr oll me nt )
See Ta ble 3 f or a d diti o nal ti me
p oi nts
X
P har mac o ki netics 
See Ta ble 3 for ti me p oi nts
L V E F 1 1
X
Pre me dicati o ns
X
X
X
St u d y Treat me nts 1 2
S ee pr ot oc ol Secti o n 6
B o ne marr o w as pirate a n d cli nical disease 
assess me nts 1 3
X
See Ta ble 1 f o ot n ote1 3
X
Kar y ot y pi n g/ FI S H/
I m m u n o p he n ot y pi n g/ Mi ni mal resi d ual disease 
( M R D)/ B o ne marr o w bi o ps y 1 4
X
D o ne i n patie nts wit h s us pecte d C R a n d/ or C Ri 1 4
Ra di ol o gical Assess me nt 1 5
X
As cli nicall y i n dicate d.  See A p pe n di x 7 .
Assess me nt of C N S disease 1 8
X 1 8
As cli nicall y i n dicated 1 8
A E/ S A E a n d c o nc o mita nt me dicati o ns 1 6
X
Assesse d t hr o u g h o ut t he st u d y u ntil 9 wee ks fr o m last d ose of i n ot uz u ma b oz o ga mici n
A d diti o nal pr oce d ures or sa m ples ma y be u n derta ke n as me dicall y re q uire d at t he discreti o n of t he I n vesti gat or.  Data ma y be rec or de d o n t he C R F (e g, l ocal M R D a nal ysis if d o ne 
at t he site).  A d diti o nal bl o o d sa m ples ma y be ta ke n, or a d diti o nal tests c o n d ucte d i n e xisti n g sa m ples, f or a nal yses at ce ntral or l ocal la b orat ories i n or d er t o pr o vi de t he best 
p ossi ble g ui da nce o n i m pr o vi n g t he me dical ma na ge me nt of st u d y patie nts o n e mer gi n g safet y fi n di n gs d uri n g t he c o n d uct of t he st u d y.
1.
C D 2 2 i m m u n o p he n ot y pi n g perf or me d at scree ni n g o n peri p heral bl o o d or b o ne marr o w as pirate.  S urface C D 2 2 e x pressi o n s h o ul d be meas ure d b y F A C S; 
i m m u n o hist oc he mistr y (I H C) a nal ysis is all o we d i n patie nts wit h 1) dr y ta p or 2) if B M as pirate was i na de q uate a n d/ or wit h i ns ufficie nt circ ulati n g blasts f or F A C S..
2.
I m m u ne res p o nse testi n g t o i n ot uz u ma b oz o ga mici n: bl o o d sa m ple will be c ollecte d at Da y 1 of e ver y c ycle pri or t o t he be gi n nin g of i n ot uz u ma b oz o ga mici n i nf usi o n a n d at 
t he e n d-of -treat me nt visit.  A nal ysis will be perf or me d b y ce ntral la b orat or y.
3.
P h ysical e xa mi nati o n ( P E) perf or me d at scree ni n g a n d at Da y 1, 8 a n d 1 5 of e ver y c ycle pri or t o st u d y dr u g a d mi nistrati o n.  V ital si g ns ( p ulse, bl o o d press ure, te m p) re q uire d 
o n e ver y d a y of d osi n g. Rec or d vital si g ns pri or t o eac h i nf usi o n a n d 1 h o ur ( ± 1 5 mi n utes) after t he e n d of eac h i nf usi o n. Vital si g ns will be als o rec or de d 2 h o urs 
( ±1 5 mi n utes) after t he e n d of i n ot uz u ma b oz o ga mici n i nf usi o n at C ycle 1 Da y 1 d ose.
4.
Hei g ht re q uire d o nl y at scree ni n g; patie nts m ust be wei g he d u p t o 7 2 h o urs pri or t o Da y 1 of eac h c ycle a n d e n d -of -treat me nt.  If t he patie nt e x perie nces a wei g ht l oss or gai n 
> 1 0 % fr o m t he pri or wei g ht o btai ne d, t he B S A a n d t he a m o u nt of i n ot uz u ma b oz o ga mici n re q uire d f o r d ose pre parati o n m ust be re-calc ulate d. 
5.
Ser u m c he mistr y a n d He mat ol o g y: perf or me d at scree ni n g t o deter mi ne eli gi bilit y, u p t o 7 2 h o urs pri or t o Da y 1, Da ys 8 a n d 1 5 of e ver y c ycle.  A d diti o nal ( u nsc he d ule d) 
assess me nts s h o ul d be d o ne if la b orat or y val u es are a b n or mal ( or if cli nicall y i n dic ate d) a n d re peate d u ntil res ol uti o n, u ntil ret ur n t o baseli ne, or u ntil N CI C T C A E Gra de ≤1.  
A C B C wit h platelets a n d differe ntial m ust acc o m pa n y eac h b o ne marr o w assess me nt.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 2
T a ble 1 .
Sc he d ule of Acti vities
Pr ot oc ol Acti vit y
Scree n 1 7
-2 8 da ys fr o m
e nr oll me nt
C ycles 1- 6 
E n d of Tre at me nt
( E O T)1 9
( All patie nts: 4 we e ks fr o m t h e
last d ose of st u d y dr u g)
D a y 1
D a y 8
D a y 1 5
6.
He patitis B ( H bs A g) a n d C (a nti -H C V) tests .  A rec o m bi na nt i m m u n o bl ot assa y ( RI B A) or n ucleic aci d test ( N A T) ma y be d o ne t o c o nfir m or r ule o ut H C V i nfecti o n as 
cli nicall y i n dicate d .
7.
Uri nal ysis: c o n d ucte d at scree ni n g, wit hi n 7 2 h o urs pri or t o d osi n g of C ycle 4 Da y 1, a n d t he e n d -of -treat me nt visit.  Uri ne pr otei n t o creati ni ne rati o will be calc ulate d at 
scree ni n g a n d E n d of treat me nt o nl y.
8.
C oa g ulati o n: P T/I N R c ollecte d at scree ni n g, u p t o 7 2 h o urs pre d ose of Da y 1 of eac h c ycle a n d E O T.  P T T or A P T T re q uire d at s cree ni n g a n d e n d -of -treat me nt visits o nl y
9.
F or w o me n of c hil d beari n g p ote ntial, beta -h u ma n c h ori o nic g o na d otr o pi n ( -H C G) ser u m or uri ne pre g na nc y test will be perf or me d at scree ni n g, u p t o 7 2 h o urs pri or t o 
d osi n g at Da y 1 eac h c ycle, a n d E O T.  A d diti o nal pre g na nc y tests ma y be d o ne as re q uire d b y l ocal re g ulati o ns a n d/ or E C/I R Bs.
1 0.
E C Gs will be d o ne i n tri plicate ( 3 c o nsec uti ve E C Gs a p pr o xi matel y 2 mi n utes a part) i n all patie nts at scree ni n g, d uri n g treat me nt C ycles 1, 2 a n d 4, a n d E O T.  Scree ni n g 
E C G will be d o ne a p pr o xi matel y 3- 2 8 da ys pr i or t o e nr oll me nt.
1 1.
L V E F will be assesse d at scree ni n g eit her b y ec h ocar di o gra m ( E C H O) or M ulti gate d Ac q uisiti o n Sca n ( M U G A).  A d diti o nal assess m e nts ma y be d o ne d uri n g t he st u d y if 
cli nicall y re q uire d.
1 2.
Patie nts m ust be treate d wit hi n 3 da ys fr o m e nr oll me nt .  If e xte n uati n g circ u msta nces pre ve nt a patie nt fr o m be gi n ni n g treat me nt wit hi n t his ti me, t he patie nt ma y be gi n 
treat me nt o nl y wit h writte n per missi o n b y t he Pfizer Cli nicia n.
1 3.
B o ne marr o w as pirate a n d disease assess me nts will be perf or me d at scree ni n g, at Da y 1 6 -2 8 of C ycles 1, 2, or u ntil C R/ C Ri a n d M R D ne gati vit y are ac hie ve d . The n after 
e ver y 1 - 2 c ycle as cli nicall y i n dicate d, a n d at E O T visit ( u nless pre vi o usl y d o ne wit hi n 2 8 da ys).  B o ne marr o w as pirates will be a nal yze d at t he st u d y site.  A C B C wit h 
platelets a n d differe ntial m ust acc o m pa n y eac h b o ne marr o w assess me nt.  Disease assess me nts will i ncl u de cli nical e val uati o n of li ver a n d s plee n, a n d ot her sites of pri or or 
s us pecte d e xtra me d ullar y disease.  Disease assess me nts will c o nti n ue u ntil pr o gressi o n.  F or t h ose w h o ha ve n ot pr o gresse d at E O T, disease will be assesse d e ver y 1 2 wee ks
( ± 1 wee k) u p t o 1 year fr o m e nr oll me nt a n d e ver y 2 4 wee ks ( ± 2 wee ks) bet wee n year 1 a n d 2, a n d w he ne ver cli nicall y i n dicate d, u ntil pr o gressi o n.  All disease asses s me nt 
res ults will be ca pt ure d i n t he C R F, e ve n if u n pla n ne d or n ot re q uire d b y pr ot oc ol.
1 4.
Mi ni mal resi d ual diseas e ( M R D): B o ne marr o w as pirate will be c ollecte d at scree ni n g, i n vesti gat or s uspecte d C R / CRi , ac hie ve me nt of C R/ C Ri u ntil M R D ne gati vit y bef ore 
E O T .
M R D will be assesse d usi n g N G S f or rearra n ge d I g H, I g K, a n d I g L rece pt or ge ne se q ue nces at a ce ntral la b orat or y.  
I m m u n o p he n ot y pi n g: perf or me d o n peri p heral bl o o d or b o ne marr o w as pirate wit h fl o w c yt o metr y at scree ni n g a n d will be d o ne i n patie nts wit h s us pecte d C R a n d/ or C Ri. 
I H C is all o we d i n patie nts wit h a dr y ta p or ot her wise i na de q uate b o ne marr o w as pirate i n t he a bse nce of circ ulati n g blasts. T he le u ke mia p he n ot y pe a n d/ or ge n ot y pe ma y als o 
be e val uate d b y ot her test met h o ds at t he discreti o n of t he i n vesti gat or.
FI S H: B o ne marr o w as pirates ma y be a nal yze d b y fl u oresce nce i n sit u h y bri dizati o n a nal ysis ( FI S H) f or detecti o n of c hr o m os o mal a ber rati o ns at scree ni n g acc or di n g t o 
sta n dar d of care.
Kar y ot y pi n g 2 8: i n all patie nts, at scree ni n g a n d at least o nce i n patie nts ac hie vi n g C R or C Ri w h o ha d a b n or mal c yt o ge netics at baseli ne.  It is rec o m me n de d t hat 2 0 or m ore 
meta p hases be c o u nte d f or c yt o ge netics a nal ysis.
B o ne Marr o w Bi o ps y: re q uire d at least o nce, t o assess cell ularit y, i n patie nts wit h C Ri b y i n vesti gat or assess me nt ( A N C < 1 × 1 0 9/ L a n d/ or platelets < 1 0 0 × 1 0 9/ L) a n d as 
cli nicall y i n dicate d per l ocal sta n dar d of care.  Bi o psies ma y be als o re q uire d f or i na de q uate as pirate sa m ples
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 3
T a ble 1 .
Sc he d ule of Acti vities
Pr ot oc ol Acti vit y
Scree n 1 7
-2 8 da ys fr o m
e nr oll me nt
C ycles 1- 6 
E n d of Tre at me nt
( E O T)1 9
( All patie nts: 4 we e ks fr o m t h e
last d ose of st u d y dr u g)
D a y 1
D a y 8
D a y 1 5
1 5.
Ra di ol o gical assess me nts (ie, c o m p ute d t o m o gra p h y sca n or M RI) will be d o ne at scree ni n g f or patie nts wit h s us pecte d e xtra me d ullar y disease, d uri n g stu d y as cli nicall y 
i n dicate d a n d t o c o nfir m C R or C Ri i n patie nts wit h e xtra me d ullar y disease at scree ni n g.  Please use t he sa me met h o d of assess me nt f or eac h e val uati o n.  C o m p ute d 
t o m o gra p h y sca n wit h c o ntrast is t he preferre d met h o d of assess me nt.
1 6.
A Es will be f oll o we d u ntil t he e ve nt or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or, or l o n ge r if re q ueste d b y t he s p o ns or.  T he A E re p orti n g peri o d 
c o nti n ues u ntil 9 wee ks after t he last d ose of i n vesti gati o nal dr u g.  H o we ver, V O D/ S O S e ve nts, irres pecti ve of t he gra de, ca u salit y, will be re p orte d i n t he C R F f or u p t o 2 
years fr o m first d ose a n d will als o be re p orte d as S A Es.
1 7.
Assess me nt(s) a n d test(s) d o ne acc or di n g t o sta n dar d of care at t he i nstit uti o n pri or t o t he patie nt si g ni n g t he I C D ca n be u se d t o deter mi ne patie nt eli gi bilit y if c ollecte d 
wit hi n t he ti mefra me s pecifie d i n t his pr ot oc ol, e. g. pr oce d ure s c o n d ucte d wit hi n 2 8 da ys ( E C G 3-2 8 da ys) pri or t o e nr oll me nt. Res ults will be rec or de d i n t he C R F.  H o we ver 
bef ore a n y c ollecte d sa m ple (e. g. E C G, B M as pirate f or disease assess me nt) is se nt t o t he ce ntral ve n d or, t he patie nt m ust be c o nse nte d f or st u d y partici pati o n.
1 8.
Assess me nt of C N S disease (e g, l u m bar p u nct ure) is re q uire d at scree ni n g i n a n y patie nt wit h a pri or hist or y of C N S disease o r if C N S disease is s us pecte d d ue t o cli nical 
si g ns a n d/ or s y m pt o ms.  If a c o m plete C N S assess me nt is n ot feasi ble due t o c o m or bi dities, t he patie nt ca n n ot be i ncl u de d i n t he st u d y.  If a d diti o nal assess me nts are d o ne at 
t he site, as cli nicall y i n dicate d, res ults m ust be c ollecte d i n t he C R F.  Patie nts wit h hist or y of C N S disease w h o ac hie ve a C R or C Ri m ust ha ve a C N S assess me nt t o c o nfir m 
c o m plete res p o nse.
1 9.
E O T visits s h o ul d be perf or me d bef ore starti n g a ne w a nti -le u ke mic t hera p y (i ncl u di n g bef ore s u bse q ue nt he mat o p oietic ste m cell tra ns pla nt (H S C T) c o n diti o ni n g, ot her f or m 
of c o ns oli dati o n/i nte nsificati o n or mai nte na nce t hera p y).  If a ne w a nti -le u ke mia t hera p y will be starte d, t he E O T visit s h o ul d occ ur as cl ose as p ossi ble t o 4 wee ks after t he 
last d ose of st u d y dr u g.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 4
T a ble 2 .
L o n g Ter m F oll o w -U p
St u d y Pr oce d ures
Dise ase F oll o w -u p 1
S ur vi v al F oll o w -u p 2
St u d y Visit
E ver y 1 2 -2 4 w ee ks 1
E ver y 1 2 w ee ks
Ser u m c he mistr y 3
X
H e m at ol o g y 3
X
C oa g ulati o n test (I N R/ P T) 3
X
E C O G perf or ma nce stat us
X
B o ne marr o w  as pirate a n d disease assess me nts4
X
Ot her a ntica ncer t hera p y 5
X
X
S ur vi val stat us 2
X
X
1.
Disease f oll o w -u p: F or patie nts w h o ha ve disc o nti n ue d treatme nt b ut ha ve n ot pr o gresse d, (i ncl u di n g patie nts u n der g oi n g ste m-cell tra ns pla nt or ot her s u bse q ue nt a nti-le u ke mic 
t hera p y), starti n g a p pr o xi matel y 1 2 wee ks after t he last disease assess me nt , u ntil disease pr o gressi o n f or u p t o 2 years after Da y 1 C ycle 1, disease will be assesse d e ver y
1 2 wee ks ( ±1 wee k) u p t o 1 ye ar fr o m C ycle 1 Da y 1 a n d e ver y 2 4 wee ks ( ± 2 wee ks) bet wee n year 1 a n d 2, a n d w he ne ver cli nicall y i n dicate d, u ntil rela pse.
2.
S ur vi val f oll o w-u p: All patie nts (i ncl u di n g patie nts u n der g oi n g ste m -cell tra ns pla nt or ot her s u bse q ue nt a nti -le u ke mic t hera p y) starti n g a p pr o xi matel y 1 2 wee ks (1 wee k) after
d oc u me nte d disease pr o gressi o n a n d c o nti n ui n g a p pr o xi matel y e ver y 1 2 wee ks ( ± 1 wee k) f or u p t o 2 years after Da y 1 c ycle 1 f or eac h patie nt.  It ca n be c o n d ucte d b y
tele p h o ne or e mail.
3.
C oa g ulati o n, he mat ol o g y a n d ser u m c he mistr y (li mite d t o t otal bilir u bi n, al kali ne p h os p hatase, A L T, A S T, G G T, L D H a n d al b u mi n) re q uire d f or o ne year after C ycle 1 
Da y 1 or u ntil ne w a nti-ca ncer treat me nt, w hic he ver occ urs first.  F or patie nts i n disease f oll o w u p be y o n d a ye ar fr o m C ycle 1 Da y 1, C B C wit h
differe ntial a n d platelets
re q uire d u ntil disease pr o gressi o n.
4.
B o ne marr o w as pirate a n d e xtra me d ullar y disease assess me nts. Perf or me d e ver y 1 2 wee ks (1 wee k) f or 1 year fr o m C y cle 1 Da y 1, a n d e ver y 2 4 wee ks ( ± 2 wee ks)
bet wee n year 1 a n d 2, a n d w he ne ver cli nicall y i n dicate d. Disease assess me nts i ncl u de li ver a n d s plee n assess me nts. N o b o ne marr o w as pirate is necessar y if n o n- res p o nse or
pr o gressi ve disease/rela pse ca n b e dia g n ose d fr o m peri p heral bl o o d e val uati o n.
5.
T o i ncl u de a ntica ncer me dicati o ns, ca ncer-relate d ra di ot hera p y, a n d ca ncer-relate d s ur gical t hera pies.  Start/st o p date will be c ollecte d f or 2 years (t otal, relati ve t o t he da y 
of e nr oll me nt).  Als o at least t he first p ost -st u d y sal va ge t hera p y (re-i n d ucti o n) a n d res p o nse t o t he first p ost st u d y sal va ge t hera p y (re-i n d ucti o n) will be re p orte d i n t he 
C R F (refract or y or res p o nsi ve d isease).  P ost-st u d y tra ns pla nt i nf or mati o n i ncl u di n g c o n diti o ni n g treat me nts will be c ollecte d f or u p t o 2 years fr o m e nr oll me nt.  Select 
c o nc o mita nt me dicati o ns i ncl u di n g a ntif u n gals, pr o p h yla xis/treat me nt f or graft vs h ost disease, a n d pr o p h yla xis/treatme nt f or V O D will be c ollecte d f or u p t o at least 
1 0 0 da ys after H S C T.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 5
P K sa m ples will be c ollecte d f or all patie nts a n d E C G i n tri plicate will be d o ne f or all patie nts.
T a ble 3 . 
P h ar m ac o ki netics a n d E C G M o nit ori n g Fl o wc h art
C ycle 1
C ycle D a y
1
4
8
1 5
Ti me ( h) relati ve t o t he start of i n ot uz u ma b
oz o ga mici n a d mi nistrati o n
0
1
2
4
7 2
0
1
6
0
1
P K sa m ple c ollecti o n a
X b
X c
X  
X
X
X b
X c
X  
X b
X c
E C Gs d
X  
X
C ycle 2
C ycle D a y
1
8
Ti me ( h) relati ve t o t he start of i n ot uz u ma b
oz o ga mici n a d mi nistrati o n
0
1
2
0
2
P K sa m ple c ollecti o n a
X b
X c
X
X b
X
E C Gs d
X  
X
C ycle 4
C ycle D a y
1
8
Ti me ( h) relati ve t o t he start of i n ot uz u ma b
oz o ga mici n a d mi nistrati o n
0
1
0
P K sa m ple c ollecti o n a
X b
X c
X b
E C Gs d
X
X
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 6
T a ble 3 . 
P h ar m ac o ki netics a n d E C G M o nit ori n g Fl o wc h art
A b bre viati o ns. h = h o ur; P K = p har mac o ki netics; E C G =electr ocar di o gra m
a.
P K sa m ples: C o ns ult t he la b orat or y ma n ual f or v ol u me of bl o o d nee de d a n d sa m ple pre parati o n.  T o a v oi d c o nta mi nati o n, sa m ples m ust n ot be ta ke n fr o m t he sa me 
l u me n t hat is use d f or dr u g i nf usi o n.  O nl y i n e xte n uati n g circ u msta nces ma y t he P K sa m ple(s) be collecte d fr o m t he sa me l u me n.  If t he sa me l u me n has bee n use d f or a 
P K sa m ple c ollecti o n it m ust be d oc u me nte d i n t he C R F.  T he act ual ti mes ma y c ha n ge, b ut t he n u m ber of sa m ples will re mai n t he sa me.  All eff orts will be ma de t o 
o btai n t he sa m ples at t he e xact n o mi nal ti me relati ve t o d osi n g.  C ollecti o n of sa m ples u p t o a n d i ncl u di n g 1 0 h o urs after d ose a d mi nistrati o n t hat are o btai ne d wit hi n 
1 0 % of t he n o mi nal ti me (e g, wit hi n 6 mi n utes of a 6 0 - mi n ute sa m ple) relati ve t o d osi n g will n ot be ca pt ure d as a pr ot oc ol de viati o n, as l o n g as t he e xact ti me of t he 
c ollecti o n is n ote d o n t he s o urce d oc u me nt a n d data c ollecti o n t o ol (e g, C R F).
C ollecti o n of sa m ples m ore t ha n 1 0 h o urs after d ose a d mi nistrati o n t hat are o btai ne d 
≤1 h o ur a wa y fr o m t he n o mi nal ti me re lati ve t o d osi n g will n ot be ca pt ure d as a pr ot oc ol de viati o n, as l o n g as t he e xact ti me of t he c ollecti o n is n ote d o n t he s ource 
d oc u me nt a n d data c ollecti o n t o ol (e g, C R F). 
b.
Sa m ple t o be dra w n bef ore t he start of i n ot uz u ma b oz o ga mici n i nf usi o n.
c.
Sa m ple t o be dra w n i m me diatel y bef ore e n d of i n ot uz u ma b oz o ga mici n i nf usi o n.
d.
Electr ocar di o gra ms ( E C Gs) are c ollecte d i n tri plicate ( 3 c o nsec uti ve E C Gs a p pr o xi matel y 2 mi n utes a part) a n d will be d o ne i m m e diatel y ( wit hi n 1 5 mi n utes) bef ore eac h 
c orres p o n di n g P K sa m pl e c ollecti o n.  Pre d ose E C Gs t o be perf or me d after pre me dicati o ns a n d bef ore t he start of dr u g i nf usi o n.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 7
2. I N T R O D U C TI O N
2. 1. St u d y R ati o n ale 
T his is a P hase 4 , o pe n -la bel, si n gle-ar m, m ultice nter st u d y i n C hi nese patie nts wit h rela pse d 
or refract or y C D 2 2 -p ositi ve B -cell A L L. T his st u d y  is a p ost a p pr o val c o m mit me nt st u d y t o 
c o nfir m t he efficac y, safet y, a n d P K of i n ot uz u ma b oz o ga mici n i n patie nts wit h rela pse d or 
refract or y B-cell A L L fr o m mai nla n d C hi na.
2. 2. B ac k gr o u n d 
O ver 5 3 0 0 ne w A L L patie nts > 1 8 ye ars are dia g n ose d a n n uall y i n t he U S, wit h > 9 0 % of
B cell A L L patie nts e x pressi n g C D 2 2. 1 ,2  Si milar n u m bers of A L L patie nts are dia g n ose d
a n n uall y i n t he E ur o pea n U ni o n ( E U) wit h a n a n n ual i nci de nce of 1. 3 per 1 0 0, 0 0 0 
i n di vi d uals.3  I n C hi na, t he i nci de nce rate of A L L is si milar t o U S a n d E U wit h a rate of 
1. 5 per 1 0 0, 0 0 0 i n di vi d uals f or males a n d 1. 2 per 1 0 0, 0 0 0 i n di vi d uals f or fe males. 4
Treat me nt of rela pse d or refract or y  P h- B-cell A L L t y picall y i ncl u des a variet y of i n d ucti o n 
re gi me ns (ie, t here is n o si n gle sta n dar d of care).  Acce pta ble re gi me ns ca n i ncl u de i n ducti o n 
t hera pies base d o n a bac k b o ne of vi ncristi ne, c ortic oster oi ds, a n d a nt hrac ycli nes, h y per
c ycl o p h os p ha mi de, vi ncristi ne, a dria m y ci n-, a n d de xa met has o ne ( hy per -C V A D ), c ytara bi ne-
base d ( Ara - C) re gi me ns s uc h as hi g h-d ose Ara -C ( HI D A C), fl u dara bi ne pl us Ara -C pl us 
gra n ul oc y te-c ol o n y sti m ulati n g fact or ( F L A G) ±i dar u bici n, met h otre xate base d re gi me ns, 
H S C T, a n d ot her c he m ot hera p y re gi me ns. 1 6
All t hese a ge nts are c o nsi dere d t o ha ve li mite d treat me nt be nefits i n t he rela pse d or refract or y  
A L L setti n g a n d carr y  si g nifica nt t o xicit y ris ks wit h t he vast maj orit y of patie nts n ot 
ac hie vi n g l o n g -ter m s ur vi val. C o m plete res p o nse rates i n t he fr o nt-li ne setti n g ca n ra n ge 
fr o m 8 0 % t o 9 0 %; h o we ver, o nl y a p pr o xi matel y 3 0 – 4 0 % of a d ults ac hie ve l o n g-ter m
disease -free s ur vi val ( D F S), wit h t he pri mar y reas o n f or fail ure bei n g disease rec urre nce.5  
Des pite t he ass ociate d m ortalit y a n d m or bi dit y , all o ge neic he mat o p oietic cell tra ns pla ntati o n 
after sal va ge t hera p y offers t he best o p p ort u nit y f or l o n g-ter m s ur vi val i n patie nts wit h a 
s uita ble d o n or a n d a res p o nse t o sal va ge t hera p y.  H o we ver, t he pr o g n osis f or t hese patie nts 
re mai ns p o or wit h o nl y 3 0 % e x pecte d t o ha ve a c o m plete res p o nse after 1 st sal va ge t hera p y 
wit h a me dia n o verall s ur vi val ( O S) of a p pr o xi matel y 5 m o nt hs a n d wit h o nl y a q uarter of 
patie nts ali ve at 1 year. 6  C o m plete res p o nses a n d pr o g n osis are e ve n p o orer i n t he sec o n d 
a n d t hir d sal va ge setti n g.  A retr os pecti ve re vie w of 2 8 8 sec o n d sal va ge patie nts treate d at a 
si n gle i nstit uti o n was n ota ble f or a C R rate of 1 8 %, a me dia n C R d urati o n of 7 m o nt hs, a n d a
me dia n o verall s ur vi val of
o nl y 3 m o nt hs. 7  W hile all o ge neic tra ns pla nt is sta n dar d
i n t he 
sal va ge setti n g, a si g nifica nt n u m ber of patie nts d o n ot ha ve a s uita ble d o n or, or t heir a ge or
ot he r c o m or bi dities precl u de t his o pti o n.  A p pr o xi matel y o ne q uarter of a d ult A L L patie nts 
are ol der t ha n 6 0 years of a ge, wit h t hese ol der patie nts ha vi n g w orse o utc o mes wit h me dia n 
o verall s ur vi val ( O S) d urati o ns ra n gi n g fr o m 3 – 1 4 m o nt hs. 8  F urt her m ore, patie nts wit h
P hila del p hia c hr o m os o me -p ositi ve A L L a n d ot her hi g h -ris k c yt o ge netic a b n or malities d o
m ore p o orl y , wit h 3 – 5 year s D F S rates
of < 1 0 %. 5
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 8
A p pr o ve d t hera pies f or t he treat me nt of rela pse d A L L i ncl u de Cl ofara bi ne ( Cl olar/ El v oltra® ),
Dasati ni b ( S pr ycel ® ) a n d I mati ni b is c urre ntl y a p pr o ve d f or rela pse d pe diatric A L L patie nts 
i n t he U nite d States a n d E U.  A p pr o val of cl ofara bi ne was base d o n t he res ults of a p hase 2 
st u d y i n refract or y/rela pse d A L L ( b ot h B a n d T cell A L L) s h o wi n g a
c o m plete re missi o n rate 
( C R + C R p) of 2 0 % a n d a n o verall res p onse rate (i ncl u di n g C R, C R p, a n d partial res p o nse 
[ P R]) of 3 0 % i n 6 1 pe diatric patie nts. 9  Dasati ni b a n d i mati ni b are als o a p pr o ve d f or a d ult
patie nts wit h rela pse d or refract or y P hila del p hia -c hr o m os o me p ositi ve A L L w orl d wi de
i ncl u di n g Ja pa n.1 0 F or patie nts wit h P h - B-cell A L L, m ore rece nt U S F D A -a p pr o ve d 
treat me nt a p pr oac hes i ncl u de: Tisa ge nlecle ucel, a C D 1 9-directe d ge neticall y  m o difie d 
a ut ol o g o us T -cell i m m u n ot hera p y was gra nte d re g ular a p pr o val b y F D A i n A u g ust 2 0 1 7 f or 
t he treat me nt of patie nts u p t o 2 5 years of a ge wit h B-cell prec urs or A L L t h at is refract or y or 
i n sec o n d or later rela pse.1 7 Bli nat u m o ma b, a bis pecific a nti -C D 3/ C D 1 9 m o n ocl o nal 
a nti b o d y, was gra nte d accelerate d a p pr o val b y the F D A i n 2 0 1 4 f or t he treat me nt of 
P h - patie nts wit h rela pse d or refract or y  B-cell prec urs or A L L a n d was gra nte d f ull a p pr o val 
b y  F D A i n J ul y 2 0 1 7 f or t he treat me nt of rela pse d or refract or y B-cell prec urs or i n a d ults a n d 
c hil dre n; f ull a p pr o val i ncl u de d treat me nt of P h + patie nts. I n Marc h 2 0 1 8, bli nat u m o ma b was 
gra nte d accelerate d a p pr o val f or t he treat me nt of B -cell prec urs or ( A L L) i n first or sec o n d C R 
w it h M R D ≥0. 1 % i n a d ults a n d c hil dre n .1 8 Li p os o mal vi ncristi ne was gra nte d accelerate d 
a p pr o val b y t he F D A i n 2 0 1 2 f or treat me nt of patie nts i n sec o n d or later sal va ge.1 9
T heref ore, t here is a si g nifica nt p o p ulati o n of pe diatric a n d a d ult patie nts wit h
rela pse d/refract or y A L L i n w hic h c urre nt t hera pies are s u b o pti mal i n ter ms of re missi o n
i n d ucti o n a n d d ura bilit y of re missi o n.
I not uz u ma b oz o ga mici n, a n a nti b o d y tar geti n g C D 2 2 a n d c o nj u gate d wit h a c yt ot o xic
a ntit u m or a nti bi otic (calic hea mici n), has bee n e val uate d as a si n gle a ge nt or i n c o m bi nati o n
wit h rit u xi ma b i n p hase 1/ 2 st u dies i n rela pse d/refract or y C D 2 2 -p ositi ve n o n -H o d g ki n’s 
l ym p h o ma (N H L).   Si g nifica nt cli nical acti vit y has bee n n ote d at d oses starti n g at 0. 8 m g/ m 2
e ver y 3 wee ks wit h o bjecti ve res p o nses o bser ve d acr oss all d osi n g c o h orts a n d m ulti ple N H L
s u bt ypes. 1 1  I n t hese i nitial st u dies, t he ma xi m u m t olerate d d ose of i n ot uz u ma b oz o ga mici n 
gi ve n al o ne or i n c o m bi nati o n wit h rit u xi ma b i n o ver 3 0 0 patie nts, was i de ntifie d at 
1. 8 m g/ m 2 e ver y 4 wee ks.
Ac ute l ym p h oc y tic le u ke mia w o ul d be e x pecte d t o be a g o o d t hera pe utic tar get f or
i n ot uz u ma b oz o ga mici n d ue t o C D 2 2 p ositi vit y o n B cell l ym p h o blasts, a n d prese nce of t he
tar get i n t he s yste mic circ ulati o n. I n part, s o me of t he t he oretical c o ncer ns re gar di n g access
of a n a nti b o d y c o nj u gate t o pe netrate i nt o lar ge b ul k y s oli d t u m or are miti gate d.
2. 2. 1. I n ot uz u m a b Oz o g a mici n 
I n ot uz u ma b oz o ga mici n is a C D 2 2 directe d a nti b o d y dr u g c o nj u gate ( A D C) c o nsisti n g of 
3 c o m p o ne nts: 1) t he rec o m bi na nt h u ma nize d i m m u n o gl o b uli n clas s G s u bt ype 4 (I g G 4) 
ka p pa a nti b o d y i n ot uz u ma b, s pecific f or h u ma n C D 2 2, 2) N -acet yl  ga m ma calic hea mici n 
t hat ca uses d o u ble stra n de d de o x yri b o n ucleic aci d ( D N A) brea ks, a n d 3) a n aci d clea va ble 
li n ker c o m p ose d of t he c o n de nsati o n pr o d uct of 4 ( 4-acet yl p he n o x y ) b uta n oic aci d ( Ac B ut) 
a n d 3-met h y l- 3-merca pt o b uta ne h y drazi de ( k n o w n as di met h y l h ydrazi de) t hat c o vale ntl y 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 2 9
attac hes N -acet yl  ga m ma calic hea mici n t o i n ot uz u ma b.  N o ncli nical data s u g gest t hat t he 
a ntica ncer acti vit y of i n ot uz u ma b oz o ga mici n is d ue t o the bi n di n g of t he A D C t o C D 2 2 
e x pressi n g t u m or cells, f oll o we d b y  i nter nalizati o n of t he A D C C D 2 2 c o m ple x, a n d t he 
i ntracell ular release of N-acet yl  ga m ma calic hea mici n di met h yl h ydrazi de via h y dr ol yt ic 
clea va ge of t he li n ker 1.  Acti vati o n of N- acet yl  ga m ma calic hea mici n di met h yl h ydrazi de 
i n d uces d o u ble stra n d D N A brea ks, s u bse q ue ntly i n d uci n g cell c ycle arrest a n d a p o pt otic cell 
deat h. 
I n ot uz u ma b oz o ga mici n ( B E S P O N S A® ) is c urre ntl y a p pr o ve d i n t he U nite d States ( U S), t he 
E ur o pea n U ni o n ( E U), S witzerla n d (a p pr o vals gra nte d i n 2 0 1 7), a n d Ja pa n (a p pr o val gra nte d 
i n 2 0 1 8), a n d C hi na (a p pr o val gra nte d i n 2 0 2 1).  A p pr o val was base d o n de m o nstrati o n of a 
p ositi ve be nefit/ris k f or t he treat me nt of a d ults wit h rela pse d or refract or y  B cell prec urs or 
A L L.  T he a p pr o v e d d osi n g re gi me n is a starti n g d ose of 1. 8 m g/ m 2 per c y cle (a d mi nistere d 
as 3 di vi de d d oses o n Da y 1 [ 0. 8 m g/ m 2], Da y 8 [ 0. 5 m g/ m2], a n d Da y 1 5 [ 0. 5 m g/ m2]) 
w hic h is re d uce d t o 1. 5 m g/ m 2 per c y cle (a d mi nistere d as 3 di vi de d d oses o n 0. 5 m g/ m 2 o n 
D a y  1, 8, a n d 1 5) o nce c o m plete re missi o n ( C R) or c o m plete re missi o n wit h i nc o m plete 
he mat ol o gic rec o ver y  ( C Ri) is ac hie ve d.  Cycle 1 is 3 wee ks i n d urati o n, b ut ma y  be 
e xte n de d t o 4 wee ks if t he patie nt ac hie ves a C R/ C Ri, a n d/ or t o all o w rec o ver y  fr o m t o xicit y.  
S u bse q ue nt c y cles are 4 wee ks i n d urati o n.  F or patie nts pr ocee di n g t o he mat o p oietic ste m 
cell tra ns pla ntati o n ( H S C T), t he rec o m me n de d treat me nt is 2 c ycles.  A t hir d c ycle ma y be 
c o nsi dere d f or t h ose patie nts w h o d o n ot ac hie ve C R/ C Ri a n d M R D ne gati vit y  after 2 c ycles.  
F or patie nts n ot pr ocee di n g t o H S C T, u p t o a ma xi m u m of 6 c ycles ma y be a d mi nistere d.
2. 2. 2. Cli nic al O ver vie w
2. 2. 2. 1. P h ase 3 St u d y B 1 9 3 1 0 2 2
2. 2. 2. 1. 1. Effic ac y
T he acti vit y  of t he c urre ntl y a p pr o ve d i n ot uz u ma b oz o ga mici n d osi n g re gi me n was 
de m o nstrate d i n a ra n d o mize d ( 1: 1), o pe n -la bel, i nter nati o nal P hase 3 st u d y  ( B 1 9 3 1 0 2 2).  
St u d y B 1 9 3 1 0 2 2 c o m pare d i n ot uz u ma b oz o ga mici n - t o In vesti gat or’s c h oice of 
c he m ot hera p y (c o ntr ol) as Sal va ge 1 or 2 t hera p y i n a d ults wit h rela pse d or refract or y C D 2 2
p ositi ve B -cell A L L.  I n vesti gat or’s c h oice of c he m ot hera py was fl u dara bi ne + c ytara bi ne + 
gra n ul oc y te c ol o ny sti m ulati n g fact or ( F L A G), hi g h -d ose c ytara bi ne ( HI D A C), or 
mit o xa ntr o ne + c ytara bi ne ( M X N/ Ara- C).  Patie nts wit h P h + disease m ust ha ve faile d 
treat me nt wit h at least 1 t yr osi ne ki nase i n hi bit or ( T KI) a n d sta n dar d c he m ot hera p y.  Patie nts 
were stratifie d at ra n d o mizati o n base d o n d urati o n of first re missi o n ( < 1 2 vs 1 2 m o nt hs), 
li ne of sal va ge ( Sal va ge 1 vs 2), a n d a ge ( < 5 5 vs 5 5 ye ars). 1 2 ,1 3
T he st u d y  ha d 2 pri mar y  e n d p oi nts: he mat ol o gic re missi o n ( C R/ C Ri, e val uate d base d o n t he 
first 2 1 8 patie nts ra n d o mize d (i nte nt -t o-treat (I T T) 2 1 8 p o p ulati o n), per E n d p oi nt 
A dj u dicati o n C o m mittee assess me nt) a n d o verall s ur vi val ( O S; base d o n all 3 2 6 ra n d o mize d 
patie nts).  T he sec o n dar y efficac y  e n d p oi nts i ncl u de d M R D ne gati vit y ( defi ne d as 
< 1 a b n or mal cell/ 1 0 4 n ucleate d cells b y  fl o w c yt o metr y per ce ntral la b orat or y a nalys is), 
d urati o n of re missi o n ( D o R), pr o gressi o n -free s urvi val ( P F S), a n d H S C T rate. 1 2 ,1 3
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 0
T he st u d y  met t he pri mar y o bjecti ve of C R/ C Ri, wit h rates of 8 0. 7 % vs 2 9. 4 % f or t he 
i n ot uz u ma b oz o ga mici n a n d c o ntr ol ar ms, res pecti vel y ( p-val ue < 0. 0 0 0 1 ) (Ta ble 4 ).  A m o n g 
res p o n ders i n t he I T T 2 1 8 p o p ulati o n, M R D ne gati vit y was hi g her a n d D o R was l o n ger f or 
t he i n ot uz u ma b oz o ga mici n ar m c o m pare d t o t he c o ntr ol ar m ( M R D ne gati vit y, 7 8. 4 % vs 
2 8. 1 %, res pecti vel y ; me dia n D o R, 5. 4 m o nt hs vs 3. 5 m o nt hs, res pecti vel y, Ta ble 4 ).  
Re missi o n, D o R, a n d M R D ne gati vit y  res ults i n all 3 2 6 ra n d o mize d patie nts were c o nsiste nt 
wit h t h ose f or t he first 2 1 8 ra n d o mize d patie nts (Ta ble 4 ).1 2 ,1 3
T a ble 4 . 
St u d y B 1 9 3 1 0 2 2: Effic ac y Fi n di n gs f or C R/ C Ri, D o R a n d M R D Ne g ati vit y
First 2 1 8 P atie nts R a n d o mize d 1
All 3 2 6 P atie n ts R a n d o mize d2
I n ot uz u m a b 
Oz o g a m ici n 
( N = 1 0 9)
C o ntr ol: HI D A C, 
F L A G, or 
M X N/ Ar a -C 
( N = 1 0 9)
I n ot uz u m a b 
Oz o g a m ici n 
( N = 1 6 4)
C o ntr ol: HI D A C, 
F L A G, or 
M X N/ Ar a -C 
( N = 1 6 2)
Res p o n di n g ( C R/ C Ri) p atie nts
n ( %) 
[ 9 5 % CI]
8 8 ( 8 0. 7)
[ 7 2. 1 8 7. 7]
3 2 ( 2 9. 4)
[ 2 1. 0 3 8. 8]
1 2 0 ( 7 3. 2)
[ 6 5. 7 7 9. 8]
5 0 ( 3 0. 9)
[ 2 3. 9 3 8. 6]
p -val ue 3
< 0. 0 0 0 1 ( pri mar y e n d p oi nt)
< 0. 0 0 0 1
D o R i n res p o n di n g ( C R/ C Ri) p atie nts 4
N
8 4
3 2
1 2 0
5 0
Me dia n, m o nt hs
[ 9 5 % CI]
5. 4
[ 4. 2-8. 0]
3. 5
[ 2. 9-6. 6]
5. 3
[ 4. 2-7. 0]
3. 6 
[ 2. 9-5. 2]
p val ue 3
0. 0 0 3 1
0. 0 0 5 2
M R D ne g ati vit y i n res p o n di n g ( C R/ C Ri) p atie nts
5
N
6 9
9
9 2
1 9
Rate 6( %)
[ 9 5 % CI]
6 9/ 8 8 ( 7 8. 4)
[ 6 8. 4-8 6. 5]
9/ 3 2 ( 2 8. 1)
[1 3. 7 -4 6. 7]
9 2/ 1 2 0 ( 7 6. 7)
[ 6 8. 1-8 3. 9]
1 9/ 5 0 ( 3 8. 0)
[ 2 4. 7-5 2. 8]
p -val ue
< 0. 0 0 0 1
< 0. 0 0 0 1
A b bre viati o ns: CI =c o nfi de nce i nter val; C R =c o m plete re missi o n; C Ri =c o m plete re missi o n wit h i nc o m plete he mat ol o gic 
rec o ver y; D o R = d urati o n of re missi o n; E A C = E n d p oi nt A dj u dicati o n C o m mittee; F L A G =fl u dara bi ne + c ytara bi ne + 
gra n ul oc yte c ol o n y -sti m ulati n g fact or; HI D A C = hi g h-d ose c ytara bi ne; M R D = mi ni mal resi d ual disease; M X N/ Ara -
C = mit o xa ntr o ne + c ytara bi ne; N/ n = n u m ber of patie nts; P F S = pr o gressi o n free s ur vi val.
1.
C R/ C Ri per E A C assess me nt.  C R was defi ne d as < 5 % blasts i n t he b o ne marr o w a n d t he a bse nce of peri p heral 
bl o o d le u ke mic blasts, f ull rec o ver y of peri p heral bl o o d c o u nts ( platelets ≥1 0 0 × 1 0 9/ L a n d a bs ol ute ne utr o p hil 
c o u nts [ A N C] ≥1 × 1 0 9/ L) a n d res ol uti o n of a n y e xtra me d ullar y disease.  C Ri was defi ne d as < 5 % blasts i n t he 
b o ne marr o w a n d t he a bse nce of peri p heral bl o o d le u ke mic blasts, i nc o m plet e rec o ver y of peri p heral bl o o d c o u nts 
( platelets < 1 0 0 × 1 0 9/ L a n d/ or A N C < 1 × 1 0 9/ L) a n d res ol uti o n of a n y e xtra me d ullar y disease.  C R/ C Ri a n d M R D 
ne gati vit y res ults fr o m pla n ne d i nteri m a nal ysis ( data c ut off date 0 2 Oct o ber 2 0 1 4).
2.
C R/ C Ri per I n vesti gat or’ s assess me nt.  Data c ut off date 0 8 Marc h 2 0 1 6.
3.
1- si de d p- val ue usi n g C hi-s q uare d test or Fis her’s e xact test (if a n y C hi-s q uare d cell c o u nt < 5).
4.
D o R, base d o n a later c ut off date t ha n t he C R/ C Ri ( data c ut off date 0 8 Marc h 2 0 1 6), was defi ne d f or patie nts w h o 
ac hie ve d C R/ C Ri per I n vesti gat or’s assess me nt as ti me si nce first res p o nse of C R/ C Ri per I n vesti gat or’s assess me nt 
t o t he date of a P F S e ve nt or ce ns ori n g date if n o P F S e ve nt was d oc u me nte d.
5.
M R D ne gati vit y was defi ne d b y fl o w c yt o metr y
as le u ke mic cells c o m prisi n g < 1 × 1 0 - 4 ( < 0. 0 1 %) of b o ne marr o w 
n ucleate d cells.
6.
Rate was defi ne d as t he n u m ber of patie nts w h o ac hie ve d M R D ne gati vit y di vi de d b y t he t otal n u m ber of patie nts 
w h o ac hie ve d C R/ C Ri per E A C (first 2 1 8 ra n d o mize d patie nts) or per I n vesti gat or as sess me nt (all 3 2 6 ra n d o mize d 
patie nts).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 1
I n all ra n d o mize d patie nts ( N = 3 2 6) at st u d y c o m pleti o n (last patie nt last visit), t he esti mate d 
hazar d rati o ( H R) f or P F S was 0. 4 5 0 ( 9 5 % c o nfi de nce i nter val [ CI]: 0. 3 3 6- 0. 6 0 2) wit h 
1 -si de d p < 0. 0 0 0 1 i n fa v or of in ot uz u ma b oz o ga mici n o ver c o ntr ol base d o n a stratifie d 
a nal ys is.
O verall, 7 9/ 1 6 4 patie nts ( 4 8 %) i n t he i n ot uz u ma b oz o ga mici n ar m a n d 3 5/ 1 6 2 patie nts 
( 2 2 %) i n t he c o ntr ol ar m ha d a f oll o w-u p H S C T. 1 3  A m o n g t he 7 9 patie nts i n t he i n ot uz u ma b 
oz o ga mici n ar m w h o u n der we nt a f oll o w -u p H S C T, 7 1 patie nts pr ocee de d t o H S C T directl y  
after i n ot uz u ma b oz o ga mici n - treat me nt ( wit h o ut a n y i nter ve ni n g i n d ucti o n t herap y ) wit h a 
me dia n ga p of 4. 9 wee ks (ra n ge: 1 - 1 9 wee ks) bet wee n t he last d ose of i n ot uz u ma b 
oz o ga mici n - a n d H S C T.  
T he ot her pri mar y  o bjecti ve of t he st u d y was t o c o m pare O S bet wee n t he 2 treat me nt ar ms.  
T o pr otect t he t y pe I err or, al p ha was split bet wee n t he t w o pri mar y  e n d p oi nt C R/ CR i rate 
per E n d p oi nt A dj u dicati o n C o m mittee ( E A C) a n d O S.  At t he fi nal a nal ys is of O S base d o n 
data c ut off date of 0 8 Marc h 2 0 1 6, t he esti mate d H R (i n ot uz u ma b oz o ga mici n vs t he 
I n vesti gat or’s c h oice of c he m ot hera py ar m ) was 0. 7 7 0 ( 9 7. 5 % CI: 0. 5 7 8-1. 0 2 6; 1 -si de d 
p = 0. 0 2 0 3) base d o n t he stratifie d a nal ys is, i n dicati n g a n o verall 2 3 % re d ucti o n i n t he ris k of 
deat h i n fa v or of i n ot uz u ma b oz o ga mici n.  T heref ore, t here was a cli nicall y  mea ni n gf ul tre n d 
t o war ds i m pr o ve d O S i n the i n ot uz u ma b oz o ga mici n ar m c o m pare d wit h t he I n vesti gat or’s 
c h oice of c he m ot hera p y ar m, b ut t his di d n ot reac h pres pecifie d statistical si g nifica nce at a 1-
si de d si g nifica nce le vel of 0. 0 1 0 4 d ue t o t he s plit al p ha desi g n a n d al p ha s pe n di n g at t he 
2 i nteri m a nal yses.  At st u d y c o m pleti o n (last patie nt last visit), t he esti mate d H R f or O S was 
0. 7 5 ( 9 7. 5 % CI : 0. 5 7-0. 9 9, 1 si de d p -val ue 0. 0 1 0 5) ( Fi g ure 1 ).1 3
Fi g ure 1 .
St u d y B 1 9 3 1 0 2 2: K a pl a n Meier C ur ve f or O ver all S ur vi v al (I nte nt t o Tre at 
P o p ul ati o n)
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 2
2. 2. 2. 1. 2. P h ar m ac o ki netic
Base d o n P K data fr o m 1 6 3 patie nts i n St u d y B 1 9 3 1 0 2 2, mea n pea k a n d tr o u g h e x p os ures of 
i n ot uz u ma b oz o ga mici n i ncrease d wit h eac h c ycle, d ue t o its l o n g stea d y state eli mi nati o n 
half life ( 1 2. 3 d a y s).  Mea n pea k c o nce ntrati o ns i n ser u m were o bser ve d at or near t he en d of 
i nf usi o n wit h a hi g hest o bser ve d mea n pea k c o nce ntrati o n of 3 0 8 n g/ m L  b y C ycle 4 Da y 1 
a n d t he hi g hest o bser ve d mea n tr o u g h c o nce ntrati o n of 9 1. 3 n g/ m L, b y C ycl e 4 Da y 8, 
c o m pare d t o a pea k of 2 1 1 n g/ m L at C ycle 1 Da y 1 a n d a tr o u g h of 6. 8 4 n g/ m L  at C y cle 1 
D a y 8.
Base d o n t he e x p os ure res p o nse a nalys es of t he safet y a n d efficac y data fr o m P hase 3 
St u d y B 1 9 3 1 0 2 2 a n d P hase 1/ 2 St u d y  B 1 9 3 1 0 1 0, t here was a statistically si g nifica nt 
( p < 0. 0 0 0 1) relati o ns hi p bet wee n i n ot uz u ma b oz o ga mici n a vera ge ser u m c o ncentrati o n u p t o 
t he ti me of res p o nse ( Ca v g) a n d t he pr o ba bilit y of C R/ C Ri a n d M R D ne gati vit y.  F urt her m ore, 
t here was a statisticall y si g nifica nt ( p < 0. 0 5) relati o ns hi p bet wee n i n ot uz u ma b oz o ga mici n 
c u m ulati ve t otal ser u m e x p os ure d uri n g C y cle 1 (c A U C P 1 ) a n d t he pr o ba bilit y of V O D ( V O D 
per assess me nt of t he i n de pe n de nt He patic E ve nts A dj u dicati o n B oar d ( H E A B) f or P hase 3 
St u d y B 1 9 3 1 0 2 2).
2. 2. 2. 1. 3. S afet y
I n St u dy B 1 9 3 1 0 2 2, 1 6 4 patie nts recei ve d i n ot uz u ma b oz o ga mici n.  T he me dia n d urati o n of 
treat me nt was 8. 9 wee ks (ra n ge: 0. 1- 2 6. 4 wee ks), wit h a me dia n of 3 treat me nt c ycles starte d 
i n eac h patie nt.  T he m ost c o m m o n (2 %) seri o us a d verse e ve nts re p orte d f or patie nts w h o 
recei ve d i n ot uz u ma b oz o ga mici n were i nfecti o n, fe brile ne utr o pe nia, he m orr ha ge, a b d o mi nal 
pai n, p y re xia, fati g ue, a n d V O D. 1 3
2. 2. 2. 1. 3. 1. He p at ot o xicit y, I ncl u di n g Ve n o- occl usi ve Dise ase ( V O D; als o k n o w n as 
si n us oi d al o bstr ucti o n s y n dr o me) 
He pat ot o xicit y, i ncl u di n g se vere, life -t hreate ni n g, a n d s o meti mes fatal he patic V O D was 
o bser ve d i n 2 3/ 1 6 4 patie nts ( 1 4 %) d uri n g or f oll o wi n g i n ot uz u ma b oz o ga mici n.  As 
descri be d bel o w, m ost cases of V O D occ urre d after s u bse q ue nt H S C T (f oll o wi n g c o m pleti o n 
of i n ot uz u ma b oz o ga mic i n treat me nt).1 3
V O D was re p orte d i n 5/ 1 6 4 patie nts ( 3 %) d uri n g st u d y  t hera p y or i n f oll o w- u p wit h o ut a n 
i nter ve ni n g H S C T.  F or t hese 5 patie nts, V O D was re p orte d u p t o 5 6 d a y s after t he last d ose 
of i n ot uz u ma b oz o ga mici n. 1 3
A m o n g t he 7 9 i n ot uz u ma b oz o ga mici n treate d patie nts w h o pr ocee de d t o a s u bse q ue nt 
H S C T, V O D was re p orte d i n 1 8/ 7 9 patie nts ( 2 3 %).  T he me dia n ti me fr o m s u bse q ue nt H S C T 
t o o nset of V O D was 1 5 da y s (ra n ge: 3 - 5 7 d a y s).  Fi ve ( 5) cases of V O D p ost-H S C T were 
fatal.1 3  W hile V O D is a t o xicit y  k n o w n t o be ass ociate d wit h t he he pat ot o xic c o n diti o ni n g 
re gi me ns use d i n H S C T,1 4 t he fre q ue nc y of V O D p ost -H S C T was hi g her i n t he i n ot uz u ma b 
oz o ga mici n ar m c o m pare d t o t he c o ntr ol ar m ( 2 3 % vs 3/ 3 4 [ 9 %] patie nts, res pecti vely). 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 3
T he ris k of V O D was greater i n patie nts w h o u n der we nt H S C T after B E S P O N S A treat me nt; 
use of H S C T c o n diti o ni n g re gi me ns c o ntai ni n g 2 al k ylati n g a ge nts (e g, b us ulfa n i n 
c o m bi nati o n wit h ot her al k ylati n g a ge nts) a n d last t otal bilir u bi n le vel greater t ha n or e q ual t o 
t he u p per li mit of n or mal ( U L N) before H S C T are si g nifica ntl y ass ociate d wit h a n i ncrease d 
ris k of V O D.  Ot her ris k fact ors f or V O D i n patie nts treate d wit h B E S P O N S A i ncl u de d 
o n g oi n g or pri or li ver disease, pri or H S C T, i ncrease d a ge, later sal va ge li nes, a n d a greater 
n u m ber of B E S P O N S A tre at me nt c ycles.  Patie nts w h o ha ve e x perie nce d pri or V O D or ha ve 
seri o us o n g oi n g he patic li ver disease (e g, cirr h osis, n o d ular re ge nerati ve h y per plasia, acti ve 
he patitis) are at a n i ncrease d ris k f or w orse ni n g of li ver disease, i ncl u di n g de vel o pi n g V O D, 
f oll o wi n g treat me nt wit h B E S P O N S A.  A m o n g t he 7 9 i n ot uz u ma b oz o ga mici n treate d 
patie nts w h o ha d a s u bse q ue nt H S C T, 1 1 ( 1 3. 9 %) patie nts recei ve d d ual-al k ylati n g 
c o n diti o ni n g re gi me ns i ncl u di n g 5 patie nts w h o recei ve d b us ulfa n a n d t hi ote pa c o ntai ni n g 
re gi me ns, a n d 2 patie nts w h o recei ve d b us ulfa n a n d c y cl o p h os p ha mi de c o ntai ni n g re gi me ns.
Ot her he pat ot o xicit y  re p orte d f or i n ot uz u ma b oz o ga mici n treate d patie nts i ncl u de d a b n or mal 
li ver tests: Gra de 3/ 4 i ncreases i n as partate a mi n otra nsferase ( A S T), ala ni ne a mi n otransferase 
( A L T), a n d t otal bilir u bi n occ urre d i n 7/ 1 6 0 ( 4 %), 7/ 1 6 1 ( 4 %), a n d 8/ 1 6 1 patie nts ( 5 %), 
res pecti vely. 1 3
2. 2. 2. 1. 3. 2. P ost H S C T N o n -Rel a pse M ort alit y
W hil e t he o verall perce nta ge of patie nts s ur vi vi n g after H S C T was si milar i n b ot h ar ms 
( 3 5. 4 % vs 3 4. 3 %), p ost H S C T n o n -rela pse m ortalit y  ( N R M) rate was hi g her i n t he 
i n ot uz u ma b oz o ga mici n- ar m c o m pare d t o t he c o ntr ol ar m ( 3 9 % vs 2 3 %, res pecti vel y, 
Ta ble 5 ). T he m ost c o m m o n ca uses of p ost H S C T N R M f or i n ot uz u ma b oz o ga mici n treate d 
patie nts i ncl u de d V O D a n d i nfecti o ns.  Fi ve ( 5) of t he 1 8 V O D e ve nts t hat occ urre d 
p ost - H S C T were fatal.  A m o n g patie nts wit h o n g oi n g V O D at ti me of deat h, 6 patie nts die d 
d ue t o m ulti or ga n fail ure ( M O F) a n d/ or i nfecti o n ( 3 patie nts die d d ue t o M O F, 2 patie nts 
die d d ue t o i nfecti o n, a n d 1 patie nt die d d ue t o M O F a n d i nfecti o n ).1 3
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 4
T a ble 5 .
St u d y B 1 9 3 1 0 2 2: P ost H S C T N o n Rel a pse M ort alit y R ate b y Ar m
R ate of V O D P ost -H S C T
I n ot uz u m a b oz o g a mici n
( N = 1 6 4)
C o ntr ol
( N = 1 6 2)
N u m ber of patie nts w h o ha d 
f oll o w-u p H S C T
7 9 ( 4 8. 2)
3 5 ( 2 1. 6)
N u m ber of patie nts wit h 
p ost -H S C T n o n -rela pse m ortalit y 
a dj usti n g f or c o m peti n g ris ks a ,b
3 1 ( 3 9. 2)
8 ( 2 2. 9)
Esti mate d m ortalit y rate at e n d of 
D a y 1 0 0 ( 9 5 % CI) 
2 0. 2 5
( 1 2. 1 9, 2 9. 7 7)
5. 7 1
( 0. 9 9, 1 6. 9 3)
Esti mate d m ortalit y rate at e n d of 
M o nt h
1 2 ( 9 5 % CI) 
3 6. 7 1
( 2 6. 1 4, 4 7. 3 1)
1 4. 5 4
( 5. 1 8, 2 8. 4 8)
Patie nts ma y ha ve ha d m ore t ha n 1 re p orte d reas o n f or t he ca use of deat h.  Me d D R A ( v 1 8. 1) c o di n g 
dicti o nar y was a p plie d.
Data c ut off date 0 1 Se pte m ber 2 0 1 6.
A b bre viati o ns: CI =c o nfi de nce i nter val; H S C T = he mat o p oietic ste m cell tra ns pla nt; N = n u m ber of patie nts.
a.
N u m ber of patie nts wit h p ost -tra ns pla nt wa s use d f or perce nt calc ulati o n.
b.
C o m peti n g ris k was defi ne d as rela pse fr o m C R/ C R i after p ost H S C T, or deat h w here mec ha nis m of 
deat h = disease pr o gressi o n/rela pse.  E ve nts t hat occ urre d after c o m peti n g ris k were n ot i ncl u de d i n 
t he calc ulati o n of c u m ulati ve i nci de nce rate.
2. 2. 2. 1. 3. 3. M yel os u p pressi o n
M y el os u p pressi o n was o bser ve d i n patie nts w h o recei ve d i n ot uz u ma b oz o ga mici n.
T hr o m b oc y t o pe nia a n d ne utr o pe nia were re p orte d i n 8 3/ 1 6 4 ( 5 1 %) patie nts a n d 
8 1/ 1 6 4 ( 4 9 %) patie nts, res pecti vel y.  Gra de 3 t hr o m b oc y t o pe nia a n d ne utr o pe nia were 
re p orte d i n 2 3/ 1 6 4 ( 1 4 %) patie nts a n d 3 3/ 1 6 4 ( 2 0 %) patie nts, res pecti vely.   Gra de 4 
t hr o m b oc yt o pe nia a n d ne utr o pe nia were re p orte d i n 4 6/ 1 6 4 ( 2 8 %) patie nts a n d 4 5/ 1 6 4 ( 2 7 %) 
patie nts, res pecti vel y.  Fe brile ne utr o pe nia, w hic h ma y  be life-t hreate ni n g, was re p orte d i n 
4 3/ 1 6 4 ( 2 6 %) patie nts.  F or patie nts w h o were i n C R/ C Ri at t he e n d of treat me nt, t he 
rec o ver y of platelet c o u nts t o > 5 0, 0 0 0/ m m3 was later t ha n 4 5 d a y s after t he last d ose i n 
1 5/ 1 6 4 ( 9 %) patie nts w h o recei ve d i n ot uz u ma b oz o ga mici n a n d 3/ 1 6 2 ( 2 %) patie nts w h o 
recei ve d c o ntr ol t hera py (I n vesti gat or’s c h oice of c he m ot hera py) .1 3
C o m plicati o ns ass ociate d wit h m y el os u p pressi o n (i ncl u di n g i nfecti o ns a n d 
blee di n g/ he m orr ha gic e ve nts) were o bser ve d i n i n ot uz u ma b oz o ga mici n treate d patie nts.  
I nfecti o ns, i ncl u di n g seri o us i nfecti o ns, s o me of w hic h were life-t hreate ni n g or fatal, were 
re p orte d i n 7 9/ 1 6 4 ( 4 8 %) patie nts.  Fatal i nfecti o ns, i ncl u di n g p ne u m o nia, ne utr o pe nic 
se psis, se psis, se ptic s h oc k, a n d pse u d o m o nal se psis, were re p orte d i n 8/ 1 6 4 ( 5 %) patie nts; 
t he fre q ue nc y of fatal i nfecti o ns was t he sa me i n t he c o ntr ol ar m ( 7/ 1 4 3 patie nts, 4. 9 %).  
Bacterial, viral, a n d f u n gal i nfecti o ns were re p orte d. 1 3
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 5
He m orr ha gic e ve nts were re p orte d i n 5 4/ 1 6 4 ( 3 3 %) pat ie nts w h o recei ve d i n ot uz u ma b 
oz o ga mici n.   Gra de 3 or 4 he m orr ha gic e ve nts were re p orte d i n 8/ 1 6 4 ( 5 %) patie nts .  O ne 
Gra de 5 (fatal) he m orr ha gic e ve nt (i ntra -a b d o mi nal he m orr ha ge) was re p orte d i n 1/ 1 6 4 ( 1 %) 
patie nts .  T he m ost c o m m o n he m orr ha gic e ve nt was e pista xis w hic h was re p orte d i n 
2 4/ 1 6 4 ( 1 5 %) patie nts.1 3
2. 2. 2. 1. 3. 4. I nf usi o n Rel ate d Re acti o ns
I nf usi o n relate d reacti o ns were o bser ve d i n patie nts w h o recei ve d i n ot uz u ma b oz o ga mici n.
I nf usi o n relate d reacti o ns (all Gra de 2) were re p orte d i n 4/ 1 6 4 ( 2 %) patie nts (re p orte d 
s ym pt o ms i ncl u de d fe ver, c hills, a n d h y p ote nsi o n).  I nf usi o n relate d reacti o ns ge nerall y 
occ urre d i n C y cle 1 s h ortl y  after t he e n d of t he i n ot uzu ma b oz o ga mici n i nf usi o n a n d res ol ve d 
s p o nta ne o usl y or wit h me dical ma na ge me nt.1 3
2. 2. 2. 1. 3. 5. Q T I nter v al Pr ol o n g ati o n
I ncreases i n Q T i nter val c orrecte d f or hear t rate usi n g Fri dericia’s f or m ula ( Q Tc F) of 
6 0 msec fr o m baseli ne were meas ure d i n 4/ 1 6 2 ( 3 %) patie nts w h o recei ve d i n ot uz u ma b 
oz o ga mici n.  N o patie nts ha d Q Tc F val ues greater t ha n 5 0 0 msec. Gra de 2 Q T pr ol o n gati o n 
was re p orte d i n 2/ 1 6 4 ( 1 %) patie nts.  N o Gra de 3 Q T pr ol o n gati o n or e ve nts of T orsa de de 
P oi ntes were re p orte d i n i n ot uz u ma b oz o ga mici n treate d patie nts.  I n t he c o ntr ol ar m, Q Tc F 
6 0 msec fr o m baseli ne were meas ure d i n 3/ 1 2 4 ( 2 %) patie nts, a n d 1/ 1 2 4 ( 1 %) patie nts ha d 
Q Tc F val ues > 5 0 0 msec. 1 3
Ce ntral te n de nc y  a nalys is of t he Q Tc F i nter val c ha n ges fr o m baseli ne s h o we d t hat t he 
hi g hest mea n ( u p per b o u n d of t he 2- si de d 9 0 % CI) f or Q Tc F was 1 5. 3 ( 2 1. 1) msec, w hic h 
was o bser ve d at C y cle 4/ Da y 1/ 1 h o ur i n t he i n ot uz u ma b oz o ga mici n- ar m. 1 3  Base d o n t he 
latest e x p os ure res p o nse a nalys is, alt h o u g h t here was a p ositi ve c orrelati o n bet wee n c orrecte d 
Q T ( Q Tc) i nter val wit h i n ot uz u ma b oz o ga mici n ser u m c o nce ntrati o n, t he u p per b o u n d o f t he 
9 5 % c o nfi de nce i nter val f or t he pre dicte d c ha n ges fr o m baseli ne i n Q Tc F a n d Q T i nter val 
c orrecte d f or heart rate usi n g a p o p ulati o n s pecific met h o d ( Q Tc S-), at t hera pe utic a n d 
s u prat hera pe utic ( 1. 5 f ol d t hera pe utic) c o nce ntrati o ns, re mai ne d bel o w t he 1 0 msec t hres h ol d 
( 4. 9 2- 8. 2 8 msec).
2. 2. 2. 2. P h ase 1/ 2 St u d y B 1 9 3 1 0 1 0
St u d y  B 1 9 3 1 0 1 0 was a P hase 1/ 2 si n gle -ar m, 2-sta ge, m ultice nter, o pe n-la bel st u d y 
e val uati n g -si n gle a ge nt i n ot uz u ma b oz o ga mici n f or t he treat me nt of rela pse d or refract or y  
A L L.  Res ults fr o m t h is st u d y hel pe d t o i nf or m t he i n ot uz u ma b oz o ga mici n d osi n g re gi me n 
use d i n P hase 3 St u d y  B 1 9 3 1 0 2 2.  -Ke y  eli gi bilit y criteria i ncl u de d a ge 1 8 ye ars a n d 
rela pse d or refract or y C D 2 2 p ositi ve A L L.  -F or t he P hase 2 part of t he st u d y , t he patie nts 
m ust ha ve b ee n d ue t o recei ve Sal va ge 2 t hera py.  Patie nts wit h P h + A L L ha d t o ha ve faile d 
treat me nt wit h at least 1 T KI. 1 5  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 6
T he P hase 1 d ose escalati o n p orti o n of St u d y B 1 9 3 1 0 1 0 was desi g ne d t o deter mi ne t he 
rec o m me n de d P hase 2 d ose ( R P 2 D) of wee kl y i n ot uz u ma b oz o ga mici n.  -T we nt y f o ur ( 2 4) 
patie nts were treate d wit h i n ot uz u ma b oz o ga mici n- at d ose le vels of 1. 2 m g / m2/c ycle ( n = 3), 
1. 6 m g/ m 2 per c y cle ( n = 1 2), or 1. 8 m g/ m 2/ c ycle ( n = 9). 1 5
Re missi o ns ( C R/ C Ri) were o bser ve d acr oss all d ose le vels: t he C R/ C Ri rate was 2/ 3 ( 6 6. 7 %) 
f or 1. 2 m g/ m 2 per c y cle, 9 / 1 2 ( 7 5. 0 %) f or 1. 6 m g/ m 2 per c ycle, a n d 8/ 9 ( 8 8. 9 %) f or 
1. 8 m g/ m 2 per c y cle M R D ne gati vit y was als o ac hie ve d a m o n g res p o n ders i n eac h d ose 
le vel; ti me t o M R D ne gati vit y was l o n gest f or t he 1. 2 m g/ m 2 per c y cle gr o u p. 1 5
T a ble 6 .
St u d y B 1 9 3 1 0 1 0: S u m m ar y of He m at ol o gic Re missi o n, Ti me t o 
He m at ol o gic Re missi o n, M R D Ne g ati vit y a n d Ti me t o M R D Ne g ati vit y 
f or P h ase 1 D ose Esc al ati o n C o h orts
P h ase 1, D ose Esc al ati o n
1. 2 m g/ m 2
1. 6 m g/ m 2
1. 8 m g/ m 2
N u m ber of P atie nts
( N = 3)
( N = 1 2)
( N = 9)
H e m at ol o gic re m issi o n 
r ate ( C R/ C Ri)
n ( %)
2 ( 6 6. 7)
9 ( 7 5. 0)
8 ( 8 8. 9)
9 5 % CI a
( 9. 4, 9 9. 2)
( 4 2. 8, 9 4. 5)
( 5 1. 8, 9 9. 7)
Ti me t o re missi o n 
( C R/ C Ri) ( d a ys)
N
2
9
8
Mea n
3 9. 0
3 5. 3
4 2. 8
S D
2 4. 0
1 2. 6
1 9. 9
Me dia n
3 9. 0
2 9. 0
3 8. 0
Ra n ge
2 2 -5 6
2 2 -5 9
2 2 -7 8
M R D
ne g ati vit y
n/ N ( %) b
2/ 2 ( 1 0 0)
8/ 9 ( 8 8. 8)
8/ 8 ( 1 0 0)
Ti me t o M R D
ne g ati vit y ( d a ys)
Me dia n (ra n ge)
9 8. 5( 9 8 -9 9)
3 2. 0( 2 2 -6 4)
3 0. 0( 2 2 -1 4 1)
A b bre viati o ns: CI =c o nfi de nce i nter val; C R =c o m plete res p o nse; C Ri =c o m plete res p o nse wit h i nc o m plete 
c o u nt rec o ver y; N/ n = n u m ber of patie nts S D =sta n dar d de viati o n.
Fi nal data fr o m c o m plete d st u d y.
a.
CI create d b y E xact Bi n o mial a p pr o xi mati o n.
b.
Perce nta ges were base d o n t he n u m ber of patie nts wit h C R/ C Ri.
2. 3. Be nefit/ Ris k Assess me nt
T he be nefit a n d ris k are de m o nstrate d i n pre vi o us st u d ies.  T he pri nci pal e vi de nce f or t he 
cli nical efficac y a n d safet y of i n ot uz u ma b oz o ga mici n i n patie nts wit h rela pse d or refract or y 
B- cell A L L is deri ve d fr o m pi v otal P hase 3 ra n d o mize d St u d y B 1 9 3 1 0 2 2 a n d s u p p orti ve 
P hase 1/ 2 si n gle -ar m St u d y B 1 9 3 1 0 1 0.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 7
St u d y  B 1 9 3 1 0 2 2 c o m pare d i n ot uz u ma b oz o ga mici n t o In vesti gat or’s c h oice of c he m ot hera p y 
(c o ntr ol) as Sal va ge 1 or 2 t hera p y i n a d ults wit h rela pse d or refract or y C D 2 2 p ositi ve B cell 
A L L.  T he st u d y met t he pri mar y  o bjecti ve of C R/ C Ri, wit h rates of 8 0. 7 % vs 2 9. 4 % f or 
i n ot uz u ma b oz o ga mici n a n d c o ntr ol ar ms, res pecti vely ( p val ue < 0. 0 0 0 1).  T he a nal ys is of 
O S di d n ot meet t he pres pecifie d b o u n dar y  f or statistical si g nifica nce.  At st u d y c o m pleti o n, 
t he esti mate d hazar d rati o ( H R) f or O S was 0. 7 5 ( 9 7. 5 % c o nfi de nce i nter val [ CI]: 0.5 7 - 0. 9 9, 
1 -si de d p -val ue 0. 0 1 0 5).  T he m o st c o m me nt (≥2 0 %) all -ca usalit y T E A Es i n t he i n ot uz u ma b 
oz o ga mici n ar m were T hr o m b oc y t o pe nia ( 4 9. 4 %), Ne utr o pe nia ( 4 8. 8 %), A nae mia ( 3 3. 5 %), 
Na usea ( 3 2. 3 %), P yr e xia ( 3 1. 7 %), Le u k o pe nia ( 2 8. 7 %), Hea dac he ( 2 7. 4 %), Fe brile 
ne utr o pe nia ( 2 6. 8 %), Fati g ue ( 2 5. 6 %), A S T i ncrease d ( 2 2. 6 %), a n d ga m ma gl uta m yl  
tra ns pe pti dase ( G G T) i ncrease d a n d h yper bilir u bi nae mia ( 2 1. 3 % eac h).
T he fre q ue nc y  of he patic ve n o -occl usi ve disease (V O D) (als o k n o w n as si n us oi dal 
o bstr ucti o n s y n dr o me [ S O S]) after a s u bse q ue nt H S C T was hi g her i n t he i n ot uz u ma b 
oz o ga mici n ar m c o m pare d t o t he c o ntr ol ar m ( 1 8/ 7 9 patie nts [ 2 3 %] vs 3/ 3 4 patie nts [ 9 %], 
res pecti vely).  Baseli ne c haracteristics t hat were i de ntifie d as p ote ntial ris k fact ors f or V O D 
p ost H S C T i n i n ot uz u ma b oz o ga mici n treate d patie nts i nc l u de d o n g oi n g or pri or li ver 
disease, pri or H S C T, i ncrease d a ge, a n d later sal va ge li nes.  T he use of H S C T c o n diti o ni n g 
re gi me ns c o ntai ni n g 2 al k ylati n g a ge nts, t otal bilir u bi n le vel greater t ha n or e q ual t o t he 
u p per li mit of n or mal bef ore H S C T, a n d a gre ater n u m ber of i n ot uz u ma b oz o ga mici n c ycles 
were als o ass ociate d wit h greater ris k of V O D.
Base d o n t he c o m pre he nsi ve data of i n ot uz u ma b oz o ga mici n fr o m pre vi o us st u dies, it is 
pr o p ose d t hat i n ot uz u ma b oz o ga mici n has a fa v ora ble be nefit-ris k pr ofile t hat justifies t his
st u d y.
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d reas o na bl y 
e x pecte d a d verse e ve nts ( A Es) of I n ot uz u ma b oz o ga mici n ma y  be f o u n d i n t he a p pr o ve d 
pac ka ge i nsert, w hic h is t he si n gle refere nce safet y d oc u me nt ( S R S D) f or t his st u d y.
3. O B J E C TI V E S, E S TI M A N D S, A N D E N D P OI N T S
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y:

T o e val uate t he efficac y of 
i n ot uz u ma b oz o ga mici n base d o n a 
pri mar y e n d p oi nt of c o m plete 
re missi o n [ C R]/c o m plete 
re missi o n wit h i nc o m plete 
he mat ol o gic rec o ver y [ C Ri] per 
I n vesti gat or’s assess me nt i n 
C hi nese a d ult patie nts wit h 
rela pse d/refract or y B-cell A L L.

T he treat me nt effect of 
i n ot uz u ma b oz o ga mici n fr o m 
t he ti me of first d ose u ntil e n d 
of treat me nt f or all patie nts 
w h o recei ve d at least o ne d ose 
of i n ot uz u ma b oz o ga mici n 
re gar dless of t olera bilit y a n d 
d urati o n o n treat me nt.

C R/ C Ri per i n vesti gat or ’s 
assess me nt .
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 8
O bjecti ves
Esti m a n ds
E n d p oi nts
Sec o n d ar y:

T o e val uate t he efficac y of 
i n ot uz u ma b oz o ga mici n.

T o e val uate t he safet y of 
i n ot uz u ma b oz o ga mici n.

T o e val uate P K of i n ot uz u ma b 
oz o ga mici n

T o e val uate t he i m m u n o ge nicit y of 
i n ot uz u ma b oz o ga mici n

D urati o n of re missi o n ( D o R).

Mi ni mal resi d ual disease ( M R D) 
ne gati vit y i n patie nts ac hie vi n g 
C R/ C Ri.

Pr o gressi o n- free s ur vi val ( P F S).

O verall s ur vi val ( O S).

He mat o p oietic ste m c ell tra ns pla nt
( H S C T). 

A Es a n d la b orat or y a b n or malities 
b y t y pe, fre q ue nc y, se verit y (as 
gra de d b y N CI C T C A E v 5. 0), 
ti mi n g, seri o us ness, a n d 
relati o ns hi p t o st u d y t hera p y,
i ncl u di n g V O D (t otal, d uri n g st u d y 
treat me nt, a n d p ost-H S C T).

I n ot uz u ma b oz o ga mici n Cma x a n d 
C tr o u g h.

I nci de nce of a nti-dr u g a nti b o dies 
( A D A) a n d ne utralizi n g a nti b o dies 
( N A b).
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
T his is a n o pe n -la bel, si n gle-ar m, m ultice nter st u d y i n C hi nese patie nts wit h rela pse d or 
refract or y C D 2 2 -p ositi ve B -cell A L L. T he o bjecti ve of t he st u d y is t o c o nfir m t he efficac y, 
safety, a n d P K of i n ot uz u ma b oz o ga mici n i n patie nts wit h rela pse d or refract or y B -cell A L L 
fr o m mai nla n d C hi na.
A p pr o xi matel y  4 4 mai nla n d C hi nese a d ult (≥1 8 years) patie nts w h o i nte n d t o recei ve eit her 
Sal va ge 1 or 2 thera p y wit h rela pse d or refract or y  C D 2 2-p ositi ve, P h + or P h - B-cell A L L 
will be e nr olle d t he st u d y. T o reflect t he ge neral rela pse d/refract or y  A L L patie nt p o p ulati o n, 
t he n u m ber of patie nts wit h P h+ disease will be ca p pe d at a p pr o xi matel y  2 0 % of t he e ntire 
trial p o p ulati o n.

Sal va ge 1: M or p h ol o gical rela pse after i nitial treat me nt or resista nt disease ( n o 
C R/ C Ri) after i nitial treat me nt;
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 3 9

Sal va ge 2: M or p h ol o gical rela pse after sal va ge 1 t hera p y or resi sta nt disease after 
sal va ge 1;
F or t his st u d y , m or p h ol o gic rela pse or resista nt/refract or y disease will be defi ne d as ≥5 % 
blast b y  m or p h ol o gic marr o w assess me nt ( or b y t he prese nce of circ ulati n g blasts if b o ne 
marr o w was n ot assesse d). T hera p y m o dificati o n(s) res ulti n g fr o m is olate d m o lec ular 
rela pse, i n t he a bse nce of m or p h ol o gic rela pse, will n ot be c o nsi dere d a sal va ge t hera p y.
T h e pri mar y  e n d p oi nt is C R/ C Ri a n d sec o n dar y efficac y e n d p oi nts i ncl u de D o R, M R D 
ne gati vit y  i n patie nts wit h C R/ C Ri, O S, P F S, HS C T , A d verse e ve nts a n d la b orat or y  
a b n or malities ( C T C A E v 5. 0 gra de, ti mi n g, seri o us ness a n d relate d ness) , V O D (t otal, d uri n g 
st u d y treat me nt, a n d p ost-H S C T) , P K para meter a n d i m m u n o ge nicity.
T he d osi n g re gi me n f or i n ot uz u ma b oz o ga mici n i n t he C hi na p ost a p pr o val st u d y  will be t he 
sa me as t hat use d i n N M P A-a p pr o ve d la beli n g. Patie nts will be treate d wit h i n ot uz u ma b
oz o ga mici n f or a ma xi m u m d ose of 1. 8 m g/ m 2 per c ycle wit h a s plit d ose re gi me n usi n g 
wee kl y a d mi nistrati o ns. Patie nts will recei ve 0. 8 m g/ m 2 o n wee k 1, f oll o we d b y 0. 5 m g/ m 2
o n wee ks 2 a n d 3 e ver y 2 1 - 2 8 da y s c ycle. I n C y cle 2 a n d be y o n d, t he i n ot uz u ma b oz o ga mici n
d ose a d mi nistere d o n wee k 1 will be re d uce d t o 0. 5 m g/ m 2 i n patie nts ac hie vi n g C R/ C Ri (f or
a t otal c ycle d ose of 1. 5 m g/ m 2). 
Patie nts w h o d o n ot ac hie ve a C R or C Ri wit hi n 3 c y cles s h o ul d disc o nti n ue treat me nt. A 
t hir d c ycle ma y be c o nsi dere d f or t h ose patie nts w h o d o n ot ac hie ve C R or C Ri a n d M R D 
ne gati vit y  after 2 c ycles. F or patie nts n ot pr ocee di n g t o H S C T, a d diti o nal c ycles of treat m e nt, 
u p t o a ma xi m u m of 6 c ycles, ma y  be a d mi nistere d.
All cases of V O D/ S O S irres pecti ve of ca usalit y  or se verity will be re p orte d as S A Es f or u p t o 
2 ye ars after t he first d ose of i n ot uz u ma b oz o ga mici n. A n i n de pe n de nt he patic e ve nt 
a dj u dicati o n c o m mittee will e val uate safety f or p ote ntial V O D/ S O S e ve nts a n d H y ’s la w 
cases . S ur vi val will be f oll o w e d u p t o 2 years fr o m first d ose.
P K sa m ples will be c ollecte d f or all 4 4 patie nts i n t he st u d y  t o descri be p o p ulati o n P K 
pr ofiles.
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
In ot uz u ma b oz o ga mici n is a n a nti b o d y directe d a gai nst t he C D 2 2 a nti ge n, c o nj u gate d wit h a
c yt ot o xic a ntit u m or a nti bi otic (calic hea mici n) i n de vel o p me nt f or t he treat me nt of B cell
mali g na ncies s uc h as n o n -H o d g ki n’s l ym p h o ma ( N H L) a n d A L L.  C D 2 2 is e x presse d o n t he
mali g na nt cells of t he maj orit y of B- l ym p h oc y te mali g na ncies, i ncl u di n g o n t he s urface of
B cell A L L blasts i n t he vast maj orit y of patie nts ( > 9 0 %).2
I n ot uz u ma b oz o ga mici n ( B E S P O N S A® ) is c urre ntl y a p pr o ve d i n t he U nite d States ( U S), t he 
E ur o pea n U ni o n ( E U), S witzerla n d (a p pr o vals gra nte d i n 2 0 1 7), a n d Ja pa n (a p pr o val gra nte d
i n 2 0 1 8), a n d Chi na (a p pr o val gra nte d i n 2 0 2 1) .  A p pr o val was base d o n de m o nstrati o n of a 
p ositi ve be nefit/ris k f or t he treat me nt of a d ults wit h rela pse d or refract or y  B-cell prec urs or 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 0
A L L. O n 2 0 Dec 2 0 2 1, Bes p o nsa was a p pr o ve d b y N M P A f or t he treat me nt of a d ults wit h 
rela pse d or refract or y B-cell prec urs or A L L.
T he acti vit y  of t he c urre ntl y a p pr o ve d i n ot uz u ma b oz o ga mici n d osi n g re gi me n was 
de m o nstrate d i n a ra n d o mize d ( 1: 1), o pe n la bel, i nter nati o nal P hase 3 st u d y  ( B 1 9 3 1 0 2 2).  
St u d y B 1 9 3 1 0 2 2 c o m pare d i n ot uz u ma b oz o ga mici n t o I n vesti gat or’s c h oice of c he m ot hera p y 
(c o ntr ol) as Sal va ge 1 or 2 t hera p y i n a d ults wit h rela pse d or refract or y C D 2 2 p ositi ve B- cell 
A L L.  I n vesti gat or’s c h oice of c he m ot hera py was fl u dara bi ne + c ytara bi ne + gra n ul oc yte 
c ol o n y sti m ulati n g fact or ( F L A G), hi g h d ose c y tara bi ne ( HI D A C), or 
mit o xa ntr o ne + c ytara bi ne ( M X N/ Ara- C).  Patie nts wit h P h + disease m ust ha ve faile d 
treat me nt wit h at least 1 t yr osi ne ki nase i n hi bit or ( T KI) a n d sta n dar d c he m ot hera p y.  T he 
pri mar y  e n d p oi nts were C R/ C Ri, assesse d b y a bli n de d i n de pe n de nt E A C, a n d O S.  T he 
sec o n dar y e n d p oi nts i ncl u de d M R D-ne gati vit y , D o R, H S C T rate, a n d P F S. 
T h e a nal ys is of C R/ C Ri base d o n t he I T T p o p ulati o n ( data c ut off date 0 8 Marc h 2 0 1 6) a n d a 
s u b gr o u p a nalys is i n Asia n patie nts ( by race a n d ge o gra p hi c re gi o n) a n d mai nla n d C hi nese 
patie nts. 
All (I T T) p atie nts: At t his later c ut off date ( 0 8 Marc h 2 0 1 6), t he i m pr o ve me nt i n 
C R/ C Ri per I n vesti gat or’s assess me nt i n t he I T T p o p ulati o n was c o nsiste nt wit h 
t he pre vi o us (I T T 2 1 8) a nal ysis.  I n ot uz u ma b oz o ga mici n de m o nstrate d a 
statisticall y si g nifica nt a n d cli nicall y meani n gf ul i m pr o ve me nt i n C R/ C Ri ( per 
I n vesti gat or’s assess me nt) c o m pare d t o I n vesti gat or’s c h oice of c he m ot hera p y 
( 7 3. 2 % vs 3 0. 9 % f or a rate differe nce of 4 2. 3 % [ 9 7. 5 % CI: 3 1. 1, 5 3. 5] wit h 1-si de d 
p < 0. 0 0 0 1). 
M ai nl a n d C hi nese p atie nts : I n mai nla n d C hi nese patie nts, 5 o ut of 6 ( 8 3. 3 %) patie nts 
res p o n de d t o i n ot uz u ma b oz o ga mici n treat me nt w hile 2 o ut of 6 ( 3 3. 3 %) patie nts 
res p o n de d t o t he I n vesti gat or’s c h oice of c he m ot hera py.
Asi a n p atie nts: I n Asia n patie nts, a c o nsiste nt a n d cli nicall y mea ni n gf ul i m pr o ve me nt
i n C R/ C Ri c o m pare d t o I n vesti gat or’s c h oice of c he m ot hera py was als o o bser ve d.  
I n Asia n ( by race) patie nts, C R/ C Ri was 7 1. 0 % vs 2 0. 8 % (rate differe nce of 
5 0. 1 % [ 9 7. 5 % CI : 2 4. 1-7 6. 2]) a n d i n Asia n ( b y ge o gra p hic re gi o n) patie nts, 
C R/ C Ri was 7 3. 1 % vs 2 9. 4 % (rate differe nce of 4 3. 7 % [ 9 7. 5 % CI: 1 2. 1, 7 5. 2]). 
T he pri mar y  a nalys is of O S base d o n t he I T T p o p ulati o n ( data c ut off date 0 8 Marc h 2 0 1 6) 
a n d a s u b gr o u p a nal ys is i n Asia n patie nts ( by race a n d re gi o n) a n d mai nla n d C hi nese 
patie nts.  
All (I T T) p atie nts: I n t he I T T p o p ulati o n ( data c ut off date 0 8 Marc h 2 0 1 6), t he 
me dia n O S was 7. 7 m o nt hs vs 6. 7 m o nt hs a n d a n esti mate d H R= 0. 7 7 0 ( 9 7. 5 % CI : 
0. 5 7 8 -1. 0 2 6; 1 -si de d p = 0. 0 2 0 3) base d o n t he stratifie d a nalys is a n d H R =0. 7 4 8 
(9 7. 5 % CI : 0. 5 6 3, 0. 9 9 3; 1-si de d p = 0. 0 1 0 4) base d o n t he u n stratifie d a nalys is.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 1
M ai nl a n d C hi nese p atie nts:
I n mai nla n d C hi nese patie nts, O S was c o nsiste nt wit h t he 
o verall res ults i n t he I T T p o p ulati o n rec o g nizi n g t he wi de CIs f or t he H R, d ue t o 
t he s mall sa m ple size ( n = 1 2); w hic h o verla p pe d wit h the I T T p o p ulati o n.  I n 
mai nla n d C hi nese patie nts, me dia n O S was 6. 0 m o nt hs vs 8. 0 m o nt hs a n d 
H R = 0. 7 9 7 ( 9 7. 5 % CI : 0. 1 7 0, 3. 7 3 5) base d o n t he u nstratifie d a nalys is.
Asi a n p atie nts: I n Asia n patie nts, O S fi n di n gs were c o nsiste nt wit h t he o verall res ults 
i n t he IT T p o p ulati o n ( w hic h s h o w a cli nicall y mea ni n gf ul i m pr o ve me nt i n O S) 
rec o g nizi n g t he wi de CIs f or t he H Rs, d ue t o s mall sa m ple sizes ( n = 5 5 [ Asia n b y 
race] a n d 4 3 [ Asia ns by ge o gra p hic re gi o n]), w hic h o verla p pe d wit h t he I T T 
p o p ulati o n.  I n Asia ns ( b y  r ace) patie nts, me dia n O S was 5. 8 m o nt hs vs 3. 9 m o nt hs 
a n d H R = 0. 8 1 5 ( 9 7. 5 % CI: 0. 4 0 9, 1. 6 2 4).  I n Asia n ( b y ge o gra p hic re gi o n) 
patie nts, me dia n O S was 6. 5 m o nt hs vs 5. 3 m o nt hs a n d H R = 1. 2 3 0 ( 9 7. 5 % CI: 
0. 5 3 7, 2. 8 1 8) base d o n t he u n stratifie d a nal ysis. 
F or C hi na, b ase d o n t he c o m pre he nsi ve data a vaila ble o n i n ot uz u ma b oz o ga mici n, a n d t he 
si milarities i n efficac y, safety, a n d P K bet wee n races a n d ge o gra p hic re gi o ns, C hi na Ce nter 
f or D r ug E val uati o n ( C D E ) a ge nc y has a gree d t o Pfizer’s pr o p osal t o s u b mit a cli nical trial 
wai ver ( C T W) at t he ti me of t he ne w dr u g a p plicati o n ( N D A) s u b missi o n a n d c o n d uct a 
cli nical trial i n C hi nese patie nts as a p ost a p pr o val c o m mit me nt (P A C ) t o s u p p ort t he 
re gistrati o n of i n ot uz u ma b oz o ga mici n f or t he treat me nt of patie nts wit h rela pse d or 
refract or y B-cell A L L i n C hi na. T he st u d y  desi g n refers t o t he gl o bal P hase 3 B 1 9 3 1 0 2 2 
st u d y. P A C st u d y  p o p ulati o n will be t he sa me as t hat use d i n gl o bal pi v otal P hase 3 St u d y  
B 1 9 3 1 0 2 2. Mai nla n d C hi nese a d ult ( ≥1 8 y ears) patie nts w h o i nte n d t o recei ve eit her Sal va ge 
1 or 2 thera p y wi t h rela pse d or refract or y C D 2 2-p ositi ve, P h ( +) or P h (-) B-cell A L L will be 
e nr olle d i n t his st u d y. A p pr o ve d d osi n g re gi me n of i n ot uz u ma b oz o ga mici n will be use d i n 
t his st u d y.
4. 3. J ustific ati o n f or D ose
I n ot uz u ma b oz o ga mici n d ose selecti o n i n t his st u d y was sa me as use d i n t he gl o bal P hase 3 
st u d y ( B 1 9 3 1 0 2 2) a n d was a p pr o ve d by N M P A. 
D ose m o dificati o n is all o we d i n t he e ve nt of t o xicit y , t he s pecific deificati o n see Secti o n 6. 6 .
4. 4. E n d of St u d y Defi niti o n
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y  if he/s he has c o m plete d all p hases of 
t he st u d y i ncl u di n g scree ni n g, treat me nt peri o d, disease f oll o w u p a n d s ur vi val f oll o w u p.
F or eac h patie nt s ur vi val f oll o w u p will start after d oc u me nte d disease pr o gressi o n a n d 
c o nti n ui n g f or u p t o 2 ye ars fr o m t he first d ose ( Da y 1 C y cle 1).
T he e n d of t he st u d y is defi ne d as t he date of t he last partici pa nt c o m pleti o n of s ur vi val 
f oll o w u p, it will be u p t o 2 years fr o m first d ose of t he last patie nt .  S ur vi val f oll o w u p ca n 
be c o n d ucte d b y t ele p h o ne or e mail.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 2
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nts are e nr olle d.  T he 
f oll o wi n g eli gi bilit y criteria are desi g ne d t o select partici pa nts f or w h o m partici pati o n i n t he 
st u d y is c o nsi dere d a p pr o priate.  All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be 
ta ke n i nt o c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt is s uita ble f or t his 
pr ot oc ol. 
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria, als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
A ge a n d Se x:
1.
Male or fe male partici pa nts , age 1 8 years or ol der at scree ni n g.
T y pe of P artici p a nt a n d Dise ase C h ar acteristics:
2.
Rela pse d or refract or y  C D 2 2- p ositi ve A L L ( ≥5 % marr o w blasts, assesse d b y 
m or p h ol o g y ) d ue t o recei ve eit her sal va ge 1 or sal va ge 2 t hera p y a n d f or w hic h 
treat me nt wit h i n ot uz u ma b oz o ga mici n offers a reas o na ble treat me nt o pti o n.
3.
P h + A L L patie nts m ust ha ve faile d treat me nt wit h at least 1 t yr osi ne ki nase i n hi bit or
a n d sta n dar d m ulti -a ge nt i n d ucti o n c he m ot hera p y.
4.
Patie nts i n Sal va ge 1 wit h late rela pse s h o ul d be dee me d p o or ca n di dates f or 
rei n d ucti o n wit h i nitial t hera p y.
5.
Patie nts wit h l ym p h o blastic l ym p h o ma a n d b o ne marr o w i n v ol ve me nt 
≥5 % l ym p h o blasts
b y m or p h ol o gic ass ess me nt.
6.
E C O G perf or ma nce stat us 0 -2.
7.
A de q uate li ver f u ncti o n, i ncl u di n g t otal ser u m bilir u bi n ≤1. 5 × U L N u nless t he 
patie nt has d oc u me nte d Gil bert s y n dr o me, a n d as partate a n d ala ni ne a mi n otra nsferase 
( A S T a n d A L T) ≤2. 5 × U L N.   If or ga n f u ncti o n a b n or malities are c o nsi dere d d ue t o 
t u m or, t otal ser u m bilir u bi n m ust be ≤2 × U L N a n d A S T/ A L T ≤2. 5 × U L N.
8.
Ser u m creati ni ne ≤1. 5 × u p per li mit of n or mal ( U L N) or a n y ser u m creati ni ne le vel
ass ociate d wit h a meas ure d or calc ulate d creati ni ne cleara nce of ≥4 0 m L/ mi n.
9.
Male a n d fe male patie nts of c hil d beari n g p ote ntial a n d at ris k f or pre g na nc y  m ust 
a gree t o use a hi g hl y effecti ve met h o d of c o ntrace pti o n t hr o u g h o ut t he st u d y a n d f or a 
mi ni m u m of 8 m o nt hs (fe males) a n d 5 m o nt hs ( males) after t he last d ose of assi g ne d 
treat me nt.  A patie nt is of c hil d beari n g p ote ntial if, i n t he o pi ni o n of t he In vesti gat or, 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 3
he/s he is bi ol o gicall y ca pa ble of ha vi n g c hil dre n a n d is se x uall y  acti ve.  Fe male 
s u bjects of n o nc hil d beari n g p ote ntial m ust meet at least 1 of t he f oll o wi n g criteria: 
a.
Ac hie ve d p ost me n o pa usal stat us, defi ne d as f oll o ws: cessati o n of re g ular me nses 
f or at least 1 2 c o nsec uti ve m o nt hs wit h n o alter nati ve pat h ol o gical or 
p h y si ol o gical ca use; a n d ha ve a ser u m f ollicle sti m ulati n g h or m o ne ( F S H) le vel 
c o nfir mi n g t he p ost me n o pa u sal state;
b.
Ha ve u n der g o ne a d oc u me nte d h y sterect o m y a n d/ or bilateral o o p h orect o m y; 
c.
Ha ve me dicall y  c o nfir me d o varia n fail ure. 
All ot her fe male s u bjects (i ncl u di n g fe male s u bjects wit h t u bal li gati o ns) are c o nsi dere d t o be 
of c hil d beari n g p ote ntial. 
I nf orme d C o nse nt:
1 0. Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n Secti o n 1 0. 1 , A p pe n di x 1 , 
w hic h i ncl u des c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he 
i nf or me d c o nse nt d oc u me nt (IC D) a n d i n t his pr ot oc ol.
5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y  if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns:
1.
Is olate d e xtra me d ullar y rela pse (ie, testic ular or ce ntral ner v o us sys te m [ C N S]).
2.
B ur kitt’s or mi xe d p he n ot y pe ac ute le u ke mia base d o n t he W orl d Healt h 
Or ga nizati o n ( W H O) 2 0 0 8 criteria.
3.
Acti ve C N S le u ke mia, as defi ne d b y u ne q ui v ocal m or p h ol o gic e vi de nce of 
l ym p h o b lasts i n t he cere br os pi nal fl ui d ( C S F), use of C N S- directe d l ocal treat me nt 
f or acti ve disease wit hi n t he pri or 2 8 da ys, sy m pt o matic C N S le u ke mia (ie, cra nial 
ner ve palsies or ot her si g nifica nt ne ur ol o gic d ys f u ncti o n) wit hi n 2 8 da ys.  
Pr o p h y lactic i ntrat hecal me dicati o n is n ot a reas o n f or e xcl usi o n.
4.
Maj or s ur ger y
wit hi n ≤4 wee ks bef ore C y cle 1 Da y 1.
5.
U nsta ble or se vere u nc o ntr olle d me dical c o n diti o n (e g, u nsta ble car diac f u ncti o n or 
u nsta ble p ul m o nar y c o n diti o n).
6.
C o nc urre nt acti ve mali g na nc y ot her t ha n n o n -mela n o ma s ki n ca ncer, carci n o ma i n 
sit u of t he cer vi x, or l ocalize d pr ostate ca ncer t hat has bee n defi nitel y treate d wit h 
ra diati o n or s ur ger y.  Patie nts wit h pre vi o us mali g na ncies are eli gi ble pr o vi de d t hat 
t he y ha ve bee n disease free f or ≥2 years.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 4
7.
Car diac f u ncti o n, as meas ure d b y left ve ntric ular ejecti o n fracti o n ( L V E F) t hat is less
t ha n 4 5 %, or t he prese nce of Ne w Y or k Heart Ass ociati o n ( N Y H A) sta ge III or I V
c o n gesti ve heart fail ure.
8.
Patie nts wit h acti ve heart disease ( N Y H A class ≥3 as assesse d b y hist or y a n d p h y sical
e xa mi nati o n).
9.
M y ocar dial i nfarcti o n ≤6 m o nt hs bef ore C ycle 1 Da y 1.
1 0. Hist or y  of cli nicall y si g nifica nt ve ntric ular arr h yt h mia, or u ne x plai ne d s ync o pe n ot 
belie ve d t o be vas o va gal i n nat ure, or c hr o nic bra d y car dic states s uc h as si n oat rial 
bl oc k or hi g her de grees of atri o ve ntric ular ( A V) bl oc k u nless a per ma ne nt pace ma ker 
has bee n i m pla nte d.
1 1. U nc o ntr olle d electr ol yt e dis or ders t hat ca n c o m p o u n d t he effects of a Q Tc pr ol o n gi n g 
dr u g (e g, h y p o kale mia, h y p ocalce mia, h y p o ma g nese mia).
1 2. Hist or y  of c hr o nic li ver disease (e g, cirr h osis) or s us pecte d alc o h ol a b use.
1 3. Hist or y  of he patic ve n o-occl usi ve disease ( V O D) or si n us oi dal o bstr ucti o n s y n dr o me 
( S O S).
1 4. E vi de nce of u nc o ntr olle d c urre nt seri o us acti ve i nfecti o n (i ncl u di n g se psis, 
bactere mia, f u n ge mia ) or patie nts wit h a rece nt hist or y ( wit hi n 4 m o nt hs) of dee p 
tiss ue i nfecti o ns s uc h as fascitis or oste o m yelitis.
1 5. Patie nts w h o ha ve ha d a se vere aller gic reacti o n or a na p h yl actic reacti o n t o a n y 
h u ma nize d m o n ocl o nal a nti b o dies.
1 6. Ot her ac ute or c hr o nic me di cal or ps yc hi atric c o n diti o n i ncl u di n g rece nt ( wit hi n t he 
past y ear) or acti ve s uici dal i deati o n or be ha vi or or la b orat or y  a b n or malit y t hat ma y 
i ncrease t he ris k ass ociate d wit h st u d y partici pati o n or i n vesti gati o nal pr o d uct 
a d mi nistrati o n or ma y i nterfere wit h t he i nter pretati o n of st u d y  res ults a n d, i n t he 
j u d g me nt of t he i n vesti gat or, w o ul d ma ke t he partici pa nt i na p pr o priate f or e ntr y i nt o 
t his st u d y.
Pri or/ C o nc o mit a nt T her a p y:
1 7. Pri or c he m ot hera p y wit hi n 2 wee ks bef ore e nr oll me nt wit h t he f oll o wi n g e xce pti o ns:
a.
T o re d uce t he circ ulati n g l y m p h o blast c o u nt or palliati o n: ster oi ds, h y dr o x y urea 
or vi ncristi ne;
b.
F or A L L mai nte na nce: merca pt o p uri ne, met h otre xate, vi ncristi ne, t hi o g ua ni ne,
a n d/ or t yr osi ne ki nase i n hi bit ors.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 5
1 8. Patie nts m ust ha ve rec o vere d fr o m a c ute n o n he mat ol o gic t o xicit y (t o ≤Gra de 1) of all 
pre vi o us t hera p y  pri or t o e nr oll me nt.
1 9. Pri or m o n ocl o nal a nti b o dies wit hi n 6 wee ks of e nr oll me nt, wit h t he e xce pti o n of 
rit u xi ma b w hic h m ust be disc o nti n ue d at least 2 wee ks pri or t o C y cle 1 Da y 1.
2 0. Pri or all o ge neic he mat o p oietic ste m cell tra ns pla nt ( H S C T) or ot her a nti -C D 2 2 
i m m u n ot hera p y ≤4 m o nt hs bef ore e nr oll me nt.  Patie nts m ust ha ve c o m plete d 
i m m u n os u p pressi o n t hera p y f or treat me nt of graft vers us h ost disease ( G v H D) 2 6 , 
2 7pri or t o e nr oll me nt.  At e nr oll me nt , patie nts m ust n ot ha ve ≥Gra de 2 ac ute G v H D, or 
e xtensi ve c hr o nic G v H D.
2 1. A d mi nistrati o n of li ve vacci ne ≤6 wee ks bef ore e nr oll me nt.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
2 2. Pre vi o us a d mi nistrati o n wit h a n i n vesti gati o nal dr u g wit hi n 3 0 d a y s ( or as deter mi ne d 
b y  t he l ocal re q uire me nt) or 5 half -li ves prece di n g t he first d ose of i n vesti gati o nal 
pr o d uct use d i n t his st u d y  ( w hic he ver is l o n ger).
Di a g n ostic Assess me nts:
2 3. Peri p heral a bs ol ute l y m p h o blast c o u nt ≥1 0, 0 0 0 / µ L (treat me nt wit h h y dr o x y urea 
a n d/ or ster oi ds/ vi ncristi ne is per mitte d wit hi n 2 wee ks of C ycle 1 Da y 1 t o re d uce t he 
w hite bl o o d cell [ W B C] c o u nt).
2 4. K n o w n s y ste mic vasc uliti des (e g, We ge ner’s gra n ul o mat osis, p ol yarteritis n o d osa, 
s yste mic l u p us er yt he mat os us), pri mar y or sec o n dar y i m m u n o deficie nc y (s uc h as 
h u ma n i m m u n o deficie nc y vir us [ HI V] i nfe cti o n or se vere i nfla m mat or y disease).
2 5. C urre nt or c hr o nic he patitis B or C i nfecti o n as e vi de nce d b y he patitis B s urface 
a nti ge n a n d a nti -he patitis C a nti b o d y  p ositi vit y, res pecti vel y, or k n o w n ser o p ositi vit y 
f or HI V.  HI V testi n g ma y nee d t o be perf or me d i n acc or da nce wit h l ocal re g ulati o ns 
or l ocal practice.
2 6. Q Tc F > 4 7 0 msec ( base d o n t he a vera ge of 3 c o nsec uti ve electr ocar di o gra ms [ E C Gs]).
Ot her E xcl usi o ns:
2 7. I n vesti gat or site staff me m bers directly i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir 
fa mil y me m bers, site staff me m bers ot her wise s u per vise d b y t he i n vesti gat or, or 
Pfizer e m pl o y ees, i ncl u di n g t heir fa mil y me m bers, directl y i n v ol ve d i n t he c o n d uct of 
t he st u d y. 
2 8. Pre g na nt fe male s u bjects; breastfee di n g fe male s u bjects; fertile male s u bjects a n d 
fe male s u bjects of c hil d beari n g p ote ntial w h o are u n willi n g or u na ble t o use hi g hly 
effecti ve c o ntrace pti o n as o utli ne d i n t his pr ot oc ol f or t he d urati o n of t he st u d y a n d 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 6
f or a mi ni m u m of 8 m o nt hs (fe males) a n d 5 m o nt hs ( males) after t he last d ose of 
i n vesti gati o nal pr o d uct.
5. 3. Lifest yle C o nsi der ati o ns
5. 3. 1. C o ntr ace pti o n
T he i n vesti gat or or his or her desi g nee, i n c o ns ultati o n wit h t he partici pa nt, will c o nfir m t hat 
t he partici pa nt has selecte d a n a p pr o priate met h o d of c o ntrace pti o n f or t he i n di vi d ual 
partici pa nt a n d his or her part ner(s) fr o m t he per mitte d list of c o ntrace pti o n met h o ds (see 
Secti o n 1 0. 4. 4   A p pe n di x 4 ) a n d will c o nfir m t hat t he partici pa nt has bee n i nstr ucte d i n its 
c o nsiste nt a n d c orrect use.  At ti me p oi nts i n dicate d i n t he S c he d ule of Acti vities   (S o A ), t he 
i n vesti gat or or desi g nee will i nf or m t he partici pa nt of t he nee d t o use hi g hl y effecti ve 
c o ntrace pti o n c o nsiste ntl y a n d c orrectl y a n d d oc u me nt t he c o n versati o n a n d t he partici pa nt’ s 
affir mati o n i n t he partici pa nt’s c hart ( partici pa nts nee d t o affir m t heir c o nsiste nt a n d c orrect 
use of at least 1 of t he selecte d met h o ds of c o ntrace pti o n).  I n a d diti o n, t he i n vesti gat or or 
desi g nee will i nstr uct t he partici pa nt t o call i m me diatel y  if t he selecte d c o ntrace pti o n met h o d 
is disc o nti n ue d or if pre g na nc y is k n o w n or s us pecte d i n t he partici pa nt or part ner.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y  b ut 
are n ot s u bse q ue ntl y e ntere d i n t he st u d y.  A mi ni mal set of scree n fail ure i nf or mati o n is 
re q uire d t o e ns ure tra ns pare nt re p orti n g of scree n fail ure partici pa nts t o meet t he 
C o ns oli date d Sta n dar ds of Re p orti n g Trials ( C O N S O R T) p u blis hi n g re q uire me nts a n d t o 
res p o n d t o q ueries fro m re g ulat or y  a ut h orities.  Mi ni mal i nf or mati o n i ncl u des de m o gra p h y, 
scree n fail ure details, eli gi bilit y criteria, a n d a n y seri o us a d verse e ve nt ( S A E).
Patie nts w h o are scree ne d a n d meet t he e xcl usi o n criteria or fail t o f ulfill t he i ncl usi o n 
criteria c o uld be re -scree ne d o nce, d uri n g t he o pe n scree ni n g peri o d of t he st u d y.  T here is n o 
re q uire me nt f or a waiti n g peri o d bet wee n t he scree n-fail ure date a n d t he re-scree ni n g date, 
a n d a differe nt patie nt i de ntificati o n n u m ber will be iss ue d.  Patie nts w h o are r e-scree ne d 
m ust si g n a ne w c o nse nt f or m, a n d all scree ni n g pr oce d ures m ust be re peate d.
6. S T U D Y I N T E R V E N TI O N( S ) A N D C O N C O MI T A N T T HE R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d n o n-i n vesti gati o nal me dici nal 
pr o d ucts/a u xiliar y  me dici nal pr o d ucts, me dical de vices, a n d ot her i nter ve nti o ns (e g, s ur gical 
a n d be ha vi oral) i nte n de d t o be a d mi nistere d t o t he st u d y  partici pa nts d uri n g t he st u d y 
c o n d uct.
F or t he p ur p oses of t his pr ot oc ol, st u d y  i nter ve nti o n refers t o in ot uz u ma b oz o ga mici n.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 7
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
T a ble 7 .
St u d y I nter ve nti o n A d mi nistere d
I nter ve nti o n N a me
I n ot uz u ma b oz o ga mici n.
A R M N a m e
S i n gle ar m.
T y pe
I nter ve nti o n Ty pe: Dr u g.
D ose F or m ul ati o n
T he i n ot uz u ma b oz o ga mici n dr u g pr o d uct is pre pare d as a 
l yo p hilize d p o w der. T he dr u g pr o d uct is f or m ulate d wit h 2 0 
m M tr o met ha mi ne ( p H 8. 0), 5 % ( w / v) s ucr ose, 0. 0 1 % ( w/ v) 
p ol ys or bate 8 0, a n d 1 0 m M s o di u m c hl ori de.
U nit D ose Stre n gt h(s)
1 m g/ vial.
D os a ge Le vel(s)
See Secti o n 6. 1. 1 .
R o ute of A d m i nistr ati o n
I ntra ve n o us (I V).
U se
E x peri me ntal
I n vesti g ati o n al Me dici n al Pr o d uct 
(I M P) or N o ni n vesti g ati o n al Me dici n al 
Pr o d uct ( NI M P)
I M P.
S o urci n g
Pr o vi de d ce ntrall y b y t he s p o ns or.
P ac k a gi n g a n d L a beli n g
I n ot uz u ma b oz o ga mici n is pr o vi de d i n C hi na c o m mercial 
prese ntati o n as a l y o p hilize d, u n preser ve d w hite t o off -w hite 
p o w der i n a n a m ber vial f or i ntra ve n o us i njecti o n.  Eac h vial 
will be la bele d as re q uire d per c o u ntr y re q uire me nt. 
6. 1. 1. A d mi nistr ati o n
See t he I n vesti gati o nal Pr o d uct Ma n ual f or i nstr ucti o ns o n h o w t o a d mi nister i n ot uz u ma b 
oz o ga mici n. 
Pre me dicati o n is re q uire d f or all s u bjects.  Pre- me dicate wit h a c ortic oster oi d, a nti p y retic, 
a n d a nti hista mi ne.  Pre me dicati o n ma y  als o i ncl u de a ntie metics. 
Pati e nts s h o ul d be o bser ve d d uri n g a n d f or at least 1 h o ur after t he e n d of st u d y  i nter ve nti o n 
i nf usi o n f or s y m pt o ms of i nf usi o n relate d reacti o ns. I n cases of i nf usi o n relate d reacti o ns, 
i nterr u pt t he i nf usi o n a n d i nstit ute a p pr o priate me dical ma na ge me nt.  De pe n di n g o n t he 
se verity of t he i nf usi o n relate d reacti o n, c o nsi der disc o nti n uati o n of t he i nf usi o n or 
a d mi nistrati o n of ster oi ds a n d a nti hista mi nes.  F or se vere or life -t hreate ni n g i nf usi o n 
reacti o ns, per ma ne ntly disc o nti n ue treat me nt.
Pr o p h y lactic C N S c he m ot hera p y (i ntrat hecal) is str o n gly rec o m me n de d d uri n g st u dy
partici pati o n.
T he starti n g d ose of i n ot uz u ma b oz o ga mici n is 1. 8 m g/ m 2 per c y cle (a d mi nistere d i n 
3 di vi de d d oses).  After C R/ C Ri is ac hie ve d, t he d ose is re d uce d t o 1. 5 m g/ m 2 per c ycle 
(a d mi nistere d i n 3 di vi de d d oses).  T he c ycle le n gt h will be 2 1 - 2 8 d a y s.  I n ot uz u ma b 
oz o ga mici n is a d mi nistere d o n Da y s 1, 8, a n d 1 5.
F or patie nts pr ocee di n g t o H S C T, 2 c ycles of i n ot uz u ma b oz o ga mici n are rec o m me n de d.  A 
t hir d c ycle ma y be c o nsi dere d f or t h ose patie nts w h o d o n ot ac hie ve C R/ C Ri a n d M R D 
ne gati vit y  after 2 c ycles.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 8
Patie nts w h o d o n ot ac hie ve a C R/ C Ri wit hi n 3 c ycles s h o ul d disc o nti n ue treat me nt. 
T he d osi n g sc he d ule is s h o w n i n Ta ble 8.
T a ble 8 .
D osi n g Sc he d ule: I n ot uz u m a b Oz o g a mici n St arti n g D ose of 
1. 8 m g/ m 2/c ycle ( a d mi nistere d i n 3 di vi de d d oses)
D a y 1
D a y 8 a
D a y 1 5 a
D osi n g re gi me n f or C ycle 1 ( 1. 8 m g/ m 2/c ycle)
All p atie nts:
D ose b
0. 8 m g/ m 2
0. 5 m g/ m 2
0. 5 m g/ m 2
C y cle le n gt h
2 1 da ys c
D osi n g re gi me n f or s u bse q ue nt c ycles de pe n di n g o n res p o nse t o tre at m e nt
P atie nts w h o h a ve ac hie ve d a C R d or C Ri e ( 1. 5 mg/ m 2/c ycle)
D ose b
0. 5 m g/ m 2
0. 5 m g/ m 2
0. 5 m g/ m 2
C y cle le n gt h
2 8 da ys f
P atie nts w h o h a ve n ot ac hie ve d a C R d or C Ri e ( 1. 8 mg/ m 2/c ycle)
D ose b
0. 8 m g/ m 2
0. 5 m g/ m 2
0. 5 m g/ m 2
C y cle le n gt h
2 8 da ys f
A b bre viati o ns: C R =c o m plete re missi o n; C Ri =c o m plete re missi o n wit h i nc o m plete he mat ol o gic rec o ver y.
a.
2 da ys ( mai ntai n mini m u m  of 6 da ys bet wee n d oses). 
b.
D ose is base d o n t he patie nt’s b o d y s urface area ( m 2). 
c.
F or patie nts w h o ac hie ve a C R or a C Ri, a n d/ or t o all o w f or rec o ver y fr o m t o xicit y, t he c ycle le n gt h ma y be 
e xte n de d u p t o 2 8 da ys (ie, 7 -da y treat me nt free i nter val starti n g o n Da y 2 1). 
d.
C R is defi ne d as < 5 % blasts i n t he b o ne marr o w a n d t he a bse nce of peri p heral bl o o d le u ke mic blasts, f ull rec o ver y 
of peri p heral bl o o d c o u nts ( platelets 1 0 0 × 1 0 9/ L a n d a bs ol ute ne utr o p hil c o u nts [ A N C] 1 × 1 0 9/ L) a n d res ol uti o n 
of a n y e xtra me d ullar y disease. 
e.
C Ri is defi ne d as < 5 % blasts i n t he b o ne marr o w a n d t he a bse nce of peri p heral bl o o d le u ke mic blasts, i nc o m plete 
rec o ver y of peri p heral bl o o d c o u nts ( platelets < 1 0 0 × 1 09/ L a n d/ or A N C < 1 × 1 0 9/ L) a n d res ol uti o n of a ny 
e xtra me d ullar y disease. 
f.
7- da y treat me nt free i nter val starti n g o n Da y 2 1. 
I nf usi o ns of i n ot uz u ma b oz o ga mici n m ust be c o m plete d acc or di n g t o ti me fra mes 
s pecifie d i n t he I P ma n ual.
6. 2. Pre p ar ati o n/ H a n dli n g/ St or a ge/ Acc o u nt a bilit y
1.
T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, te m perat ure) 
ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns recei ve d a n d a n y 
discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y  i nter ve nti o n. 
2.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y  s u p pl y, pre pare, a n d/ or a d mi nister st u d y i nter ve nti o n.  
3.
All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d 
m o nit ore d ( ma n ual or a ut o mate d rec or di n g) area i n acc or da nce wit h t he la bele d st ora ge 
c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d a ut h orize d site staff.  At a 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 4 9
mi ni m u m, dail y  mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge l ocati o ns m ust 
be d oc u me nte d a n d a vaila ble u p o n re q uest.  Data f or n o n w or ki n g da y s m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat ures si nce pre vi o usl y  d oc u me nte d u p o n ret ur n t o 
b usi ness.
4.
A n y e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be re p orte d t o 
Pfizer u p o n disc o ver y  al o n g wit h a ny acti o ns ta ke n.  T he site s h o ul d acti vel y  p urs ue 
o pti o ns f or ret ur ni n g t he st u d y  i nter ve nti o n t o la bele d st ora ge c o n diti o ns, as s o o n as 
p ossi ble.  O nce a n e xc ursi o n is i de ntifie d, t he st u d y  i nter ve nti o n m ust be q uara nti ne d a n d 
n ot use d u ntil Pfizer pr o vi des per missi o n t o use t he st u d y  i nter ve nti o n. S pecific details 
re gar di n g t he e xc ursi o n defi niti o n a n d i nf or mati o n t o re p ort f or eac h exc ursi o n will be 
pr o vi de d t o t he site i n t he I P ma n ual .
5.
A n y  st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge c o n diti o ns 
state d o n t he la bel. See t he IP ma n ual f or i nstr ucti o ns h o w t o pre pare in ot uz u ma b
oz o ga mici n f or a d mi nistrati o n.
6.
St u d y  i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners.
7.
T he i n vesti gat or, i nstit uti o n, hea d of t he me dical i nstit uti o n ( w here a p plica ble), or 
a ut h orize d site staff is res p o nsi ble f or st u d y  i nter ve nti o n acc o u nta bilit y, rec o nciliati o n, 
a n d rec or d mai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal dis p ositi o n rec or ds), s uc h as 
t he IP A L or s p o ns or -a p pr o ve d e q ui vale nt.  All st u d y i nter ve nti o ns will be acc o u nte d f or 
usi n g a st u d y i nter ve nti o n acc o u nta bilit y f or m/rec or d . 
8.
F urt her g ui da nce a n d i nf or ma ti o n f or t he fi nal dis p ositi o n of u n use d st u d y i nter ve nti o ns 
are pr o vi de d i n t he i n vesti gati o nal pr o d uct ma n ual (IP ma n ual). All destr ucti o n m ust be 
a de q uatel y d oc u me nte d. If destr ucti o n is a ut h orize d t o ta ke place at t he i n vesti gat or site, 
t he i n vesti gat or m ust e ns ure t hat t he materials are destr o ye d i n c o m plia nce wit h 
a p plica ble e n vir o n me ntal re g ulati o ns, i nstit uti o nal p olic y , a n d a n y s pecial i nstr ucti o ns 
pr o vi de d b y Pfizer.
9.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or wit hi n 1 b usi ness da y  of 
disc o ver y  as descri be d i n t he IP ma n ual.
6. 2. 1. Pre p ar ati o n a n d Dis pe nsi n g
See t he I n vesti gati o nal Pr o d uct Ma n ual f or i nstr ucti o ns o n h o w t o pre pare i n ot uz u ma b 
oz o ga mici n f or a d mi nistrati o n.  I n ot uz u ma b oz o ga mici n s h o ul d be pre pare d a n d dis pe nse d 
b y  a n a p pr o priately q ualifie d a n d e x perie nce d me m ber of t he st u d y staff (e g, p h ys icia n, 
n urse, p h ys icia n’s assista nt, n urse practiti o ner, p har mac y assista nt/tec h nicia n, or p har macist) 
as all o we d b y l ocal, state, a n d i nstit uti o nal g ui da nce.  O nl y q ualifie d pers o n nel w h o are 
fa miliar wit h pr oce d ures t hat mi ni mize u n d ue e x p os ure t o t he msel ves a n d t o t he e n vir o n me nt 
s h o ul d u n derta ke t he pre parati o n, ha n dli n g, a n d safe dis p osal of c he m ot hera pe utic a ge nts.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 0
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
T his is a n o pe n -la bel, si n gle-ar m st u d y; ra n d o mizati o n c o des will be distri b ute d t o sites 
ma n uall y  b y s p o ns or, a n d t he i n vesti gat ors at t he sites will rec or d t he ra nd o mizati o n c o des o n 
t he C R F.  T he i n vesti gat or’s k n o wle d ge of t he treat me nt s h o ul d n ot i nfl ue nce t he decisi o n t o 
e nr oll a partic ular partici pa nt or affect t he or der i n w hic h partici pa nts are e nr olle d.
I n vesti gati o nal pr o d uct will be dis pe nse d at t he st u d y visits s u m marize d i n t he S o A . 
Ret ur ne d i n vesti gati o nal pr o d uct m ust n ot be re dis pe nse d t o t he partici pa nts.
6. 4. B li n di n g
T his is a n o pe n -la bel st u d y.
6. 5. St u d y I nter ve nti o n C o m pli a nce
All d oses of i n vesti gati o nal pr o d uct will be a d mi nistere d b y  t he a p pr o priatel y desi g nate d 
st u d y staff at t he i n vesti gat or site.
T he site will c o m plete t he re q uire d d osa ge Pre parati o n Rec or d l ocate d i n t he IP M.  T he use 
of t he Pre parati o n Rec or d is preferre d, b ut it d oes n ot precl u de t he use of a n e xisti n g 
a p pr o priate cli nical site d oc u me ntati o n s y ste m. T he e xisti n g cli nical site's d oc u me ntati o n 
s yste m s h o ul d ca pt ure all perti ne nt/re q uire d i nf or mati o n o n t he pre parati o n a n d 
a d mi nistrati o n of t he d ose.  T his ma y be use d i n place of t he Pre parati o n Rec or d after 
a p pr o val fr o m t he s p o ns or a n d/ or desi g nee.
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he date a n d ti me of eac h d ose 
a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce d oc u me nts a n d rec or de d i n t he C R F.  
T he d ose of st u d y i nter ve nti o n a n d st u d y partici pa nt i de ntificati o n will be c o nfir me d at t he 
ti me of d osi n g by a me m ber of t he st u d y site staff ot her t ha n t he pers o n a d mi nisteri n g t he 
st u d y i nter ve nti o n.
6. 6. D ose M o dific ati o n 
6. 6. 1. Rec o m me n de d D ose M o dific ati o ns
E ver y eff ort s h o ul d be ma de t o a d mi nister s t u d y treat me nt o n t he pla n ne d d ose a n d sc he d ule. 
I n t he e ve nt of t o xicit y, d osi n g m a y b e dela y e d as descri be d bel o w.  I n t he e ve nt of m ulti ple
t o xicities, d ose m o dificati o n s h o ul d be base d o n t he w orst t o xicit y o bser ve d.  Patie nts are t o 
be i nstr ucte d t o n otif y  I nvesti gat ors at t he first occ urre nce of a n y a d verse s ym pt o m.
D ose m o dificati o ns ma y occ ur as f oll o ws:
Wit hi n a c y cle: d ose i nterr u pti o n u ntil a de q uate rec o ver y  or o missi o n of a d ose d uri n g a 
gi ve n treat me nt c y cle. Bet wee n c y cles: ne xt c ycle a d mi nistrati o n ma y be p ost p o ne d d ue t o 
t o xicit y i n t he pre vi o us c ycle. I n t he ne xt c ycle: d ose re d ucti o n base d o n w orst t o xicit y 
o bser ve d i n t he pre vi o us c y cle.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 1
6. 6. 2. D ose Re d ucti o ns
D ose re d ucti o ns ma y  be re q uire d base d o n t he w orst t o xicit y e x perie nce d i n t he pre vi o us
c ycle.  D ose re d ucti o ns or o missi o ns of dr u g s h o ul d be base d o n i nstit uti o nal g ui deli nes or 
sta n dar d of care.  Patie nts e x perie nci n g a treat me nt i nterr u pti o n d ue t o test article-relate d 
t o xicit y ≥1 4 da y s will res u me d osi n g wit h a si n gle 2 5 % re d ucti o n i n i n ot uz u ma b oz o ga mici n 
f or t he s u bse q ue nt c ycle ( 0. 5 m g/ m 2, t o 0. 3 7 5 m g/ m2) o nce a de q uate rec o ver y is ac hie ve d.  If 
f urt her d ose m o dificati o n is i n dicate d after a 2 5 % d ose re d ucti o n, t he n u m ber of d oses wit hi n 
t he c ycle s h o ul d be re d uce d t o t w o f or s u bse q ue n t c ycles.  D ose re d ucti o n of i n ot uz u ma b 
oz o ga mici n b y 2 5 % is rec o m me n de d f or patie nts wit h C Ri, w h ose platelet c o u nts ha ve n ot 
rec o vere d t o t h ose val ues o btai ne d pri or t o t he start of t he pre vi o us c ycle.
O nce a partici pa nt has a d ose re d ucti o n f or a dr u g -relate d t o xicit y, t he d ose will n ot be re-
escalate d. Partici pa nts w h o are u na ble t o t olerate a 2 5 % d ose re d ucti o n f oll o we d b y a
decrease i n t he n u m ber of d oses per c ycle t o t w o d oses will be wit h dra w n fr o m treat me nt
u nless ot her wise a gree d bet wee n t h e i n vesti gat or a n d t he s p o ns or.
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
N o i nter ve nti o n will be pr o vi de d t o st u d y partici pa nts at t he e n d of t he st u d y .
6. 8. Tre at me nt of O ver d ose
F or t his st u d y , a n y d ose of i n ot uz u ma b oz o ga mici n greater t ha n t he 1 1 0 % of 0. 8 m g/ m 2
wit hi n a 2 4 -h o ur ti me peri o d 2 h o urs will be c o nsi dere d a n o ver d ose.
T here is n o s pecific a nti d ote f or a n o ver d ose of i n ot uz u ma b oz o ga mici n a n d treat me nt of 
o ver d ose s h o u l d t heref ore c o nsist of ge neral s u p p orti ve meas ures.
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d:
1.
C o ntact t h e st u d y me dical m o nit or wit hi n 2 4 h o urs.
2.
Cl osel y  m o nit or t he partici pa nt f or a ny A Es/ S A Es a n d la b orat or y  a b n or malities u ntil 
i n ot uz u ma b oz oga mici n ca n n o l o n ger be detecte d s y ste mically (at least 9 wee ks) .
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n 
t he C R F.
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nl y w he n ass oci ate d wit h a n S A E .
Decisi o ns re gar di n g d ose i nterr u pti o ns or m o dificati o ns will be ma de b y  t he i n vesti gat or i n 
c o ns ultati o n wit h t he me dical m o nit or base d o n t he cli nical e val uati o n of t he partici pa nt.
O ver d ose will be rec or de d i n t he C R F relate d pa ge.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 2
6. 9. Pri or a n d C o nc o mit a nt T her a p y
6. 9. 1. C o nc o mit a nt Me dic ati o ns
T he start date, st o p date, a n d i n dicati o n f or all c o nc o mita nt treat me nts a n d/ or t hera pies, 
i ncl u di n g vacci nes, bl o od pr o d ucts, as well as n o n dr u g i nter ve nti o ns recei ve d b y  partici pa nts 
fr o m scree ni n g u ntil 4 wee ks after t he last d ose of i n vesti gati o nal pr o d uct (ie, t hr o u g h e n d of 
treat me nt visit) will be rec or de d o n t he case re p orts f or m ( C R F).  Treat me nt a n d/ or t hera pies 
f or a d verse e ve nts will be rec or de d o n t he C R F u p t hr o u g h 9 wee ks after t he last d ose of 
i n ot uz u ma b oz o ga mici n (see Secti o n 1. 3 ).  I n t he F oll o w-u p peri o d, select c o nc o mita nt 
me dicati o ns i ncl u di n g a ntif u n gals, pr o p h yl a xis/treat me nt f or G v H D , a n d 
pr o p h y la xis/treat me nt f or V O D (i ncl u di n g urs o de o x yc h olic aci d or defi br oti de) will be 
c ollecte d i n t he C RF f or u p t o at least 1 0 0 d a y s after a s u bse q ue nt H S C T (Secti o n 1. 3 ).  Als o, 
i n case of se vere li ver t o xicit y f oll o wi n g s u bse q ue nt H S C T warra nti n g a n S A E re p ort, 
i ncl u de details re gar di n g t hese c o nc o mita nt me dicati o ns s uc h as the act ual d ose use d, start 
a n d st o p dates a n d cli nical res p o nse t o t heir use.  Data c ollecte d i n t he c o nte xt of t heir use 
will be pr o vi de d as part of t he fi nal cli nical st u d y re p ort.
6. 9. 2. Per mitte d C o nc o mit a nt Me dic ati o ns
A n y  me dicati o n f or a c o nc urre nt me dical c o n diti o n is per mitte d a n d will be s u p plie d b y  t he 
st u d y site.
D uri n g t he treat me nt peri o d, t he use of h y dr o x y urea is per mitte d f or te m p orar y c o ntr ol of 
W B C ele vati o ns i n patie nts wit h a g gressi ve disease b ot h pri or a n d d uri n g t he first 5
d a y s of 
st u d y treat me nt.  Re d ucti o n of peri p heral blast c o u nts t o at least 1 0, 0 0 0 /L is re q uire d f or 
e nr oll me nt a n d ma y i m pr o ve t he i nitial P K pr ofile of i n ot uz u ma b oz o ga mici n.  H ydr o x y urea 
ma y  be gi ve n at 1 t o 5 gra ms dail y  f or u p t o 5 da ys i n C y cle 1.
C o nc urre nt t hera p y f or C N S pr o p h yla xis/treat me nt is str o n gl y e nc o ura ge d (e g, i ntrat hecal 
met h otre xate).
Gr o wt h fact ors s uc h as gra n ul oc y te c ol o n y sti m ulati n g fact or (G- C S F ), i ncl u di n g 
pe gfil grasti m, a n d gra n ul oc y te macr o p ha ge c ol o n y sti m ulati n g fact or ( G M -C S F ) ma y be 
use d i n acc or da nce wit h l ocal g ui deli nes a n d me dical practice.
Platelet tra nsf usi o ns s h o ul d be gi ve n if cli nicall y i n dicate d b ut ca n n ot be use d t o meet d osi n g 
criteria pri or t o t he start of s u bse q ue nt c ycles.
C ortic oster oi ds are all o we d f or c y t ore d ucti o n, C N S pr op h y la xis/treat me nt, as pre me dicati o n
f or u p t o 1 da y, t o treat h yperse nsiti vit y  reacti o ns f or u p t o 1 da y, a n d as a ntie metic f or u p t o 
8 da y s/c ycle as s u p p orti ve care.  I ntra nasal, i n hale d, or t o pical c ortic oster oi ds are all o we d, as 
are l o w d oses of c orticoster oi ds ( 1 0 m g  or less of pre d nis o ne or e q ui vale nt/ da y) t hr o u g h o ut 
st u d y partici pati o n.  Hi g her d oses of ster oi ds are disc o ura ge d if alter nati ve t hera py is 
a vaila ble.  It is cr ucial t o e nter d osi n g details f or s y ste mic c ortic oster oi ds a d mi nistere d i n t he
C R F d ue t o t heir p ossi ble i nfl ue nce o n t he st u d y e n d p oi nts.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 3
6. 9. 3. Pr o hi bite d C o nc o mit a nt Me dic ati o ns
Cra ni os pi nal ra diati o n ( C S X R T) is pr o hi bite d d uri n g st u d y  treat me nt.  If C S X R T is cli nicall y 
i n dicate d, t he patie nt s h o ul d be wit h dra w n fr o m st u d y t hera p y.
A nti- ca ncer t hera p y ot her t ha n as defi ne d/all o we d i n t his pr ot oc ol a n d ot her i n vesti gati o nal 
a ge nts are pr o hi bite d t hr o u g h o ut t he treat me nt peri o d of t he st u d y .
6. 9. 4. Disc o ur a ge d C o nc o mit a nt Me dic ati o ns
Patie nts s h o ul d be str o n gl y  e nc o ura ge d t o a v oi d her bal s u p ple me nts t hr o u g h o ut t he treat me nt 
peri o d of t he st u d y.
C o nc o mita nt use of i n ot uz u ma b oz o ga mici n wit h dr u gs k n o w n t o pr ol o n g t he Q T i nter val or 
i n d uce T orsa des de P oi ntes ma y i ncrease t he ris k of a cli nically si g nifica nt Q Tc i nter val 
pr ol o n gati o n.  Disc o nti n ue or use alter nati ve c o nc o mita nt dr u gs t hat d o n ot pr ol o n g Q T/ Q Tc 
i nter val d uri n g i n ot uz u ma b oz o ga mici n treat me nt.  W he n it is n ot feasi ble t o a v oi d 
c o nc o mita nt use of dr u gs k n o w n t o pr ol o n g Q T/ Q Tc, o btai n E C Gs a n d electr ol ytes pri or t o 
t he start of treat me nt, after i nitiati o n of a n y dr u g k n o w n t o pr ol o n g Q Tc, a n d peri o dically 
m o nit or as cli nicall y i n dicate d d uri n g treat me nt.  See Secti o n 1 0. 8 , A p pe n di x 8 f or a list of 
me dicati o ns.
At cli nicall y  rele va nt c o nce ntrati o ns, N- acet yl -ga m ma -calic hea mici n ( w hic h is release d fr o m 
i n ot uz u ma b oz o ga mici n f oll o wi n g hy dr ol yt ic clea va ge of t he A D C li n ker) ha d a l o w 
p o te ntial t o i n hi bit or i n d uce c yt oc hr o me P 4 5 0 e nz ymes, i n hi bit uri di ne 
gl uc ur o n yl tra nsferase ( U G T) e nz ymes, or i n hi bit dr u g tra ns p orters ( p -gl yc o pr otei n, breast 
ca ncer resista nce pr otei n ( B C R P), or ga nic a ni o n tra ns p orter ( O A T) 1 a n d O A T 3, or ga nic 
cati o n tra n s p orter ( O C T) 2, a n d or ga nic a ni o n tra ns p orti n g p oly pe pti de ( O A T P) 1 B 1 a n d 
O A T P 1 B 3.  At cli nicall y rele va nt c o nce ntrati o ns, i n ot uz u ma b oz o ga mici n ha d a l o w 
p ote ntial t o i n hi bit or i n d uce c y t oc hr o me P 4 5 0 e nz ymes.
6. 9. 5. Resc ue Me dici ne
T here is n o resc ue t hera p y t o re verse t he A Es o bser ve d wit h i n ot uz u ma b oz o ga mici n; 
sta n dar d me dical s u p p orti ve care m ust be pr o vi de d t o ma na ge A Es.
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
Per t he st u d y  esti ma n ds, if i n vesti gati o nal pr o d uct is per ma ne ntl y disc o nti n ue d, t he 
partici pa nt will re mai n i n t he st u d y  a n d c o nti n ue t o be f oll o we d f or pr ot oc ol s pecifie d f oll o w 
u p pr oce d ures.  T he o nl y e xce pti o n t o t his is w he n a patie nt s pecificall y  wit h dra ws c o nse nt 
f or a n y f urt her c o ntact wit h hi m or her or pers o ns pre vi o usl y a ut h orize d b y t he patie nt t o 
pr o vi de t his i nf or mati o n. 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 4
It ma y be necessar y f or a partici pa nt t o per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt disc o nti n uati o n of st u d y i nter ve nti o n i ncl u de t he f oll o wi n g:

O bjecti ve disease pr o gressi o n;

L ac k of efficac y

Gl o bal deteri orati o n of healt h stat us re q uiri n g disc o nti n uati o n;

U nacce pta ble t o xicit y ;

Pre g na nc y ;

Si g nifica nt pr ot oc ol vi olati o n;

L ost t o f oll o w - u p;

Partici pa nt ref use d f urt her treat me nt;

St u d y  ter mi nate d b y s p o ns or;

Deat h.
N ote t hat disc o nti n uati o n of st u d y  i nter ve nti o n d oes n ot re prese nt wit h dra wal fr o m t he st u d y. 
If st u d y i nter ve nti o n is per ma ne ntly disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y 
t o be e val uate d f or safety, disease assess me nts, s u bse q ue nt a ntica ncer t hera pies, a n d s ur vi val . 
See t he S o A f or data t o be c ollecte d at t he ti me of disc o nti n uati o n of st u d y i nter ve nti o n a n d 
f oll o w-u p a n d f or a n y f urt her e val uati o ns t hat nee d t o be c o m pl ete d.
I n t he e ve nt of disc o nti n uati o n of st u d y i nter ve nti o n, it m ust be d oc u me nte d o n t he 
a p pr o priate C R F/i n t he me dical rec or ds w het her t he partici pa nt is disc o nti n ui n g f urt her \
recei pt of st u dy i nter ve nti o n or als o fr o m st u d y  pr oce d ures, p osttreat me nt stu d y  f oll o w- u p, 
a n d/ or f ut ure c ollecti o n of a d diti o nal i nf or mati o n.
F oll o wi n g t he disc o nti n uati o n fr o m t he treat me nt, patie nts will be f oll o we d f or:
1.
D isease pr o gressi o n f or u p t o 2 years fr o m t he first d ose, u nless t he disease 
pr o gresse d d uri n g t he treat me nt.
2.
P ote ntial V O D/ S O S cases, irres pecti ve of gra de or ca usalit y  f or u p t o 2 years fr o m 
t he first d ose.
3.
S ur vi val f or u p t o 2 years fr o m t he first d ose.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 5
7. 1. 1. Te m p or ar y Disc o nti n u ati o n 
7. 1. 1. 1. Re d osi n g Criteri a a n d D ose Del a ys
U nless patie nts meet t he f oll o wi n g criteria pri or t o t he start of eac h c y cle, all st u d y t hera py 
will be dela y e d.
1.
N o e vi de nce of pr o gressi ve disease.  See A p pe n di x 7 f or o utc o me defi niti o ns.  St u d y 
treat me nt ma y be c o nti n ue d i n patie nts wit h is olate d C N S rela pse, at t he i n vesti gat or’s 
discreti o n.
2.
Decrease i n blast perce nta ge or sta ble disease (ie, n ot m ore t ha n a 5 0 % i ncrease i n blast
perce nta ge) base d o n t he m ost rece nt peri p heral bl o o d c o u nts a n d b o ne marr o w 
e val uati o n.
3.
Rec o ver y  t o gra de 1 or baseli ne f or n o n-he mat ol o gic st u d y i nter ve nti o n-relate d t o xicit y 
(e xce pt al o pecia) ( pri or t o eac h d ose of i n ot uz u ma b oz o ga mici n).
4.
T otal ser u m bilir u bi n ≤1. 5 × U L N ( or if ele vate d d ue t o t u m or, t otal ser u m bilir u bi n ≤2 × 
U L N), a n d A S T, A L T ≤2. 5 × U L N irres pecti ve of t he ca usalit y ( pri or t o eac h d ose of 
i n ot uz u ma b oz o ga mici n).  E xce pti o n: H yper bilir u bi ne mia i n t he setti n g of d oc u me nte d 
Gil bert’s s y n dr o me or he m ol y sis.
5.
Ser u m creati ni ne ≤2 × U L N or esti mate d creati ni ne cleara nce ≥4 0 m L / mi n as calc ulate d 
usi n g t he met h o d sta n dar d f or t he i nstit uti o n ( pri or t o eac h d ose of i n ot uz u ma b 
oz o ga mici n).
6.
F or patie nts wit h pre -treat me nt ( C 1 D 1) a bs ol ute ne utr o p hil c o u nt ( A N C) ≥1 × 1 0 9/ L: 
A N C ≥1 × 1 0 9/ L.
7.
F or patie nts wit h pre -treat me nt ( C 1 D 1) platelets ≥5 0 × 1 0 9/ L: platelets ≥5 0 × 1 0 9/ L.
8.
F or patie nts wit h baseli ne A N C < 1 × 1 0 9/ L a n d/ or platelets < 5 0 × 1 09/ L: A N C a n d 
platelets m ust rec o ver at least t o baseli ne val ues o btai ne d f or t he last c y cle, or A N C 
≥1 × 1 0 9/ L a n d platelets ≥5 0 × 1 0 9/ L, or t he m ost rece nt b o ne marr o w m ust de m o nstrate 
sta ble or i m pr o ve d disease, a n d t he A N C a n d platelets are belie ve d t o be l o w d ue t o 
disease, n ot i n vesti gati o nal pr o d uct.
9.
Q Tc F ≤4 7 0 msec (a vera ge of 3 E C Gs).  N ote: Q Tc F m ust be c o nfir me d pri or t o d osi n g 
o n Da y 1 of C ycles 1, 2 a n d 4 o nl y  (irres pecti ve of t he ca usalit y, d osi n g m ust be hel d if 
a vera ge Q Tc F > 4 7 0 msec).
1 0. A n y  h yp ocalce mia, h y p o kale mia, or h y p o ma g nese mia m ust be c orrecte d acc or di n g t o 
sta n dar d of care pri or t o d osi n g.
W hile d oses gi ve n wit hi n a treat me nt c y cle (ie, Da ys 8 a n d/ or 1 5) nee d n ot be dela ye d d ue t o 
ne utr o pe nia or t hr o m b oc y t o pe nia, d ose dela ys wit hi n a c ycle are re q uire d f or n o n -
he mat ol o gic t o xicit y  (see #s 3 , 4 , 5 , 9 , a n d 1 0 a b o ve).  Platelet tra nsf usi o ns s h o ul d be gi ve n if 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 6
cli nicall y i n dicate d b ut ca n n ot be use d t o meet d osi n g criteria pri or t o t he start of s u bse q ue nt 
c ycles.
I n ot uz u ma b oz o ga mici n d osi n g s h o ul d be per ma ne ntl y disc o nti n ue d f or a n y patie nt wit h 
p ossi ble, pr o ba ble or c o nfir me d V O D/ S O S or ot her se vere li ver t o xicit y .  F or i n ot uz u ma b 
oz o ga mici n, d ose dela ys d ue t o test article -relate d t o xicit y ≤7 da y s d uri n g a treat me nt c ycle 
are per mitte d.  If d ose dela y  is > 7 da ys, it will res ult i n o missi o n of t he ne xt d ose wit hi n t he 
c ycle; t he patie nt re mai ns eli gi ble t o recei ve t he s u bse q ue nt pla n ne d d ose ass u mi n g all 
d osi n g criteria are met.  If a d ose wit hi n a c y cle is dela ye d (ie, Da y 8 or 1 5 d ose is dela ye d), 
t he ne xt d ose s h o ul d als o be dela ye d.  A mi ni m u m of 6 da ys s h o ul d be mai ntai ne d bet wee n 
d oses.  Reas o n f or a n y d ose dela y s m ust be re p orte d o n d osi n g C R F.  If a treat me nt 
i nterr u pti o n c o nti n ues be yo n d Da y  2 8 of t he c urre nt c ycle, t he n t he da y w he n treat me nt is 
restarte d will be c o nsi dere d Da y 1 of t he ne xt c y cle.  If t he be gi n ni n g of t he ne xt c ycle is 
dela y e d b y m ore t ha n 2 8 da ys d ue t o test article -relate d t o xicit y/ies (D ela y of Da y 1 d osi n g 
be y o n d 4 2 da y s fr o m pri or c ycle Da y 1 5 d osi n g) , st u d y  treat me nt will be per ma ne ntly 
disc o nti n u e d u nless ot her wise a gree d b y s p o ns or a n d i n vesti gat or.  All t o xicit y gra des are 
acc or di n g t o Nati o nal Ca ncer I nstit ute versi o n 5. 0 ( N CI C T C A E v 5. 0).
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al Fr o m t he St u d y 
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny time at his/ her o w n re q uest. Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y i ncl u de t he f oll o wi n g: 

Wit h dra wal b y  partici pa nt;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter mi nate d b y s p o ns or.
At t he ti me of disc o nti n ui n g fr o m t he st u d y, if p ossi ble, a n earl y disc o nti n uati o n visit s h o ul d 
be c o n d ucte d.  See t he S o A f or assess me nts t o be c ollecte d at t he ti me of st u d y 
disc o nti n uati o n a n d f oll o w- u p a n d f or a n y f urt her e val uati o ns t hat nee d t o be c o m plete d. 
T he earl y disc o nti n uati o n visit a p plies o nl y t o partici pa nts w h o are e nr olle d a n d t he n are 
pre mat urel y wit h dra w n fr o m t he st u d y.  Partici pa nts s h o ul d be q uesti o ne d re gar di n g t heir 
reas o n f or wit h dra wal.  
T he partici pa nt will be per ma ne ntl y disc o nti n ue d fr o m t he st u d y i nter ve nti o n a n d t he st u d y  at 
t hat ti me.
If a partici pa nt wit h dra ws fr o m t he st u d y, he/s he ma y  re q uest destr ucti o n of a n y re mai ni n g 
sa m ples ta ke n a n d n ot teste d, a n d t he i n vesti gat or m ust d oc u me nt a n y s uc h re q uests i n t he 
site st u d y rec or ds a n d n otif y t he s p o ns or acc or di n gl y.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 7
If t he partici pa nt wit h dra ws fr o m t he st u d y  a n d als o wit h dra ws c o nse nt (see Secti o n 7. 2. 1 ) 
f or discl os ure of f ut ure i nf or mati o n, n o f urt her e val uati o ns will be perf or me d a n d n o 
a d diti o nal data will be c ollecte d.  T he s p o ns or ma y  retai n a n d c o nti n ue t o use a n y data 
c ollecte d bef ore s uc h wit h dra wal of c o nse nt.
7. 2. 1. Wit h dr a w al of C o nse nt: 
Partici pa nts w h o re q uest t o disc o nti n ue recei pt of st u d y  i nter ve nti o n will re mai n i n t he st u d y 
a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol s pecifie d f oll o w- u p pr oce d ures.  T he o nly 
e xce pti o n t o t his is w he n a partici pa nt s pecificall y wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h hi m or her or pers o ns pre vi o usl y  a ut h orize d b y t he partici pa nt t o pr o vi de t his 
i nf or mati o n.  Partici pa nts s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o 
wit h dra w c o nse nt fr o m f ut ure f oll o w- u p, w he ne ver p ossi ble.  T he wit h dra wal of c o nse nt 
s h o ul d be e x plai ne d i n detail i n t he me dical rec or ds b y t he i n vesti gat or, as t o w het her t he 
wit h dra wal is o nl y  fr o m f urt her recei pt of st u dy i nter ve nti o n or als o fr o m st u d y pr oce d ures 
a n d/ or p osttreat me nt st u d y f oll o w-u p, a n d e ntere d o n t he a p pr o priate C R F pa ge.  I n t he e ve nt 
t hat vital stat us ( w het her t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicl y 
a vaila ble i nf or mati o n s h o ul d be use d t o deter mi ne vital stat us o nl y  as a p pr o priatel y directe d 
i n acc or da nce wit h l ocal la w.
7. 3. L ost t o F oll o w -u p 
A partici pa nt will be c o nsi dere d l ost t o f oll o w- u p if t he partici pa nt re peate dl y  fails t o ret ur n 
f or sc he d ule d visits a n d is u na ble t o be c o ntacte d b y t he st u d y site.
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o ret ur n t o t he cli nic f or a re q uire d 
st u d y visit:
T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as 
s o o n as p ossi ble a n d co u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule, a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or 
s h o ul d c o nti n ue i n t he st u d y;
Bef ore a partici pa nt is dee me d l ost t o f oll o w- u p, t he i n vesti gat or or desi g nee m ust 
ma ke e ver y  eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 
tele p h o ne calls a n d, if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n 
maili n g a d dress or l ocal e q ui vale nt met h o ds).  T hese c o ntact atte m pts s h o ul d be 
d oc u me nte d i n t he partici pa nt’s me dical rec or d;
S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, t he partici pa nt will be c o nsi dere d 
t o ha ve wit h dra w n fr o m t he st u d y. 
Disc o nti n uati o n of s pecific sites or of t he st u d y  as a w h ole is ha n dle d as part of Secti o n 1 0. 1   
A p pe n di x 1 .
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 8
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
8. 1. A d mi nistr ati ve Pr oce d ures
T he i n vesti gat or ( or a n a p pr o pri ate dele gate at t he i n vesti gat or site) m ust o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y st u d y s pecific pr oce d ures.  
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A .  Pr ot oc ol wai vers or 
e xe m pti o ns are n ot all o we d .
A d here nce t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A , is esse ntial 
a n d re q uire d f or st u d y c o n d uct.
All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bilit y criteria.  T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or 
scree ni n g fail ure, as a p plica ble.
Pr oce d ures c o n d ucte d as part of t he partici pa nt’s sta n dar d of care a n d o btai ne d bef ore 
si g ni n g of t he I C D ma y be utilize d f or eli gi bilit y pr o vi de d t he pr oce d ures met t he pr ot oc ol
s pecifie d criteria a n d were perf or me d wit hi n t he ti me fra me defi ne d i n t he S o A .
E v er y eff ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d.  H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y  be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma y  ma ke it u nfeasi ble t o perf or m 
t he test.  In t hese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y  t o e ns ure t he safety a n d 
well -bei n g of t he partici pa nt.  W he n a pr ot oc ol re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a n y c orrecti ve a n d pre ve nti ve 
acti o ns t hat he or s he has ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble.  T he st u d y  tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p me nt i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y.
8. 2. Effic ac y Assess me nts
Assess me nt of res p o nse a n d pr o gressi o n stat us will be e val uate d acc or di n g t o a m o difie d
C hes o n Criteria descri be d i n Secti o n 1 0. 7   A p pe n di x 7 .  Disease assess me nts are deter mi ne d 
usi n g i nf or mati o n fr o m b o ne marr o w e val uati o ns, la b orat or y assess me nts (e g, he mat ol o g y ),
cli nical a n d ra di ol o gical i nf or mati o n (e g, e xtra me d ullar y disease).   N o b o ne marr o w as pirate 
is necessar y if n o n -res p o nse or pr o gressi ve disease ca n be dia g n ose d fr o m peri p heral bl o o d
e val uati o n or ra di ol o gical/cli nical assess me nt.  Patie nts wit h e x tra me d ullar y disease pri or t o
first d ose will ha ve ra di o gra p hic assess me nt (c o m p ute d t o m o gra p h y [ C T] or ma g netic 
res o na nce i ma gi n g [ M RI]) t o c o nfir m a C R or C Ri usi n g t he sa me met h o d of assess me nt, 
u nless c o ntrai n dicate d.  C T sca n wit h c o ntrast is t he preferre d met h o d of assess me nt.  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 5 9
B o ne marr o w as pirates ( or bi o psies if cli nicall y i n dicate d) a n d disease assess me nts ( See 
Secti o n 1 0. 7 , A p pe n di x 7 ) will be perf or me d at scree ni n g, at da y 1 6 - 2 8 of c ycles 1, 2 or u ntil 
C R/ C Ri a n d M R D ne gati vit y  are ac hie ve d. T he n aft er e ver y 1, 2 c y cles as cli nicall y i n dicate d, 
a n d at e n d-of -treat me nt ( E O T) visit ( u nless pre vi o usl y d o ne wit hi n 2 8 da ys). 
B o ne marr o w as pirates will be a nal yze d at t he st u d y site.  A b o ne marr o w ( B M) bi o ps y will
be d o ne i n patie nts ac hie vi n g C Ri b y  t he i n vesti gat or’s assess me nt t o e val uate cell ularit y.
C o m plete bl o o d c o u nt ( C B C) wit h differe ntial a n d platelets, b o ne marr o w as pirate, b o ne 
marr o w bi o ps y as cli nicall y i n dicate d, pl us re-e val uati o n of pre -e xisti n g or s us pecte d 
e xtra me d ullar y disease as cli nicall y i n dicate d s h o ul d be c o m plete d at t he ti me of eac h
disease assess me nt. If a C N S disease assess me nt was i n dicate d d uri n g scree ni n g, 
reassess me nts will be d o ne as cli nically i n dicate d.  (Ta ble 1 ).
At a n y ti me p oi nt, a n a d diti o nal as pirate or bi o psy ma y be re q uire d if t he ori gi nal as pirate is
i na de q uate f or disease assess me nt.
F or patie nts re q uiri n g baseli ne c yt ore d ucti o n or palliati o n (e g, h y dr o x y urea, ster oi ds
a n d/ or vi ncristi ne), a p ost -c yt ore d ucti o n B M assess me nt is n ot re q uire d pri or t o
e nr oll me nt.
If a patie nt recei ves a m ore a g gressi ve c he m ot hera p y re gi me n (ie, a n ot her sal va ge
atte m pt), t he patie nt m ust re peat t he e ntire scree ni n g pr ocess a n d m ust meet all
eli gi bilit y criteria pri or t o e nr oll me nt.
G- C S F s h o ul d be disc o nti n ue d at least 7 2 h o urs pri or t o e ver y b o ne marr o w
assess me nt .
I m m u n o p he n oty pi n g b y fl o w c yt o metr y will be perf or me d i n all patie nts at scree ni n g a n d 
will be d o ne i n patie nts wit h s us pecte d C R a n d/ or C Ri . T he le u ke mia p he n ot ype a n d/ or 
ge n ot y p e ma y als o be e val uate d b y ot her test met h o ds at t he discreti o n of t he i n vesti gat or.
Fl u oresce nce i n sit u h y bri dizati o n ( FI S H) a nal ys is ma y be d o ne i n all patie nts at scree ni n g.
Kar y ot y pi n g will be perf or me d i n all patie nts at scree ni n g a n d at least o nce i n patie nts 
ac hie vi n g m or p h ol o gic C R or C Ri a n d w h o ha d a b n or mal c y t o ge netics at baseli ne.  It is 
rec o m me n de d t hat 2 0 or m ore meta p hases be c o u nte d f or l ocal c yt o ge netics a nal ysis.
O S is t he ti me fr o m t he first da y of t he first c ycle t o date of deat h d ue t o a n y ca use.  
Ce ns ors hi p: Patie nts last k n o w n t o be ali ve are ce ns ore d at date of last c o ntact.
F or deter mi nati o n of M R D, B M A sa m ples will be se nt t o a ce ntral la b orat or y  a n d e val uate d 
b y  ne xt ge nerati o n se q ue nci n g ( N G S) t o i de ntif y a n d q ua ntif y t he rearra n ge d ge netic 
se q ue nces (e g, I g H, I g K, a n d I g L rece pt or ge ne se q ue nces).  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 0
8. 3. S afe t y Assess me nts
Safet y  e n d p oi nts i ncl u de a d verse e ve nts ( gra de d acc or di n g t o t he N CI C T C A E, versi o n 5 . 0), 
cli nical e xa mi nati o n (i ncl u di n g bl o o d press ure a n d p ulse), la b orat or y  tests ( he mat ol o g y, 
c he mistr y, c oa g ulati o n a n d uri nal ysis) a n d E C Gs r u n i n tri plic ate.
A d diti o nal pr oce d ures or sa m ples ma y  be u n derta ke n as me dically re q uire d at t he discreti o n 
of t he I n vesti gat or.  I n a d diti o n t o t he l ocal la b orat or y  tests, a d diti o nal bl o o d sa m ples ma y be 
ta ke n, or a d diti o nal tests ma y be c o n d ucte d i n e xisti n g sa m ples, f or a nalys es at eit her ce ntral 
or l ocal la b orat ories i n or der t o pr o vi de t he best p ossi ble g ui da nce o n i m pr o vi n g t he me dical 
ma na ge me nt of st u d y patie nts o n e mer gi n g safet y fi n di n gs d uri n g t he c o n d uct of t he st u d y.
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A .  U nsc he d ule d cli nical 
la b orat or y meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u dy t o assess a n y 
percei ve d safet y  c o ncer ns.
8. 3. 1. P h ysic al E x a mi n ati o ns
A brief p h ys ical e xa mi nati o n will i ncl u de, at a mi ni m u m, assess me nts of s ki n, 
hea d/e y es/ears/ n ose/t hr oat, heart, l u n gs, testes, a b d o me n, e xtre mities, ne ur ol o gical, 
bac k/s pi nal, li ver, s plee n, a n d l ym p h
n o des; Hei g ht a n d wei g ht will als o be meas ure d a n d 
rec or de d.
I n vesti gat ors s h o ul d pa y s pecial atte nti o n t o cli nical si g ns relate d t o pre vi o us seri o us 
ill nesses. 
P h y sical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d 
will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. A n y u nt o war d p h y sical 
e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d meet t he 
defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he pr ocesses in 
Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 2. Vit al Si g ns
Vital si g ns i ncl u de bl o o d press ure, p ulse a n d te m perat ure.  Perf or me d o n all da y 'stest article
(i n ot uz u ma b oz o ga mici n) is a d mi nistere d f or all c ycles ( pre d ose a n d 1 h o ur [± 1 5 mi n utes] 
after t he e n d of eac h i n ot uz u ma b oz o ga mici n i nf usi o n; als o perf or me d 2 h o urs [± 1 5 mi n utes] 
after t he e n d of i n ot uz u ma b oz o ga mici n i nf usi o n f or C y cle 1 Da y 1 d ose).
A n y  u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Se cti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 3. Electr oc ar di o gr a ms
E C Gs will be c ollecte d i n all patie nts as descri be d i n Ta ble 3 .  T he E C Gs will be c ollecte d i n
tri plicate ( 3 c o nsec uti ve E C Gs a p pr o xi matel y 2 mi n utes a part).   Pre d ose E C Gs will be
perf or me d pri or t o d osi n g, b ut after a d mi nistrati o n of pre me dicati o ns.   E C Gs will be d o ne
i m me diatel y pri or t o t he e n d of i nf usi o n pri or t o P K sa m ple c ollecti o n ( wit hi n 1 5 mi n utes).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 1
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n Secti o n 1 0. 6 A p pe n di x 6 .
8. 3. 4. Cli nic al S afet y L a b or at or y Assess me nts
See Secti o n 1 0. 2 A p pe n di x 2 f or t he list of cli nical safety la b orat or y  tests t o be perf or me d 
a n d t he S o A f or t he ti mi n g a n d fre q ue nc y. All pr ot oc ol re q uire d la b orat or y assess me nts, as 
defi ne d i n A p pe n di x 2 , m ust be c o n d ucte d i n acc or da nce wit h t he la b orat or y ma n ual a n d t he 
S o A .
U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y 
t o assess a ny percei ve d safet y c o ncer ns .
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y si g nifica nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F.  
Cli nicall y  si g nifica nt a b n or mal la b orat or y test fi n di n gs are t h ose w hic h are n ot ass ociate d 
wit h t he u n derl y i n g disease, u nless j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n 
e x pecte d f or t he partici p a nt's c o n diti o n.
All la b orat or y  tests wit h val ues c o nsi dere d cli nicall y si g nifica nt a n d a b n or mal d uri n g 
partici pati o n i n t he st u d y  or wit hi n 9 wee ks after t he last d ose of st u d y i nter ve nti o n, u nless a 
ne w a nti-ca ncer t hera p y is gi ve n, s h o ul d be re peate d u ntil t he val ues ret ur n t o n or mal or 
baseli ne or are n o l o n ger c o nsi dere d cli nicall y  si g nifica nt b y t he i n vesti gat or or st u d y 
me dical m o nit or.
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne wit hi n a peri o d of ti me j u d ge d reas o na ble b y 
t he i n vesti gat or, t he eti ol o g y s h o ul d be i de ntifie d a n d t he s p o ns or n otifie d.
See A p pe n di x 5 f or s u g geste d acti o ns a n d f oll o w- u p assess me nts i n t he e ve nt of p ote ntial 
DI LI. See A p pe n di x 1 2 f or i nstructi o ns f or la b orat or y  testi n g t o m o nit or ki d ne y f u ncti o n a n d 
re p ort la b orat or y test a b n or malities.
N o nee d t o re peat a cli nical la b orat or y  assess me nt o n C y cle 1 Da y 1 if t he baseli ne 
assess me nt was perf or me d wi t hi n 7 2 h o urs pri or to t hat date.
8. 3. 5. He p atic E ve nts A dj u dic ati o n C o m mitee
T he st u d y will als o use a n e xter nal H E A C. T his A dj u dicati o n C o m mitee will re vie w safety 
data wit h res pect t o t he p ote ntial cases of V O D/ S O S a n d H y ’s la w.
8. 3. 6. Pre g n a nc y Testi n g 
A ser u m pre g na nc y  test is re q uire d at scree ni n g. F oll o wi n g scree ni n g, pre g na nc y  tests ma y 
be uri ne or ser u m tests, a n d m ust ha ve a se nsiti vit y  of at least 2 5 mI U/ m L . Pr e g na nc y tests 
will be perf or me d i n w o ma n of c hil d beari n g p ote ntial ( W O C B P) at t he ti mes liste d i n t he 
S o A (Ta ble 1 ).
F oll o wi n g a ne gati ve pre g na nc y  test res ult at scree ni n g, a p pr o priate c o ntrace pti o n m ust be 
c o m me nce d a n d a sec o n d ne gati ve pre g na nc y test res ult will be re q uire d at t he baseli ne visit 
pri or t o t he partici pa nt’s recei vi n g t he st u dy treat me nt.  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 2
Pre g na nc y  tests will als o be d o ne w he ne ver o ne me nstr ual c ycle is misse d d uri n g t he acti ve 
treat me nt peri o d ( or w he n p ote ntial pre g na nc y is ot her wise s us pecte d) a n d at t he e n d of t he 
st u d y.  Pre g na nc y tests ma y als o be re peate d as per re q uest of i nstit uti onal re vie w b oar ds 
(IR B)/ E Cs or if re q uire d b y  l ocal re g ulati o ns. 
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her S afet y Re p orti n g
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n Secti o n 1 0. 3   A p pe n di x 3 .
A Es ma y  arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or , w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt's le gally 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he i n vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g , d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or c a use d t he partici pa nt t o disc o nti n ue 
t he i n ot uz u ma b oz o ga mici n (see Secti o n 7 ). 
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 8. 4. 1 , eac h partici pa nt/le gall y 
a ut h orize d re prese ntati ve will be q uesti o ne d a b o ut t he occ urre nce of A Es i n a n o nlea di n g 
ma n ner .
I n a d diti o n, t he i n vesti gat or ma y be re q ueste d b y Pfizer Safety t o o btai n s pecific f oll o w- u p 
i nf or mati o n i n a n e x pe dite d fas hi o n.
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g A Es a n d S A Es (“acti ve c ollecti o n 
peri o d”) f or eac h partici pa nt be gi ns fr o m t he ti me t he pa rtici pa nt pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d bef ore u n der g oi n g a n y st u d y relate d pr oce d ure a n d/ or recei vi n g st u d y 
i nter ve nti o n, t hr o u g h a n d i ncl u di n g a mi ni m u m of 9 wee ks after t he last a d mi nistrati o n of t he 
st u d y i nter ve nti o n, e xce pt as i n dicate d bel o w, after t he last a d mi nistrati o n of t he st u d y 
i nter ve nti o n. 
F or partici pa nts w h o are scree n fail ures, t he acti ve c ollecti o n peri o d e n ds w he n scree n 
fail ure stat us is deter mi ne d.
T he “acti ve c ollecti o n peri o d” f or V O D/ S O S is t he e ntire d urati o n of st u d y partici pati o n, 
i ncl u di n g t he l o n g ter m f oll o w-u p peri o d, re gar dless of w het her ne w a nti-ca ncer treat me nt is 
i nitiate d.  All cases of V O D/ S O S will be re p orte d i n t he C R F f or u p t o 2 years fr o m C y cle 1 
D a y  1 a n d m ust be re p orte d as S A Es (rec or de d o n t he C R F a n d C T S A E Re p ort F or m).
F oll o w -u p b y  -t he i n vesti gat or c o nti n ues t hr o u g h o ut t he acti ve c ollecti o n peri o d a n d u ntil t he 
A E or S A E or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or .
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 3
W he n a cli nicall y  i m p orta nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y  t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d Pfizer c o nc urs wit h t hat assess me nt.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt f or t he c ollecti o n of 
f ut ure i nf or mati on, t he acti ve c ollecti o n peri o d e n ds w he n c o nse nt is wit h dra w n.
If a partici pa nt per ma ne ntl y disc o nti n ues or te m p orarily disc o nti n ues st u d y i nter ve nti o n 
beca use of a n A E or S A E, t he A E or S A E m ust be rec or de d o n t he C R F a n d t he S A E 
re p orte d usi n g t he C T SA E Re p ort F or m.
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n o n A Es or S A Es after t he 
partici pa nt has c o ncl u de d st u d y  partici pati o n.  H o we ver, if t he i n vesti gat or lear ns of a ny 
S A E, i ncl u di n g a deat h, at a n y  ti me after a partici pa nt has c o mplete d t he st u d y , a n d t he y 
c o nsi der t he e ve nt t o be reas o na bl y relate d t o t he st u d y  i nter ve nti o n, t he i n vesti gat or m ust 
pr o m ptl y  re p ort t he S A E t o Pfizer usi n g t he C T S A E Re p ort F or m.
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n 
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y o n t he C T S A E Re p ort F or m i m me diatel y u p o n 
a ware ness a n d u n der n o circ u msta nc e s ho ul d t his e xcee d 2 4 h o urs, as i n dicate d i n  
A p pe n di x 3 .  T he i n vesti gat or will s u b mit a n y u p date d S A E data t o t he s p o ns or wit hi n 
2 4 h o urs of it bei n g a vaila ble.
If a partici pa nt be gi ns a ne w a ntica ncer t hera py, S A Es occ urri n g d uri n g t he a b o ve i n dicate d 
acti ve c ollecti o n peri o d m ust still be re p orte d t o Pfizer Safet y  irres pecti ve of a n y i nter ve ni n g 
treat me nt. N ote t hat a s witc h t o a c o m mercially a vaila ble versi o n of t he st u d y i nter ve nti o n is 
c o nsi dere d as a ne w a ntica ncer t hera p y f or p ur p oses of S A E re p orti n g.
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F. 
T he i n vesti gat or is t o rec or d o n t he C R F all directl y  o bser ve d, a n d all s p o nta ne o usl y re p orte d 
A Es a n d S A Es re p orte d b y  t he partici pa nt.
As part of o n g oi n g safet y re vie ws c o n d ucte d b y  t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y t he s p o ns or as a n S A E. T o assist 
i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y an d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
If a partici pa nt be gi ns a ne w a ntica ncer t hera py, t he rec or di n g peri o d f or n o nseri o us A Es 
e n ds at t he ti me t he ne w treat me nt is starte d; h o we ver, S A Es m ust c o nti n ue t o be rec or de d o n 
t he CR F d uri n g t h e a b o ve i n dicate d acti ve c ollecti o n peri o d. N ote t hat a s witc h t o a 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 4
c o m merciall y a vaila ble versi o n of t he st u d y i nter ve nti o n is c o nsi dere d as a ne w a ntica ncer 
t hera py f or t he p ur p oses of S A E re p orti n g.
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es
T he met h o d of rec or di n g, e val uati n g, a n d assessi n g ca usalit y  of A Es a n d S A Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n Secti o n 1 0. 3   
A p pe n di x 3 .
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A Es a n d/ or S A Es.  O pe n -e n de d a n d 
n o nlea di n g ver bal q uesti o ni n g of t he partici pa nt is t he preferre d met h o d t o i n q uire a b o ut 
A E occ urre nces.
8. 4. 3. F oll o w - u p of A Es a n d S A Es
After t he i nitial A E/ S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts.  F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u nti l res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa nt is l ost t o f oll o w- u p (as defi ne d i n Secti o n 7. 3 ).
In ge neral, f oll o w - u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y .  A ny i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o m ita nt me dicati o ns 
a n d ill nesses, m ust be pr o vi de d.  I n t he case of a partici pa nt deat h, a s u m mar y of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y. 
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is gi ve n i n Secti o n 1 0. 3   A p pe n di x 3 .
8. 4. 4. Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificati o n b y  t he i n vesti gat or t o t he s p o ns or of a n S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war ds t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met.
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n.  T he 
s p o ns or will c o m pl y wit h c o u ntr y s pecific re g ulat or y re q uire me nts relati n g t o safety 
re p orti n g t o t he re g ulat or y a ut h ority, i nstit uti o nal re vie w b oar ds (I R Bs)/et hics c o m mittees 
( E Cs), a n d i n vesti gat ors.
I n vesti gat or safet y re p orts m ust be pre pare d f or s us pecte d u ne x pecte d seri o us a d verse 
reacti o ns ( S U S A Rs) acc or di n g t o l ocal re g ulat or y re q uire me nts a n d s p o ns or p olic y a n d 
f or war de d t o i n vesti gat ors as necessar y.
A n i n vesti gat o r w h o recei ves S U S A R s or other s pecific safet y i nf or mati o n (e g, s u m mar y or 
listi n g of S A Es) fr o m t he s p o ns or will re vie w a n d t he n file it al o n g wit h t he S R S D(s) f or t he 
st u d y a n d will n otif y t he I R B/ E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 5
8. 4. 5. E n vir o n me nt al E x p os ure, E x p os ure D uri n g Pre g n a nc y or Bre astfee di n g, a n d 
Occ u p ati o n al E x p os ure
E n vir o n me ntal e x p os ure, occ urs w he n a pers o n n ot e nr olle d i n t he st u d y  as a partici pa nt 
recei ves u n pla n ne d direct c o ntact wit h or e x p os ure t o t he st u d y i nter ve nti o n. S uc h e x p os ure 
ma y  or ma y n ot lea d t o t he occ urre nce of a n A E or S A E. Pers o ns at ris k f or e n vir o n me ntal 
e x p os ure i ncl u de healt hcare pr o vi ders, fa mil y me m bers, a n d ot hers w h o ma y be e x p ose d. 
E n vir o n me ntal e x p os ure ma y i ncl u de E D P, E D B, a n d occ u pati o nal e x p os ure.
A n y  s uc h e x p os ure t o t he st u d y i nter ve nti o n u n der st u d y are re p orta ble t o Pfizer Safety 
wit hi n 2 4 h o urs of i n vesti gat or a ware ness.
8. 4. 5. 1. E x p os ure D uri n g Pre g n a nc y
A n E D P  occ urs if:

A fe male partici pa nt is f o u n d t o be pre g na nt w hile recei vi n g or after disc o nti n ui n g 
st u d y i nter ve nti o n. 

A male partici pa nt w h o is recei vi n g or has disc o nti n ue d st u d y  i nter ve nti o n 
i nse mi nates a fe male part ner.

A fe male n o n partici pa nt is f o u n d t o be pre g na nt w hile bei n g e x p ose d or h a vi n g bee n 
e x p ose d t o st u d y i nter ve nti o n beca use of e n vir o n me ntal e x p os ure. Bel o w are 
e xa m ples of e n vir o n me ntal E D P:  

A fe male fa mil y  me m ber or healt hcare pr o vi der re p orts t hat s he is pre g na nt after 
ha vi n g bee n e x p ose d t o t he st u d y  i nter ve nti o n b y s ki n c ontact.

A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y 
i nter ve nti o n b y s ki n c o ntact t he n i nse mi nates his fe male part ner pri or t o or ar o u n d 
t he ti me of c o nce pti o n.
T he i n vesti gat or m ust re p ort E D P  t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o 
ter mi nati o n of pre g na nc y). 

If E D P occ urs i n a partici pa nt/ partici pa nt’s part ner, t he i n vesti gat or m ust re p ort t his 
i nf or mati o n t o Pfizer Safet y  o n t he C T S A E Re p ort F or m a n d a n E D P S u p ple me ntal 
F or m, re gar dless of w het her a n S A E has occ urre d. Details of t he pre g na nc y will be 
c ollecte d after t he start of st u d y i nter ve nti o n a n d u ntil at least 8 m o nt hs after t he last 
d ose. 

If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust re p ort 
i nf or mati o n t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m a n d E D P S u p ple me ntal 
F or m. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 6
t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o p y of t he 
c o m plete d C T S A E Re p ort F or m is mai ntai ne d i n t he i n ve sti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y  a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y  u ntil 
c o m pleti o n ( or u ntil pre g na nc y  ter mi nati o n) a n d n otif y Pfizer Safety of t he o utc o me as a 
f oll o w- u p t o t he i nitial E D P S u p ple me ntal F or m. I n t he case of a li ve birt h, t he str uct ural 
i nte grity of t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a ter mi nati o n, t he 
reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre pr oce d ure test fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
A b n or mal pre g na nc y  o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y i n a li ve-b or n ba b y, a ter mi nate d fet us, a n 
i ntra uteri ne fetal de mise, or a ne o natal deat h), t he i n vesti gat or s h o ul d f oll o w t he pr oce d ures 
f or re p orti n g S A Es. A d diti o nal i nf or mati o n a b o ut pre g na nc y  o utc o mes t hat are re p orte d t o 
Pfizer Safet y  as S A Es f oll o ws: 

S p o nta ne o us a b orti o n i ncl u di n g miscarria ge a n d misse d a b orti o n s h o ul d be re p orte d 
as a n S A E;

Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d 
t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d be re p orte d as 
S A Es w he n t he i n vesti gat or assess es t he i nfa nt deat h as relate d or p ossi bl y  relate d t o 
e x p os ure t o t he st u d y i nter ve nti o n. 
A d diti o nal i nf or mati o n re gar di n g t he E D P ma y  be re q ueste d b y t he s p o ns or. F urt her f oll o w-
u p of birt h o utc o mes will be ha n dle d o n a case -b y -case basis (e g, f oll o w- u p o n preter m 
i nfa nts t o i de ntif y de vel o p me ntal dela ys). I n t he case of pater nal e x p os ure, t he i n vesti gat or 
will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n F or m t o deli ver 
t o his part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat t he partici pa nt 
was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his part ner.
8. 4. 5. 2. E x p os ure D uri n g Bre astfee di n g
A n E D B occ urs if:

A fe male partici pa nt is f o u n d t o be breastfee di n g w hile recei vi n g or after 
disc o nti n ui n g st u d y  i nter ve nti o n.

A fe male n o n partici pa nt is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y  i nter ve nti o n (ie, e n vir o n me ntal e x p os ure). A n e xa m ple of 
e n vir o n me ntal E D B is a fe male fa mil y me m ber or healt hcare pr o vi der w h o r e p orts 
t hat s he is breastfee di n g after ha vi n g bee n e x p ose d t o t he st u d y i nter ve nti o n b y s ki n 
c o ntact.  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 7
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or ’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf o r mati o n m ust be re p orte d 
usi n g t he C T  S A E Re p ort F or m. W he n E D B occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, 
t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he st u d y, s o t he 
i nf or mati o n is n ot rec or de d o n a C R F. H o we ver, a c o py of t he c o m plete d C T  S A E Re p ort 
F or m is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecificall y a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or da nce wit h a ut h orize d use. 
H o we ver , if t he i nfa nt e x perie nces a n S A E ass ociate d wit h s uc h a dr u g, t he S A E is re p orte d 
t o get her wit h t he E D B.
8. 4. 5. 3. Occ u p ati o n al E x p os ure
T he i n vesti gat or m ust re p ort a n y  i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 2 4 
h o urs of t he i n vesti gat or ’s a ware ness usi n g t he C T S A E Re p ort F or m, re gar dless of w het her 
t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure d oes n ot 
pertai n t o a partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; 
h o we ver , a c o p y of t he c o m plete d C T  S A E Re p ort F or m m ust be mai ntai ne d i n t he 
i n vesti gat or site file.
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
N ot a p plica ble.
8. 4. 7. Dise ase Rel ate d E ve nts a n d/ or Dise ase Rel ate d O utc o mes N ot Q u alif yi n g as S A Es
T he f oll o wi n g disease relate d e ve nts ( DR Es) are c o m m o n i n partici pa nts wit h A L L
i n de pe n de nt of e x p os ure t o st u d y i nter ve nti o n, ca n be seri o us/life t hreate ni n g:
Fe brile ne utr o pe nia;
Ne utr o pe nic se psis ;
D isease pr o gressi o n.
T he f oll o wi n g occ urri n g p ost H S C T a n d after disc o nti n uati o n of i n ot uz u ma b
oz o ga mici n:

Ac ute G v H D;

I nfecti o n re q uiri n g I V a nti bi otics; 

He m orr ha ge/ blee di n g; 

Wei g ht l oss/a n ore xia;

Ac ute ki d ne y  i nj ur y;
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 8

Na usea/ v o miti n g/ diarr hea;

T hr o m b oc y t o pe nia/a ne mia. 
Beca use t hese e ve nts are t y picall y ass ociate d wit h t he disease u n der st u d y, t he y will n ot be 
re p orte d acc or di n g t o t he sta n dar d pr ocess f or e x pe dite d re p orti n g of S A Es e ve n t h o u g h t he 
e ve nt ma y meet t he defi niti o n of a n S A E, u nless t he I n vesti gat or belie ves t hat t here is a 
ca usal relati o ns hi p bet wee n t he i n vesti gati o nal pr o d uct.  T hese e ve nts will be rec or de d o n t he
c orres p o n di n g C R F pa ge i n t he partici pa nt’s C R F wit hi n t he a p pr o priate ti me fra me. 
N O T E: H o we ver, if eit her of t he f oll o wi n g c o n diti o ns a p plies, t he n t he e ve nt m ust be 
rec or de d a n d re p orte d as a n S A E (i nstea d of a D R E):
T he e ve nt is, i n t he i n vesti gat or’s o pi ni o n, of greater i nte nsit y , fre q ue nc y, or d urati o n 
t ha n e x pecte d f or t he i n di vi d ual partici pa nt.
O R
T he i n vesti gat or c o nsi ders t hat t here is a reas o na ble p ossi bilit y  t hat t he e ve nt was 
relate d t o st u dy i nter ve nti o n.
Gra de 5 ( or wit h a n o utc o me of fatal).
8. 4. 8. A d verse E ve nts of S peci al I nterest
A E SI  c o nstit ute A Es (seri o us or n o n -seri o us) of scie ntific a n d me dical c o ncer n i n t he
e val uati o n of i n ot uz u ma b oz o ga mici n, f or w hic h i n a d diti o n t o o n g oi n g m o nit ori n g, ra pi d 
c o m m u ni cati o n b y t he I nvesti gat or t o t he S p o ns or is c o nsi dere d a p pr o priate. S uc h e ve nts 
ma y  re q uire f urt her i n vesti gati o n i n or der t o c haracterize a n d u n dersta n d t he m. A E SI ma y  be 
a d de d or re m o ve d d uri n g a st u d y  b y Pr ot oc ol A me n d me nt.
Re p orti n g of A E SI Wi t h I m me di ate N otific ati o n
I n vesti gat or s h o ul d n otif y t he s p o ns or i m me diatel y (ie, wit hi n 2 4 h o urs) of t he f oll o wi n g
e ve nts, as per S A E n otificati o n a n d/ or usi n g t he pre g na nc y  f or m ( w hic he ver is a p plica ble):

H y ’s La w cases (see Secti o n 1 0. 5 )

P ote ntial V O D/ S O S Cases (see Secti o n 8. 4. 8. 2 )

A ll s us pecte d cases of he patic S O S, irres pecti ve of ti mi n g, ca usalit y a n d se verit y, 
s h o ul d be re p orte d i n t he A E C R F . If t he e ve nt is dee me d seri o us b y t he i n vesti gat or, 
t he S A E re p orts s h o ul d i ncl u de a c o m plete list of all a ntica ncer t hera py a d mi nistere d 
bef ore, d uri n g a n d after st u d y  t hera p y, i ncl u di n g pre- a n d p ost-st u d y H S C T 
c o n diti o ni n g, G V H D pr o p h y la xis a n d treat me nt, a n d all c o nc o mita nt me dicati o ns 
use d f or pre ve nti o n of he patic t o xici t y (e g, urs o di ol, defi br oti de, l o w m olec ular 
wei g ht he pari n) a n d/ or f or t he treat me nt of S O S (ie, defi br oti de).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 6 9

E x p os ure d uri n g Pre g na nc y  (see Secti o n 8. 4. 5. 1 )

Sec o n d pri mar y  mali g na nc y
Re p orti n g of A E SI W it h o ut Im me diate N otificati o n ( u nless assesse d as S A E [see
Secti o n 8. 4. 1. 1 f or re p orti n g ti mefra me])

Ne ur ot o xicit y

Ne p hr ot o xicit y

Q T a b n or malities ( defi ne d as Gra de 3, 4, pr ol o n gati o n or Q Tc F p ost - baseli ne a bs ol ute 
val ue of > 5 0 0 msec)

I nterstitial l u n g disease

Pa ncreatitis

M y el os u p pressi o n/c yt o pe nia i ncl u di n g I nfecti o ns a n d He m orr ha ges
A E SI s are e xa mi ne d as part of r o uti ne safet y data re vie w pr oce d ures t hr o u g h o ut t he cli nical 
trial a n d as part of si g nal detecti o n pr ocesses. S h o ul d a n a g gre gate a nal y sis i n dicate t hat 
t hese pres pecifie d e ve nts occ ur m ore fre q ue ntly t ha n e x pecte d, e g, base d o n e pi de mi ol o gical 
data, literat ure, or ot her data, t he n t his will be s u b mitte d a n d re p orte d i n acc or da nce wit h 
Pfizer’s safet y re p orti n g re q uire me nts. A g gre gate a nal ys es of safet y data will be perf or me d 
o n a re g ular basis per i nter nal S O Ps.
All A E SI s m ust be re p orte d as a n A E or S A E f oll o wi n g t he pr oce d ures descri be d i n 
Secti o ns 8. 4. 1 t hr o u g h 8. 4. 4 .A n A E SI  is t o be rec or de d as a n A E or S A E o n t he C R F . I n 
a d diti o n, a n A E SI t hat is als o a n S A E m ust be re p orte d usi n g t he C T S A E Re p ort F or m.
8. 4. 8. 1. L ac k of Effic ac y
T he i n vesti gat or m ust re p ort si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
efficac y.  Lac k of efficac y or fail ure of e x pecte d p har mac ol o gical acti o n is re p orta ble t o Pfizer 
Safet y  o nl y if ass oci ate d wit h a n S A E .  
8. 4. 8. 2. P ote nti al V O D/ S O S C ases 
All cases of V O D, als o k n o w n as S O S, re gar dless o f ca usality, se verit y a n d treat me nt ar m 
m ust als o be re p orte d as a n S A E f or t he e ntire d urati o n of st u d y  partici pati o n u p t o 2 y ears 
after t he first d ose of i n ot uz u ma b oz o ga mici n, i ncl u di n g t he F oll o w- u p peri o d ( Ta ble 1 ).  
E ve nts of V O D w hic h occ ur t hereafter s h o ul d be re p orte d f oll o wi n g t he S A E re p orti n g 
criteria.  I n t he e ve nt of seri o us or se vere he patic a d verse e ve nts, patie nts s h o ul d ha ve a 
he pat ol o g y  c o ns ultati o n a n d w or k u p i ncl u di n g ( b ut n ot li mite d t o), wei g hts, i nfecti o us 
he patitis testi n g ( A, B, C).  W he n e val uati n g li ver t o xicit y , i nf or m t he ra di ol o gist of t he 
p ote ntial f or he patic vasc ular disease.  W he n V O D is i n t he differe ntial dia g n osis, a ri g ht 
u p per q ua dra nt ultras o u n d wit h c ol or fl o w d o p pler (i ncl u di n g resisti ve i n dices t o he patic 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 0
arter y fl o w a n d e val uati o n of he patic ve n o us o utfl o w) s h o ul d be perf or me d.  In a d diti o n, t he 
ra di ol o g y re p ort s h o ul d descri be c o m m o n bile d uct, t he de gree of gall bla d der wall 
t hic ke ni n g i n milli meters, a n d t he v ol u me of ascites s h o ul d be esti mate d as cl osel y as 
p ossi ble (ie, s mall a n d l ocalize d, m o derate a n d ge neralize d, or lar ge a n d ge neralize d).  
Assess me nt of a b d o mi nal t u m or(s); c ollecti o n of alc o h ol use i nf or mati o n ( hist orical, 
c urre nt); pri or he patitis or a relate d c o n diti o n (eit her i nfecti o us or n o ni nfecti o us , i ncl u di n g 
n o nalc o h olic steat o he patitis [ N A S H, als o k n o w n as n o nalc o h olic fatty li ver or N A F L] a n d 
alc o h olic steat o he patitis [ A S H]), la b orat or y  tests (i ncl u di n g, b ut n ot li mite d t o, c o n ve nti o nal 
li ver f u ncti o n tests, I N R/ pr ot hr o m bi n ti me ( P T), al b u mi n, a n d a m m o nia le vels), a n d 
i nf or mati o n fr o m li ver bi o ps y or a ut o ps y if perf or me d. 
Res ults of all assess me nts, si g ns a n d s y m pt o ms s h o ul d be rec or de d i n t he C R F (i ncl u di n g 
i ma gi n g res ults, bi o psy res ults, vital si g ns [i ncl u di n g c ha n ges i n wei g ht], detaile d perti ne nt 
p h y sical e xa m, la b orat or y val ues, n o nst u d y me dicati o ns [i ncl u di n g her bal s u p ple me nts a n d 
her bal teas, if a p plica ble], sites of disease ot her a d verse e ve nts partic ularl y  rece nt a n d/ or 
c o nc urre nt i nfecti o ns, a n d o t her n o nst u d y treat me nts); u n pla n ne d C R F pa ges ca n be use d if 
necessar y .  Assess me nt (rec or di n g) of wei g hts i n a patie nt e x perie nci n g a n y  he patic e ve nt is 
i m p orta nt beca use it ca n hel p i n t he differe ntial dia g n osis, gi ve n t he ass ociati o n of fl ui d 
rete nti o n wit h p ortal h y p erte nsi o n a n d V O D.  O ne of t he maj or disti ncti o ns bet wee n m ost 
ac ute li ver dis or ders i n o nc ol o g y patie nts a n d V O D is t he prese nce of p ortal h y perte nsi o n, 
w hic h lea ds t o re nal rete nti o n of salt a n d water, a n d t h us, t o a br u pt gai ns i n wei g ht .
F or t his st u d y , criteria f or V O D (als o k n o w n as S O S) are defi ne d as :2 0
a.
Classical V O D (first 2 1 da y s after H S C T): 

Bilir u bi n 2 m g/ d L a n d t w o ( or m o re) of t he f oll o wi n g criteria m ust als o be 
prese nt;

Pai nf ul he pat o me gal y;

Wei g ht gai n > 5 %;

Ascites.
b.
Late o nset V O D ( > 2 1 d a y s after H S C T):

Classical V O D be y o n d Da y 2 1;
or

Hist ol o gicall y pr o ve n V O D;
or

T w o or m ore of t he f oll o wi n g criteria m ust be prese nt:
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 1

Bilir u bi n > 2 m g/ Dl;

Pai nf ul he pat o me gal y;

Wei g ht gai n > 5 %;

Ascites.
A N D he m o d y na mical a n d/ or ultras o u n d e vi de nce of V O D.
F or t his st u d y, se verity of V O D is defi ne d as f oll o ws ( Ta ble 9 ).
T a ble 9 .
V O D Se verit y Gr a di n g ( P atie nts Bel o n g t o t he C ate g or y t h at F ulfills 
T w o or M ore Criteri a) a
Mil d
( Gra de 1)b
M o der ate
( Gra de 2)b
Se vere
( Gra de 3)
Ver y se vere
( Gra de 4)c
Ti m e si nce first 
cli nical s y m pt o ms d
> 7 da ys
5- 7 da ys
4 da ys
A n y ti me
Bilir u bi n ( m g/ d L)
2 a n d < 3
3 a n d < 5
5 a n d < 8
8
Bilir u bi n ( u m ol/ L)
3 4 a n d < 5 1
5 1 a n d < 8 5
8 5 a n d < 1 3 6
1 3 6
Bilir u bi n ki netics
d o u bli n g 4 8 hr
Tra nsa mi nases
2 × U L N
> 2 a n d 5 × U L N
> 5 a n d 8 × U L N
> 8 × U L N
Wei g ht i ncrease
< 5 %
5 % a n d < 1 0 %
5 % a n d < 1 0 %
> 1 0 %
Re nal F u ncti o n
< 1. 2 × baseli ne 
at H S C T
1. 2 a n d 
< 1. 5 × baseli ne at 
H S C T
1. 2 a n d 
< 1. 5 × baseli ne at 
H S C T
2 × baseli ne at 
H S C T or ot her 
si g ns of 
M O D/ M O F
A b bre viati o ns: hr = h o ur; H S C T = he mat o p oietic ste m cell tra ns pla nt; M O D = m ulti -or ga n d ysf u ncti o n;
M O F = m ulti -or ga n fail ure; U L N = u p per li mit of n or mal.
a.
If patie nts f ulfill t w o or m ore criteria i n t wo differe nt cate g ories, t he y m ust be classifie d i n t he m ost 
se vere cate g or y.  Patie nts wei g ht i ncrease 5 % a n d < 1 0 % is c o nsi dere d b y defa ult as a criteri o n f or se vere 
V O D; h o we ver, if patie nts d o n ot f ulfill ot her criteria f or se vere V O D, w ei g ht i ncrease 5 % a n d < 1 0 % is 
t heref ore c o nsi dere d as a criteri o n f or m o derate V O D.
b.
I n t he case of prese nce of t w o or m ore ris k fact ors f or V O D, patie nts s h o ul d be i n t he u p per gra de.
c.
Patie nts wit h m ulti -or ga n d ysf u ncti o n m ust be classifie d as ver y se vere.
d.
Ti m e fr o m t he date w he n t he first si g ns/s y m pt o ms of V O D be ga n t o a p pear (retr os pecti vel y 
deter mi ne d).a n d t he date w he n t he s y m pt o ms f ulfille d V O D dia g n ostic criteria.
See als o Secti o n 1 0. 1 0   A p pe n di x 1 0 f or g ui da nce a b o ut rec o m me n dati o n f or patie nts 
pr ocee di n g t o H S C T a n d p ote ntial V O D cases.
8. 4. 9.
Me dic al De vice Deficie ncies
N ot a p plica ble.
8. 4. 1 0. Me dic ati o n Err ors
Me dicati o n err ors ma y  res ult fr o m t he a d mi nistrati o n or c o ns u m pti o n of t he st u d y 
i nter ve nti o n b y t he wr o n g partici pa nt, or at t he wr o n g ti me, or at t he wr o n g d osa ge stre n gt h.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 2
Me dicati o n err ors are rec or de d a n d re p orte d as f oll o ws:
Rec or de d o n t he 
M e dic ati o n Err or 
P a ge of t he C R F
Rec or de d o n t he A d verse 
E ve nt P a ge of t he C R F
Re p orte d o n t he C T S A E 
Re p ort F or m t o Pfizer S afet y 
Wit hi n 2 4 H o urs of A w are ness
All (re gar dless of 
w het her ass ociate d 
wit h a n A E)
A n y  A E or S A E ass ociate d 
wit h t he me dicati o n err or
O nl y  if ass ociate d wit h a n S A E
Me dicati o n err ors i ncl u de:
Me dicati o n err ors i n v ol vi n g partici pa nt e x p os ure t o t he st u d y  i ntere v nti o n;
P ote ntial me dicati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o 
or d o n ot i n v ol ve t he st u d y partici pa nt.
S uc h me dicati o n err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d o n t he me dicati o n 
err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge.
W het her or n ot t he me dicati o n err or is acc o m pa nie d b y  a n A E, as deter mi ne d b y t he 
i n vesti gat or, t he me dicati o n err or is rec or de d o n t he me dicati o n err or pa ge of t he C R F a n d, if 
a p plica ble, a n y ass ociate d A E(s), seri o us a n d n o nseri o us, are rec or de d o n a n A E pa ge of t he 
C R F.
I n t he e ve nt of a me dicati o n d osi n g err or, t he s p o ns or s h o ul d be n otifie d wit hi n 2 4 h o urs.
Me dicati o n err ors s h o ul d be re p orte d t o Pfizer Safet y wit hi n 2 4 h o urs o n a C T S A E Re p ort 
F or m o nl y w he n ass oci ate d wit h a n S A E .
8. 5. P h ar m ac o ki netics 
Bl o o d sa m ples of a p pr o xi matel y  4 m L , t o pr o vi de a mi ni m u m of 1. 3 5 m L of ser u m, will be 
c ollecte d f or meas ure me nt of ser u m c o nce ntrati o ns of i n ot uz u ma b oz o ga mici n a n d free
calic hea mici n as s pecifie d i n t he S o A (Ta ble 1 ).  I nstructi o ns f or t he c ollecti o n a n d ha n dli n g 
of bi ol o gical sa m ples will be pr o vi de d i n t he la b orat or y  ma n ual or b y t he s p o ns or.  T he 
act ual date a n d ti me ( 2 4-h o ur cl oc k ti me) of eac h sa m ple will be rec or de d.
T he act ual ti mes ma y  c ha n ge, b ut t he n u m ber of sa m ples will re mai n t he sa me.  All eff orts 
will be ma de t o o btai n t he sa m ples at t he e xact n o mi nal ti me relati ve t o d osi n g.  C ollecti o n of
sa m ples u p t o a n d i ncl u di n g 1 0 h o urs after d ose a d mi nistrati o n t hat are o btai ne d wit hi n 
1 0 % of t he n o mi nal ti me (e g, wit hi n 6 mi n utes of a 6 0- mi n ute sa m ple) relati ve t o d osi n g will 
n ot be ca pt ure d as a pr ot oc ol de viati o n, as l o n g as t he e xact ti me of t he c ollecti o n is n ote d o n 
t he s o urce d oc u me nt a n d data c ollecti o n t o ol (e g, C R F).
C ollecti o n of sa m ples m ore t ha n 
1 0 h o u rs after d ose a d mi nistrati o n t hat are o btai ne d ≤1 h o ur a wa y fr o m t he n o mi nal ti me 
relati ve t o d osi n g will n ot be ca pt ure d as a pr ot oc ol de viati o n, as l o n g as t he e xact ti me of t he 
c ollecti o n is n ote d o n t he s o urce d oc u me nt a n d data c ollecti o n t o ol (e g, C R F ). 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 3
Sa m ples will be use d t o e val uate t he P K of i n ot uz u ma b oz o ga mici n a n d free calic hea mici n.  
Eac h ser u m sa m ple will be di vi de d i nt o t hree ali q u ots ( 1 f or i n ot uz u ma b oz o ga mici n a n d 2 
f or free calic hea mici n).  Sa m ples c ollecte d f or a nal yses of i n ot uz u ma b ozo ga mici n a n d free
calic hea mici n c o nce ntrati o n ma y  als o be use d t o e val uate safety or efficac y as pects relate d t o 
c o ncer ns arisi n g d uri n g or after t he st u d y , f or meta b olite i de ntificati o n a n d/ or e val uati o n of 
t he bi oa nalyt ical met h o d, or f or ot her i nter nal e x pl orat or y p ur p oses.
Ge netic a nal ys es will n ot be perf or me d o n t hese ser u m sa m ples.  Partici pa nt c o nfi de ntialit y 
will be mai ntai ne d.
Sa m ples c ollecte d f or meas ure me nt of ser u m c o nce ntrati o ns of i n ot uz u ma b oz o ga mici n a n d
free calic hea mici n will be a nal yz e d usi n g a vali date d a nal yt ical met h o d i n c o m plia nce wit h 
a p plica ble sta n dar d o perati n g pr oce d ures ( S O Ps).
T he P K sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns pr o vi de d t o 
t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y. A n y  de viati o ns fr o m t he P K sa m ple 
ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, i nteri m st ora ge or s hi p pi n g 
c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d a n d re p orte d t o t he s p o ns or.  
O n a case b y case basis, t he s p o ns or ma y ma ke a deter mi nati o n as t o w het her sa m ple 
i nte grity has bee n c o m pr o mise d.
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
Ge netics (s pecifie d a nal yses) are n ot e val uate d i n t his st u d y .
8. 7. Bi o m ar kers
U nless pr o hi bite d b y  l ocal re g ulati o ns ( H G R A C, etc.) or et hics c o m mittee decisi o n(s), t he 
f oll o wi n g sa m ples will be c ollecte d fr o m all partici pa nts i n t his st u d y as s pecifie d i n t he S o A .
B o ne marr o w as pirate ( B M A) f or mi ni mal resi d ual disease ( M R D): B M A sa m pli n g will be 
c ollecte d at ti me p oi nts s pecifie d i n t he S o A . M R D will be e val uate d usi n g ne xt ge nerati o n 
se q ue nci n g ( N G S) t o i de ntif y a n d q ua ntif y t he rearra n ge d ge netic se q ue nces (e g, I g H, I g K, 
a n d I g L rece pt or ge ne se q ue nces) at a ce ntral la b orat or y. T his u ni q ue i m m u n o gl o b uli n 
rece pt or re pert oire defi nes t he patie nt-s pecific mali g na nt B l ym p h oc y t e cl o ne a n d is use d as a 
baseli ne refere nce f or c o m paris o n t o s u bse q ue nt sa m ples. O n -treat me nt B M A sa m ples are
use d t o m o nit or f or t he i de ntifie d cl o nes. M R D a nal y sis will be d o ne at least o nce i n patie nts 
wit h pri or assess me nt of C R or C Ri. 
C D 2 2 i m m u n o p he n ot ypi n g perf or me d at scree ni n g o n peri p heral bl o o d or b o ne marr o w
as pirate.  S urface C D 2 2 e x pressi o n s h o ul d be meas ure d b y  fl u oresce nce-acti vate d cell s orter
(F A C S); i m m u n o hist oc he mistr y (IH C) a nal y sis is all o we d i n patie nts wit h 1) dr y ta p or 2) if 
B M as pirate was i na de q uate a n d/ or wit h i ns ufficie nt ci rc ulati n g blasts f or F A C S. 
FI S H: B o ne marr o w as pirates m a y als o be a nal yz e d b y fl u oresce nce i n sit u h ybri dizati o n 
a nal ys is ( FI S H) f or detecti o n of c hr o m os o mal a berrati o ns at scree ni n g.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 4
Kar y ot y pi n g will be perf or me d i n all patie nts, at scree ni n g a n d at lea st o nce i n patie nts 
ac hie vi n g C R or C Ri w h o ha d a b n or mal c y t o ge netics at baseli ne.  It is rec o m me n de d t hat 
2 0 or m ore meta p hases be c o u nte d f or c y t o ge netics a nal ysis.
8. 8. I m m u n o ge nicit y Assess me nts
8. 8. 1. A n al ysis of A nti -I n ot uz u m a b Oz o g a mici n A nti b o dies a n d Ne utr alizi n g 
A nti -I n ot uz u m a b Oz o g a mici n A nti b o dies
Bl o o d sa m ples will be c ollecte d f or deter mi nati o n of A D A a n d N A b a gai nst i n ot uz u ma b
oz o ga mici n as s pecifie d i n t he S o A .  Instr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bi ol o gical
sa m ples will be pr o vi de d i n t he la b orat or y ma n ual or b y t he s p o ns or.  T he act ual date a n d 
ti me ( 2 4- h o ur cl oc k ti me) of eac h sa m ple c ollecti o n will be rec or de d o n t he C R F.
Sa m ples c ollecte d f or deter mi nati o n of A D A a n d N A b ma y  als o be use d f or a d diti o nal 
characterizati o n of t he i m m u ne res p o nse a n d/ or e val uati o n of t he bi oa nal ytical met h o d, or f or 
ot her i nter nal e x pl orat or y p ur p oses . Unless pr o hi bite d b y  l ocal re g ulati o ns or et hics 
c o m mittee decisi o n, these data will be use d f or i nter nal e x pl orat or y  p ur p oses.
Ge netic a nal ys es will n ot be perf or me d o n t hese ser u m sa m ples.  Partici pa nt c o nfi de ntialit y  
will be mai ntai ne d.
Sa m ples will be a nal y ze d usi n g a vali date d a nal yt ical met h o d i n c o m plia nce wit h a p plica ble 
S O Ps. Sa m ples deter mi ne d t o be p ositi ve f or A D A ma y be f urt her c haracterize d f or N A b.
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y . A n y de viati o ns fr o m t he 
i m m u n o ge nicity sa m ple ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, 
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d 
a n d re p orte d t o t he s p o ns or. O n a case -b y -case basis, t he s p o ns or ma y  ma ke a deter mi nati o n 
as t o w het her sa m ple i nte grit y has bee n c o m pr o mise d.
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/ me dical res o urce utilizati o n a n d healt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
Detaile d met h o d ol o g y  f or s u m mar y a n d statistical a nalys es of t he data c ollect e d i n t his st u d y 
is o utli ne d here a n d f urt her detaile d i n S A P, w hic h will be mai ntai ne d b y t he s p o ns or.  T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nal ys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
9. 1. Esti m a n ds a n d St atistic al H y p ot heses
T he pri mar y  o bjecti ve of t his st u d y is t o e val uate t he treat me nt effect wit h i n ot uz u ma b 
oz o ga mici n, b y de m o nstrati n g a greater C R/ C Ri rate t ha n t hat o bser ve d wit h h ist orical 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 5
c o ntr ol.  T he statistical h y p ot heses f or t he pri mar y e n d p oi nt C R/ C Ri per i n vesti gat or’s 
assess me nt are t he sa me as t h ose use d i n gl o bal pi v otal P hase 3 St u d y  B 1 9 3 1 0 2 2, w here 
base d o n re vie w of t he literat ure p u blis he d hist orical data, t he e x pecte d C R/ C Ri rate wit h 
hist orical c o ntr ol i n t he c o m bi ne d first a n d sec o n d sal va ge setti n g was a p pr o xi matel y  3 7 %.  
T he o bser ve d res ults i n t he c o ntr ol ar m i n St u d y  B 1 9 3 1 0 2 2 di d n’t e xcee d 37 % eit her. T he 
st u d y will test t he n ull h y p ot hesis H 0: C R/ C Ri rate per i n vesti gat or’s assess me nt ≤3 7 % vs 
t he alter nati ve hy p ot hesis Ha: C R/ C Ri rate ≥6 1 % w here b ot h h y p ot heses are c o nsiste nt wit h 
t h ose fr o m st u d y B 1 9 3 1 0 2 2.
9. 1. 1. Pri m ar y Esti m a n ds
T he pri mar y  esti ma n d is t he treat me nt effect of i n ot uz u ma b oz o ga mici n fr o m t he ti me of first 
d ose u ntil e n d of treat me nt re gar dless of t olera bilit y , d urati o n o n treat me nt.  T he esti ma n d s
i ncl u des t he f oll o wi n g 4 attri b utes:
P o p ulati o n: Patie nts w h o meet t h e criteria f or As -treate d (Secti o n 9. 3 ).
Varia ble: t he i nci de nce of a patie nt wit h a best o verall res p o nse of C R or C Ri fr o m 
date of t he first d ose t o t he e n d of treat me nt per I nvesti gat or’s assess me nt 
acc or di n g t o a m o difie d C hes o n Criteria ( See Secti o n 1 0. 7   A p pe n di x 7 ).
I nterc urre nt e ve nt(s): All data c ollecte d after a n i nterc urre nt e ve nt of s u bse q ue nt a nti-
ca ncer t hera p y are e xcl u de d.
P o p ulati o n -le vel s u m mar y: Perce nta ge of C R/ C Ri a m o n g t he As-treate d p o p ulati o n.
9. 2. S a m ple Size Deter mi n ati o n
A si n gle -sta ge desi g n will be use d t o test t he n ull h yp ot hesis ( H 0) wit h 1 -si de d 
0. 0 2 5 si g nifica nce le vel t hat C R/ C Ri is ≤3 7 %.
A sa m ple size of 4 4 patie nts is pla n ne d t o pr o vi de at least 9 0 % p o wer t o reject t he 
n ull h y p ot hesis ( H 0: C R/ C Ri rat e ≤3 7 %) w he n t he tr ue C R/ C Ri rate ≥6 1 % u n der 
t he 1- si de d si g nifica nce le vel 0. 0 2 5, base d o n si n gle bi n o mial pr o p orti o n test u n der 
n or mal a p pr o xi mati o n wit h e m pirical esti mate f or varia nce. 
Ass u mi n g e xactl y  4 4 patie nts are e nr olle d a n d treate d , t he n ull h yp ot hesis will be 
rejecte d a n d it will be c o ncl u de d t hat t he st u d y has de m o nstrate d t hat t he tr ue 
C R/ C Ri rate e xcee ds 3 7 % if 2 3 or m ore res p o n ders are o bser ve d.  H o we ver, at t he 
ti me of t he a nalys is, t he testi n g will de pe n d o n t he act ual n u m ber of patie nts 
e nr olle d.
A s ufficie nt n u m ber of partici pa nts will be scree ne d t o ac hie ve 4 4 partici pa nts e nr olle d a n d 
recei ve d at least o ne d ose of i n ot uz u ma b oz o ga mici n.
9. 3. P o p ul ati o ns f or A n al ysis
F or p ur p oses of a nal y sis, t he f oll o wi n g p o p ulati o ns are defi ne d:
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 6
P o p ul ati o n
Descri pti o n
Per Pr ot oc ol P o p ulati o n
All patie nts w h o meet all of t he f oll o wi n g criteria:
1.
Recei ve at least o ne d ose of i n vesti gati o nal pr o d uct 
(i n ot uz u ma b oz o ga mici n).
2.
N o maj or pr ot oc ol vi olati o ns.  Maj or vi olati o ns 
i ncl u de fail ure t o satisf y maj or e ntr y criteria or life -
t hreate ni n g d osi n g err or.
3.
A n a de q uate baseli ne disease assess me nt.
Safet y /As -Treate d
All partici pa nts w h o ta ke at least 1 d ose of i n vesti gati o nal 
pr o d uct.
P K c o nce ntrati o n
S u bset of t he As -Treate d a nal ys is set a n d will i ncl u de 
partici pa n ts w h o ha ve at least o ne p ost-d ose c o nce ntrati o n 
meas ure me nt a b o ve t he l o wer li mit of q ua ntitati o n.
I m m u n o ge nicity
S u bset of t he As -Treate d a nal ys is set a n d will i ncl u de 
partici pa nts w h o recei ve at least 1 d ose of i n vesti gati o nal 
pr o d uct (i n ot uz u ma b oz o ga mici n) a n d ha ve at least 1 A D A 
sa m ple c ollecte d a n d a nal yze d f or i m m u n o ge nicit y
9. 4. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore data base l oc k a n d will descri be t he 
partici pa nt p o p ulati o ns t o be i ncl u de d i n t he a nal y ses, a n d pr oce d ures f or acc o u nti n g f or 
missi n g, u n use d, a n d s p uri o us data.  T his secti o n is a s u m mar y  of t he pla n ne d statistical 
a nal ys es of t he pri mar y a n d sec o n dar y e n d p oi nts.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 7
9. 4. 1. Effic ac y A n al yses
E n d p oi nt
St atistic al A n al ysis Met h o ds
Pri mar y
C R/ C Ri per i n vesti g at or’s assess me nt

Usi n g n or mal a p pr o xi mati o n met h o d wit h e m pirical esti mate f or 
varia nce t o test t he h y p ot hesis H 0: C R/ C Ri rate ≤3 7 % vs H a: 
C R/ C Ri rate ≥6 1 %.  

Esti mate t he C R/ C Ri rate per i n vesti gat or’s assess me nt a n d 
c orres p o n di n g t w o -si de d 9 5 % CI usi n g n or mal a p pr o xi mate 
met h o d f or all partici pa nts recei ve d at least o ne d ose of 
i n vesti gati o nal pr o d uct fr o m t he ti me of first d ose u ntil t he e n d 
of treat me nt. 

T his a nal y sis is base d o n As-Treate d p o p ulati o n.  Patie nts wit h 
deat h pri or t o first p ost - baseli ne assess me nt, i na de q uate baseli ne 
assess me nt, ne w a nti -ca ncer t hera p y starte d pri or t o first 
p ost -baseli ne assess me nt, a n d a ll p ost-baseli ne disease 
assess me nts missi n g will be c o nsi dere d as n o n -res p o n ders.  Data 
c ollecte d after t he e n d of treat me nt will be e xcl u de d fr o m t he 
a nal ys is. 

Se nsiti vit y  a nal ysis ma y be c o n d ucte d i n t he per-pr ot oc ol 
a nal ys is set. 
Sec o n dar y
D o R

D o R will be defi ne d as t he ti me fr o m date of first res p o nse i n 
res p o n ders ( C R/ C Ri) t o t he date of disease pr o gressi o n (ie, 
o bjecti ve pr o gressi o n, rela pse fr o m C R/ C Ri, treat me nt 
disc o nti n uati o n d ue t o gl o bal deteri orati o n of healt h stat us), 
deat h d ue t o a n y ca use, w hic he ver occ urs first (i ncl u di n g p ost -
st u d y treat me nt f oll o w-u p disease assess me nts). 

Usi n g t he Ka pla n -Meier met h o d, pl ot t he esti mati o n of t he 
s ur vi val f u ncti o n a n d esti mate its ass ociate d statistics o n D o R 
(i ncl u di n g t he me dia n D o R wit h t w o-si de d 9 5 % CI) f or 
res p o n ders t o i n vesti gati o nal pr o d uct wit h o ut re gar d t o 
disc o nti n uati o n fr o m treat me nt.  T his a nal y sis is base d o n 
res p o n ders i n t he As-Treate d p o p ulati o n.  Patie nts wit h a n e ve nt 
m ore t ha n 2 8 wee ks after t he last a de q uate t u m or assess me nt 
w ill be ce ns ore d o n t he date of t he last a de q uate t u m or 
assess me nt t hat d oc u me nte d n o pr o gressi o n.  T he CI  f or t he 
me dia n D o R will be calc ulate d acc or di n g t o Br o o k me y er a n d 
Cr o wle y  met h o d.
M R D ne g ati vit y i n p atie nts ac hie vi n g C R/ C Ri .

T he perce nta ge of patie nts w h o ac hie ve M R D -ne gati vit y  
bet wee n t he date of C R/ C Ri a n d e n d of treat me nt will be 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 8
E n d p oi nt
St atistic al A n al ysis Met h o ds
a nal yz e d. A n d t he M R D -ne gati vit y  will be defi ne d as mali g na nt 
B l y m p h oc y tes occ urri n g at a fre q ue nc y of < 1 0 - 4.

T he n u m ber a n d perce nta ge of patie nts wit h M R D ne gati vit y  i n 
patie nts ac hie vi n g C R/ C Ri will be s u m marize d descri pti vel y 
wit h c orres p o n di n g t w o -si de d 9 5 % CI. T his a nalys is is base d o n 
res p o n ders i n t he As- Treate d p o p ulati o n. 
P F S

P F S will be defi ne d as t he ti me fr o m date of first d ose t o t he 
date of disease pr o gressi o n (ie, o bjecti ve pr o gressi o n, rela pse 
fr o m C R/ C Ri), or deat h d ue t o a ny ca use, w hic he ver occ urs 
first.

Usi n g t he Ka pla n -Meier met h o d, pl ot t he esti mati o n of t he 
s ur vi val f u ncti o n a n d esti mate its ass ociate d statistics o n P F S 
(i ncl u di n g t he me dia n P F S wit h t w o-si de d 9 5 % CI, t he P F S 
rates at cli nical mea ni n gf ul ti me p oi nts wit h t w o-si de d 9 5 % CI)
f or all partici pa nts recei ve d at least o ne d ose of i n vesti gati o nal 
pr o d uct wit h o ut re gar d t o disc o nti n uati o n fr o m t reat me nt.  T his 
a nal ys is is base d o n As Treate d p o p ulati o n.  Patie nts wit h o ut a 
P F S e ve nt at ti me of a nal ysis will be ce ns ore d at t he date of last 
vali d disease assess me nt.  Patie nts wit h d oc u me ntati o n of a P F S 
e ve nt after a n u nacce pta bl y  l o n g i nter val ( > 28 wee ks if t here 
was p ost -baseli ne disease assess me nt, or > 1 2 wee ks if t here was 
n o p ost -baseli ne assess me nt) si nce t he pre vi o us disease 
assess me nt will be ce ns ore d at t he date of t he pre vi o us 
assess me nt ( date of first d ose if n o p ost baseli ne assess me nt). 
T he CI  f or t he me dia n P F S will be calc ulate d acc or di n g t o 
Br o o k me yer a n d Cr o wle y  met h o d, a n d t he CIs f or t he s ur vi val 
f u ncti o n esti mates at t he ti me p oi nts will be deri ve d usi n g t he 
l o g(-l o g) met h o d

A se nsiti vit y  a nalys is of P F S will be base d o n defi ni n g PF S as 
t he ti me fr o m date of first d ose t o t he date of disease pr o gressi o n 
(ie, o bjecti ve pr o gressi o n, rela pse fr o m C R/ C Ri, treat me nt 
disc o nti n uati o n d ue t o gl o bal deteri orati o n of healt h stat us), 
deat h d ue t o a n y ca use, or starti n g ne w i n d ucti o n 
t hera py/ p o st-t hera p y H S C T wit h o ut ac hie vi n g C R/ C Ri, 
w hic he ver occ urs first (i ncl u di n g p ost -st u d y treat me nt f oll o w- u p 
disease assess me nts).
O S

O S will be defi ne d as t he ti me fr o m first d ose t o deat h d ue t o 
a n y ca use. 

Usi n g t he Ka pla n -Meier met h o d, pl ot t he esti mati o n of t he 
s ur vi val f u ncti o n a n d esti mate its ass ociate d statistics o n O S 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 7 9
E n d p oi nt
St atistic al A n al ysis Met h o ds
(i ncl u di n g t he me dia n O S wit h t w o-si de d 9 5 % CI, t he O S rates 
at cli nical mea ni n gf ul ti me p oi nts wit h t w o -si de d 9 5 % CI) f or 
patie nts recei ve d at least o ne d ose of i n vesti gati o nal pr o d uct
wit h o ut re gar d t o disc o nti n uati o n fr o m treat me nt a n d start of 
ne w a nti -ca ncer t hera p y.  T his a nal ysis is base d o n As-Treate d 
p o p ulati o n.  Patie nts wit h o ut c o nfir mati o n of deat h will be 
ce ns ore d o n date of last c o ntact.  T he CI f or t he me dia n O S will 
be ca lc ulate d acc or di n g t o Br o o k me yer a n d Cr o wle y met h o d, 
a n d t he CIs f or t he s ur vi val f u ncti o n esti mates at t he ti me p oi nts 
will be deri ve d usi n g t he l o g( -l o g) met h o d.
H S C T

H S C T p ost i n ot uz u ma b oz o ga mici n will be s u m marize d b y  
descri pti ve a nal y ses (ie, t he n u m ber, perce nt of patie nts 
u n der we nt H S C T al o n g wit h 2 -si de d 9 5 % CI).  T his a nal ysis is 
base d o n As Treate d p o p ulati o n. 
9. 4. 2. S afet y A n al yses
T he safet y a nal ys is will be c o n d ucte d o n t he safet y p o p ulati o n. A Es will be prese nte d wit h 
a n d wit h o ut re gar d t o ca usalit y  base d o n t he I n vesti gat or’s j u d g me nt.  T he fre q ue nc y of 
o verall t o xicit y , cate g orize d b y t o xicit y Gra des 1 t hr o u g h 5, will be descri be d.  A d diti o nal 
s u m maries will be pr o vi de d f or A Es t hat are o bser ve d wit h hi g her fre q ue nc y. 
Rate of V O D/ S O S (t otal, o n -st u d y treat me nt, a n d p ost-H S C T) will be s u m marize d i n t he 
safety p o p ulati o n.  Descri pti ve a nal yses (ie, t he n u m ber, perce nt of patie nts wit h V O D al o n g 
wit h 2 -si de d 9 5 % CI) will be prese nte d.  A s u b gr o u p a nalys is will als o be c o n d ucte d f or 
V O D i n patie nts w h o u n der g o H S C T i n t he safet y p o p ulati o n.  A nal yses i n t his s u b gr o u p will 
i ncl u de a n assess me nt of V O D i n all patie nts wit h a s u bse q ue nt H S C T as well as i n patie nts 
w h o pr ocee d t o H S C T directl y after i n ot uz u ma b oz o ga mici n treat me nt ( wit h o ut a n 
i nter ve ni n g i n d ucti o n t hera py).  All k n o w n cases of V O D, re gar dless of ca usalit y a n d 
se verity, will be re p orte d as S A Es f or t he e ntire d urati o n of s t u d y partici pati o n, i ncl u di n g t he 
F oll o w -u p peri o d.
Dr u g e x p os ure will be s u m marize d usi n g descri pti ve statistics.
La b orat or y  data will be s u m marize d b y t he ty pe of la b orat or y test.  S u m mar y of La b orat or y 
a b n or malities will be prese nte d b y ma xi m u m C T C A E Gra de.  A s hift s u m mar y  of baseli ne 
gra de b y ma xi m u m p ost -baseli ne gra de will als o be prese nte d.  Para meters w hic h ca n n ot be 
gra de d will be s u m marize d relati ve t o t he n or mal ra n ge (ie, hi g her or l o wer t ha n n or mal 
ra n ge).  Vital si g ns data will be s u m marize d usi n g descri pti ve statistics ( mea n, sta n dar d 
de viati o n, me dia n, q uartiles, mi ni m u m, a n d ma xi m u m) of act ual val ues a n d c ha n ge fr o m 
baseli ne f or eac h n o mi nal visit o ver ti me (ie, u nsc he d ule d assess me nts will be e xcl u de d).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 0
T he n u m ber a n d perce nta ge of patie nt s wit h a b n or mal fi n di n gs i n p h ysical e xa mi nati o n will 
be s u m marize d b y  b o d y s yste m f or eac h n o mi nal assess me nt ti me p oi nt.
E x pl orat or y a nal ys is ma y be perf or me d t o assess relati o ns hi p bet wee n C D 2 2 a n d efficac y  
(i ncl u di n g M R D) a n d/ or safety o utc o mes if data per mit, t he details will be decr y pte d i n t he
S A P .
9. 4. 3. Ot her A n al yses 
9. 4. 3. 1. P h ar m ac o ki netics A n al ysis
A nal y ses of t he P K data will be c o n d ucte d o n t he P K c o nce ntrati o n p o p ulati o n.
Descri pti ve s u m mar y  statistics will be pr o vi de d f or plas ma c o nce ntrati o n at sc he d ule d visits.  
Plas ma c o nce ntrati o n val ue bel o w t he li mit of q ua ntitati o n will be treate d as zer o i n t he 
descri pti ve statistics calc ulati o n.  N, mea n, sta n dar d de viati o n, perce nt c oefficie nt of 
variati o n ( % C V), me dia n, ra n ge, ge o metric mea n a n d ge o metric % C V wil l be prese nte d by 
c ycle, da y a n d n o mi nal ti me i n ta b ular f or m. 
9. 4. 3. 2. P o p ul ati o n P h ar m ac o ki netic ( P K) A n al ysis M o deli n g
P K data fr o m t his st u d y  ma y be a nalyz e d usi n g c o m part me ntal m o deli n g a p pr oac hes a n d 
ma y  als o be p o ole d wit h data fr o m ot her st u dies t o i n vestigate a n y ass ociati o n bet wee n 
i n ot uz u ma b oz o ga mici n e x p os ure a n d bi o mar kers or si g nifica nt safety a n d/ or efficac y 
e n d p oi nts.  T he res ults of t hese m o deli n g a nal ys es, if perf or me d, will be re p orte d se paratel y 
fr o m t he cli nical st u dy re p ort.
9. 4. 3. 3. I m m u n o ge nicit y A nal ysis
T he perce nta ge of patie nts wit h p ositi ve A D A a n d N A b will be s u m marize d.  T he ma g nit u de 
(titer), ti me of o nset a n d d urati o n of A D A/ N A b will als o be descri be d if data per mit.
9. 5. I nteri m A n al yses
N o f or mal i nteri m a nal ys is will be c o n d ucte d f or t his st u dy. As t his is a n o pe n la bel 
st u d y, t he s p o ns or ma y c o n d uct re vie ws of t he data d uri n g t he c o urse of t he st u d y f or t he 
p ur p ose of safet y assess me nt.
9. 5. 1. D at a M o nit ori n g C o m mittee 
T his st u d y  will n ot use a data m o nit ori n g c o m mittee ( D M C).
9. 5. 2. He p atic E ve nts A dj u dic ati o n C o m mitee ( H E A C)
T he st u d y will als o use a H E A C. T his a dj u dicati o n c o m mittee will re vie w safet y data wit h
res pect t o t he p ote ntial cases of ve n o -occl usi ve disease a n d H y’s la w cases.  A d diti o nal 
i nf or mati o n is i n H E A C c harters ma i ntai ne d b y t he S p o ns or.  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 1
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S
1 0. 1. A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns
1 0. 1. 1. Re g ul at or y a n d Et hic al C o nsi der ati o ns
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:
C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes i ncl u di n g t he 
Declarati o n of Helsi n ki a n d C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical 
Scie nces ( CI O M S) I nter nati o nal Et hical G ui deli nes;
A p plica ble I nter nati o nal C o u ncil f or Har m o nisati o n (I C H) G o o d Cli nical Practice 
( G C P) g ui deli nes;
A p plica ble la ws a n d re g ulati o ns, i ncl u di n g a p plica ble pri vac y  la ws.
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D, S R S D(s), a n d ot her rele va nt d oc u me nts (e g, 
a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y  t he s p o ns or a n d s u b mitte d t o a n IR B/ E C 
b y  t he i n vesti gat or a n d re vie we d a n d a p pr o ve d by t he IR B/ E C bef ore t he st u d y  is i nitiate d.
A n y  a me n d me nts t o t he pr ot oc ol will re q uire I R B/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate 
hazar d t o st u d y  partici pa nts.
T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:
Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y  t o t he I R B/ E C a n n uall y or 
m ore fre q ue ntl y  i n acc or dance wit h t he re q uire me nts, p olicies, a n d pr oce d ures 
esta blis he d b y t he I R B/ E C;
N otif y i n g t he I R B/ E C of S A Es or ot her si g nifica nt safety fi n di n gs as re q uire d b y 
I RB/ E C pr oce d ures;
Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C o de of Fe deral Re g ulati o ns ( C F R), IC H g ui deli nes, t he 
I RB/ E C, E ur o pea n re g ulati o n 5 3 6/ 2 0 1 4 f or cli nical st u dies (if a p plica ble), a n d all 
ot her a p plica ble l ocal re g ulati o ns.
1 0. 1. 1. 1. Re p orti n g of S afet y Iss ues a n d Seri o us Bre ac hes of t he Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of t he i n vesti gati o nal 
pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y. 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 2
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt safety meas ures 
ta ke n by t he i n vesti gat or t o pr otect t he st u d y partici pa nts a gai nst a n y i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of I C H G C P t hat t he i n vesti gat or bec o mes a ware 
of.
1 0. 1. 2. Fi n a nci al Discl os ure
I n vesti gat ors a n d s u bi n vesti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate fi na ncial 
i nf or mati o n as re q ueste d t o allo w t he s p o ns or t o s u b mit c o m plete a n d acc urate fi na ncial 
certificati o n or discl os ure state me nts t o t he a p pr o priate re g ulat or y  a ut h orities.  In vesti gat ors 
are res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t he c o urse of t he st u d y 
a n d f or 1 ye ar after c o m pleti o n of t he st u d y .
1 0. 1. 3. I nf or me d C o nse nt Pr ocess
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y , 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt or his/ her le gall y a ut h orize d re prese ntati ve 
a n d a ns wer all q uesti o ns re gar di n g t he st u d y. T he partici pa nt or his/ her le gall y a ut h orize d 
re prese ntati ve s h o ul d be gi ve n s ufficie nt ti me a n d o p p ort u nit y t o as k q uesti o ns a n d t o deci de 
w het her or n ot t o partici pate i n t h e trial.
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y .  Partici pa nts or t heir 
le gall y a ut h orize d re prese ntati ve (if all o we d b y l ocal re g ulati o ns) will be re q uire d t o si g n a 
state me nt of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, l ocal re g ulati o ns, 
I C H g ui deli nes, pri vac y a n d data pr otecti o n re q uire me nts, w here a p plica ble, a n d t he I R B/ E C 
or st u d y  ce nter.
T he i n vesti gat or m ust e ns ure t hat eac h st u d y  partici pa nt or his or her le gall y a ut h orize d 
re prese ntati ve is f ull y i nfor me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y , t he s hari n g of 
data relate d t o t he st u d y , a n d p ossi ble ris ks ass ociate d wit h partici pati o n, i ncl u di n g t he ris ks 
ass ociate d wit h t he pr ocessi n g of t he partici pa nt’s pers o nal data. 
T he partici pa nt or his/ her le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat his/ her
pers o nal st u d y relate d data will be use d b y t he s p o ns or i n acc or da nce wit h l ocal data 
pr otecti o n la w. T he le vel of discl os ure m ust als o be e x plai ne d t o t he partici pa nt or his/ her
le gally a ut h orize d re prese ntati ve.
T he partici pa nt or his/ her le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat t heir 
me dical rec or ds ma y  be e xa mi ne d b y Cli nical Q ualit y Ass ura nce a u dit ors or ot her a ut h orize d 
pers o n nel a p p oi nte d b y t he s p o ns or, b y a p pr o pri ate IR B/ E C me m bers, a n d b y  i ns pect ors 
fr o m re g ulat or y a ut h orities.
T he i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y  partici pa nt or his or her le gally 
a ut h orize d re prese ntati ve is f ull y  i nf or me d a b o ut his or her ri g ht t o access a n d c orrect his or 
her pe rs o nal data a n d t o wit h dra w c o nse nt f or t he pr ocessi n g of his or her pers o nal data.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 3
T he me dical rec or d m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt was o btai ne d 
bef ore t he partici pa nt was e nr olle d i n t he st u d y  a n d t he date t he writte n c o nse nt was o btai ne d.  
T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D.
Partici pa nts or t heir le gall y  a ut h orize d re prese ntati ve m ust be rec o nse nte d t o t he m ost c urre nt 
I RB/ E C versi o n of t he I C D(s) d uri n g t heir partici pati o n i n t he st u d y  as re q uire d per l ocal 
re g ulati o ns.
A c o p y of t he I C D(s) m ust be pr o vi de d t o t he partici pa nt or t he partici pa nt’s le gally 
a ut h orize d re prese ntati ve (if all o we d b y l ocal re g ulati o ns) .
Partici pa nts w h o are rescree ne d are re q uire d t o si g n a ne w I C D.
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts’ pers o nal data will be st ore d at t he st u d y  site i n e ncry pte d electr o nic a n d/ or pa per 
f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y 
a ut h orize d st u d y staff ha ve access.  T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pers o n al data ca n be rec o vere d i n t he e ve nt of 
disaster.  I n t he e ve nt of a p ote ntial pers o nal data breac h, t he st u d y  site s hall be res p o nsi ble 
f or deter mi ni n g w het her a pers o nal data breac h has i n fact occ urre d a n d, if s o, pr o vi di n g 
breac h n otificati o ns as re q u ire d b y la w.
T o pr otect t he ri g hts a n d free d o ms of nat ural pers o ns wit h re gar d t o t he pr ocessi n g of 
pers o nal data, partici pa nts will be assi g ne d a si n gle, partici pa nt s pecific n u merical c o de.  A n y 
partici pa nt rec or ds or data sets t hat are tra nsferre d t o t h e s p o ns or will c o ntai n t he n u merical 
c o de; partici pa nt na mes will n ot be tra nsferre d.  All ot her i de ntifia ble data tra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt s pecific c o de.  T he st u d y site will 
mai ntai n a c o nfi de ntial list of partici pa nts w h o partici pate d i n t he st u d y , li n ki n g eac h 
partici pa nt’s n u merical c o de t o his or her act ual i de ntit y .  I n case of data tra nsfer, t he s p o ns or 
will pr otect t he c o nfi de ntialit y  of partici pa nts’ pers o nal data c o nsiste nt wit h t he cli nical st u d y 
a gree me nt a n d a p plica ble pri vac y  la ws.
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u d y-relate d data are 
sec ure d by t ec h nical a n d or ga nizati o nal sec urit y m eas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nla wf ul l oss, al terati o n, or u na ut h orize d discl os ure or access. 
T he s p o ns or mai ntai ns sta n dar d o perati n g pr oce d ures o n h o w t o res p o n d i n t he e ve nt of 
u na ut h orize d access, use, or discl os ure of s p o ns or i nf or mati o n or s y ste ms.
1 0. 1. 5. C o m mittees Str uct ure
1 0. 1. 5. 1. D at a M o nit ori n g C o m mittee
T his st u d y  will n ot use a n E-D M C.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 4
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr o u g h p osti n g t he 
res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E ur o pea n Cli nical Trials 
Data base ( E u dra C T), a n d/ or w w w. pfizer.c o m, a n d ot her p u blic re gistries i n acc or da nce wit h 
a p plica ble l ocal la ws/re g ulati o ns.  I n a d diti o n, Pfizer re p orts st u d y  res ults o utsi de of t he 
re q uire me nts of l ocal la ws/re g ulati o ns p urs ua nt t o its sta n dar d o perati n g pr oce d ures ( S O Ps).
I n all cases, st u dy res ults are re p orte d b y Pfizer i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t he o utc o me of t he st u d y or t he c o u ntr y i n 
w h ic h t he st u d y was c o n d ucte d.
w w w.cli nicaltrials. g o v
Pfizer p osts cli nical trial U S Basic Res ults o n w w w.cli nicaltrials. g o v f or Pfizer -s p o ns ore d 
i nter ve nti o nal st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safety a n d/ or efficac y of a 
pr o d uct, re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y  is c o n d ucte d.  U S Basic 
Res ults are ge nerall y s u b mitte d f or p osti n g wit hi n 1 year of t he pri mar y c o m pleti o n date 
( P C D) f or st u dies i n a d ult p o p ulati o ns or wit hi n 6 m o nt hs of t he P C D f or st u dies i n pe diatric 
p o p ulati o ns.
P C D is defi ne d as t he date t hat t he fi nal partici pa nt was e xa mi ne d or recei ve d a n i nter ve nti o n 
f or t he p ur p oses of fi nal c ollecti o n of data f or t he pri mar y o utc o me, w het her t he cli nical 
st u d y c o ncl u de d acc or di n g t o t he pres pecifie d pr ot oc ol or was ter mi nate d.
E u dra C T
Pfizer p osts E ur o pea n U ni o n ( E U) Basic Res ults o n E u dra C T f or all Pfizer s p o ns ore d 
i nter ve nti o nal st u dies t hat are i n sc o pe of E U re q uire me nts.  E U Basic Res ults are s u b mitte d 
f or p osti n g wit hi n 1 year of t he P C D f or st u dies i n a d u lt p o p ulati o ns or wit hi n 6 m o nt hs of 
t he P C D f or st u dies i n pe diatric p o p ulati o ns.
w w w. pfizer.c o m
Pfizer p osts p u blic discl os ure s y n o pses ( C S R s y n o pses i n w hic h a n y data t hat c o ul d be use d 
t o i de ntif y i n di vi d ual partici pa nts ha ve bee n re m o ve d) o n w w w. pfizer.c o m f or Pfizer
s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he U S Basic Res ults d oc u me nt is p oste d t o 
w w w.cli nicaltrials. g o v.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 5
D oc u me nts wit hi n mar keti n g a ut h orizati o n pac ka ges/s u b missi o ns
Pfizer c o m plies wit h t he E ur o pea n U ni o n P olic y  0 0 7 0, t he pr oacti ve p u blicati o n of cli nical 
data t o t he E ur o pea n Me dici nes A ge nc y  ( E M A) we bsite.  Cli nical data, u n der P hase 1 of t his 
p olic y , i ncl u des cli nical o ver vie ws, cli nical s u m maries, C S Rs, a n d a p pe n dices c o ntai ni n g t he 
pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m p le C R Fs, a n d statistical met h o ds.  Cli nical data, 
u n der P hase 2 of t his p olic y , i ncl u des t he p u blis hi n g of i n di vi d ual partici pa nt data.  P olic y 
0 0 7 0 a p plies t o ne w mar keti n g a ut h orizati o n a p plicati o ns s u b mitte d via t he ce ntralize d 
pr oce d ure si nce 0 1 Ja n uary 2 0 1 5 a n d a p plicati o ns f or li ne e xte nsi o ns a n d f or ne w i n dicati o ns 
s u b mitte d via t he ce ntralize d pr oce d ure si nce 0 1 J ul y 2 0 1 5.
Data S hari n g
Pfizer pr o vi des researc hers sec ure access t o patie nt le vel data or f ull C S Rs f or t he p ur p oses 
of “ b o na fi de scie ntific researc h” t hat c o ntri b ute t o t he scie ntific u n dersta n di n g of t he 
disease, tar get, or c o m p o u n d class.  Pfizer will ma ke a vaila ble data fr o m t hese trials 2 4 
m o nt hs after st u d y  c o m pleti o n.  Patie nt le vel data will be a n o n ymize d i n acc or da nce wit h 
a p plica ble pri vac y la ws a n d re g ulati o ns. C S Rs will ha ve pers o nall y i de ntifia ble i nf or mati o n 
re dacte d.
Data re q uests are c o nsi dere d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal yses.  Researc h tea ms m ust i ncl u de a bi ostat isticia n.  Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uesti n g access f or c o m mercial/c o m petiti ve or le gal p ur p oses.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 6
1 0. 1. 7. D at a Q u alit y Ass ur a nce
All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or electr o nic C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e g, la b orat or y data).  T he i n vesti gat or is 
res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F.
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt.
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n e ncr y pte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties.
T he i n vesti gat or m ust per mit st u d y -relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce data d oc u me nts.  T his 
verificati o n ma y  als o occ ur after st u d y  c o m pleti o n.  It is i m p orta nt t hat t he i n vesti gat or(s) 
a n d t heir rele va nt pers o n nel are a vaila ble d uri n g t he m o nit ori n g visits a n d p ossi ble a u dits or 
i ns pecti o ns a n d t hat s ufficie nt ti me is de v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y , i ncl u di n g t he defi niti o n of st u d y-critical data ite ms 
a n d pr ocesses (e g, ris k -base d i nitiati ves i n o perati o ns a n d q ualit y , s uc h as ris k ma na ge me nt 
a n d miti gati o n strate gies a n d a nal yt ical ris k-base d m o nit ori n g), met h o ds, res p o nsi bilities, a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual, or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g pla n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C Ds, pertai ni n g t o t he c o n d uct of t his st u d y  m ust 
be retai ne d b y t he i n vesti gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d.  N o rec or ds ma y be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or.  N o rec or ds ma y be 
tra nsferre d t o a n other l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or.  T he 
i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urely f or as l o n g as t he y are 
mai ntai ne d.
W he n partici pa nt data is t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h data 
are pr o m ptl y a n d irre v oca bl y delete d fr o m all s yste ms.
T he i n vesti gat or will n otif y  t he s p o ns or or its a ge nts i m me diatel y of a ny re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y.  F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n.  T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt's me dical rec or ds.  T he i n vesti gat or will pr o m ptl y  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 7
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt.  Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y a ut h orities, t he in vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs.
1 0. 1. 8. S o urce D oc u me nts
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grit y of t he data c ollecte d.  S o urce d oc u me nts are file d at t he i n vesti gat or site.
Data re p orte d o n t he C R F or e ntere d i n t he electr o nic C R F (e C R F) t hat are tra nscri be d fr o m 
s o urce d oc u me nts m ust be c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be 
e x plaine d.  T he i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer 
rec or ds, de pe n di n g o n t he st u d y.  Als o, c urre nt me dical rec or ds m ust be a vaila ble.
Defi niti o n of w hat c o nstit utes s o urce data , a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me n t L ocat or, w hic h is mai ntai ne d b y t he s p o ns or.
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he Data Ma na ge me nt 
Pla n, w hic h is mai ntai ne d b y  t he s p o ns or.
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce data) t hat s u p p ort s t he 
i nf or mati o n e ntere d i nt o t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of parti ci pa nts are bei n g pr otecte d; a n d t hat t he st u d y  is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y  
a gree me nts, t he I C H G C P g ui deli nes, a n d all a p plica ble re g ulat or y  re q uire me nts.
1 0. 1. 9. St u d y a n d Site Cl os ure
T he st u d y  start date is t he date o n w hic h t he cli nical st u d y  will be o pe n f or recr uit me nt of 
partici pa nts.
T he first act of recr uit me nt is t he date of t he first partici pa nt’s first visit a n d will be t he st u d y  
start date.
T he s p o ns or desi g nee reser ves t he ri g ht t o cl ose t he st u d y  site or ter mi nate t he st u d y at a n y 
ti me f or a ny reas o n at t he s ole discreti o n of t he s p o ns or, i ncl u di n g ( b ut n ot li mite d t o) 
re g ulat or y a ut h ority decisi o n, c ha n ge i n o pi ni o n of t he I R B/ E C, or c ha n ge i n be nefit -ris k 
assess me nt.  St u d y  sites will be cl ose d u p o n st u d y c o m pleti o n.  A st u d y  site is c o nsi dere d 
cl ose d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies ha ve bee n c ollecte d a n d a st u d y site 
cl os ure visit has bee n perf or me d.
T he i n vesti gat or ma y  i nitiate st u d y site cl os ure at a n y ti me u p o n n otificati o n t o t he s p o ns or if 
re q ueste d t o d o s o by t he res p o nsi ble I R B/ E C or if s uc h ter mi nati o n is re q uire d t o pr otect t he 
healt h of st u d y  partici pa nts.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 8
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or ma y i ncl u de b ut are n ot li mite d 
t o:
Fail ure of t he i n vesti gat or t o c o m pl y  wit h t he pr ot oc ol, t he re q uire me nts of t he 
I RB/ E C or l ocal healt h a ut h orities, t he s p o ns or's pr oce d ures, or G C P g ui deli nes;
I na de q uate recr uit me nt of partici pa nts b y  t he i n vesti gat or;
Disc o nti n uati o n of f urt her st u d y  inter ve nti o n de vel o p me nt.
If t he st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
i n vesti gat ors, t he E Cs/I R Bs, t he re g ulat or y a ut h orities, a n d a n y C R O(s) use d i n t he st u d y of 
t he reas o n f or ter mi nati o n or s us pe nsi o n, as s pecifie d b y t he a p plica ble re g ulat or y 
re q uire me nts.  T he i n vesti gat or s hall pr o m ptl y i nf or m t he partici pa nt a n d s h o ul d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f oll o w - u p.
St u d y  ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt.  If t here is a ny c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol, t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 0. P u blic ati o n P olic y
T he res ults of t his st u d y  ma y be p u blis he d or prese nte d at scie ntific meeti n gs by t he 
i n vesti gat or after p u blicati o n of t he o verall st u d y res ults or 1 year after e n d of t he st u d y ( or 
st u d y ter mi nati o n), w hic he ver c o mes first. 
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns 
s uc h as sec o n dar y ma n uscri pts, a n d s u b mits all ma n uscri pts or a bstracts t o t he s p o ns or 
3 0 da y s bef ore s u b missi o n.  T his all o ws t he s p o ns or t o pr otect pr o prietar y i nf or mati o n a n d t o 
pr o vi de c o m me nts a n d t he i n vesti gat or will, o n re q uest, re m o ve a n y pre vi o usl y  u n discl ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a ny st u d y or Pfizer i nter ve nti o n relate d 
i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or u n dersta n di n g of t he 
st u d y res ults.
F or all p u blicati o ns relati n g t o t he st u d y, t he i n vesti gat or will c o m pl y wit h rec o g nize d et hical 
sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g t h ose esta blis he d b y  t he 
I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors.
T he s p o ns or will c o m pl y  wit h t he re q uire me nts f or p u blicati o n of t he o verall st u d y res ults 
c o veri n g all i n vesti gat or sites.  I n acc or da nce wit h sta n dar d e dit orial a n d et hical practice, t he 
s p o ns or will s u p p ort p u blicati o n of m ultice nter st u dies o nl y i n t heir e ntiret y a n d n ot as 
i n di vi d ual site data.  In t his case, a c o or di nati n g i n vesti gat or will be desi g nate d b y  m ut ual 
a gree me nt.
A ut h ors hi p of p u blicati o ns f or t he o verall st u d y  res ults will be deter mi ne d b y m ut ual 
a gree me nt a n d i n li ne wit h Inter nati o nal C o m mittee of Me dical J o ur nal E dit ors a ut h ors hi p 
re q uire me nts. 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 8 9
If p u blicati o n is a d dresse d i n t he cli nical st u d y a gree me nt, t he pu blicati o n p olic y  set o ut i n 
t his secti o n will n ot a p pl y.
1 0. 1. 1 1. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al
T he c o ntact i nf or mati o n f or t he s p o ns or's M QI f or t he st u d y  is d oc u me nte d i n t he st u d y 
c o ntact list l ocate d i n t he st u d y  tea m o n de ma n d ( S T o D) s yste m.  
T o f acilitate access t o t he i n vesti gat or a n d t he s p o ns or's M QI f or st u d y- relate d me dical 
q uesti o ns or pr o ble ms fr o m n o nst u d y  healt hcare pr ofessi o nals, partici pa nts are pr o vi de d wit h 
a n E C C at t he ti me of i nf or me d c o nse nt.  T he E C C c o ntai ns, at a mi ni m u m, (a) p r ot oc ol a n d 
st u d y i nter ve nti o n i de ntifiers, ( b) partici pa nt’s st u d y i de ntificati o n n u m ber, (c) site 
e mer ge nc y p h o ne n u m ber acti ve 2 4 h o urs/ da y, 7 da ys per wee k, a n d ( d) Pfizer Call Ce nter 
n u m ber.
T he E C C is i nte n de d t o a u g me nt, n ot re place, t he esta blis he d c o m m u nicati o n pat h wa ys 
bet wee n t he partici pa nt, a n d t heir i n vesti gat or a n d site staff, a n d bet wee n t he i n vesti gat or a n d 
s p o ns or st u d y tea m. T he E C C is o nl y t o be use d b y healt hcare pr ofessi o nals n ot i n v ol ve d i n 
t he researc h st u d y, as a mea ns of reac hi n g the i n vesti gat or or site staff relate d t o t he care of a 
partici pa nt. T he Pfizer Call Ce nter n u m ber is t o be use d w he n t he i n vesti gat or a n d site staff 
are u na vaila ble. T he Pfizer Call Ce nter n u m ber is n ot f or use b y t he partici pa nt directl y;  if a 
partici pa nt calls t hat n u m ber directl y, t he y will be directe d bac k t o t he i n vesti gat or site..
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 0
1 0. 2. A p pe n di x 2: Cli nic al L a b or at or y Tests
T he f oll o wi n g safet y la b orat or y  tests will be perf or me d at ti mes defi ne d i n t he S o A secti o n of 
t his pr ot oc ol.  A d diti o nal la b orat or y res ults ma y be re p orte d o n t hese sa m ples as a res ult of 
t he met h o d of a nalys is or t he t ype of a nal yz er use d b y t he cli nical la b orat or y; or as deri ve d 
fr o m calc ulate d val ues.  T hese a d diti o nal tests w o ul d n ot re q uire a d diti o nal c ollecti o n of 
bl o o d.  U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g 
t he st u d y t o assess a n y percei ve d safet y c o ncer ns.
T a ble 1 0 . Pr ot oc ol -Re q uire d S afet y L a b or at or y Assess me nts
He mat ol o g y
Pa nel
C he mistr y
Pa nel
C oa g ulati o n
Pa nel 2
Uri nal ysis 3
He patitis
Scree ni n g
Pre g na nc y 
Tests
W B C
c o u nt
wit h
differe ntial
i ncl u di n g bl ast
c o u nt 1
S o di u m
I N R or
pr ot hr o m bi n
ti me ( P T)
p H
He patitis B
s urface a nti ge n
( H bs A g)
F or fe male 
partici pa nts of 
c hil d beari n g 
p ote ntial, 
beta -h u ma n 
c h ori o nic 
g o na d otr o pi n 
( ß-H C G) 
ser u m or uri ne 
pre g na nc y test
P otassi u m
Acti vate d
partial
t hr o m b o plasti n
ti me or partial
t hr o m b o plasti n
ti me ( AP T T or
P T T)
Pr otei n or
al b u mi n
A nti b o d y t o
he patitis C
vir us (a nti-
H C V)
He m o gl o bi n
Ma g nesi u m
Uri ne pr otei n
t o creati ni ne
rati o3 ,5
Platelet c o u nt
Calci u m
Bl o o d/ he m o gl
o bi n
Creati ni ne
Ket o nes or
acet o ne
Al b u mi n
Ala ni ne
a mi n otra nsfera
se ( A L T)
As partate
a mi n otra nsfera
se ( A S T)
Gl uc ose
P h os p h or us
T otal Bilir u bi n
Direct bilir u bi n
o nl y if t otal is
ele vate d
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 1
T a ble 1 0 . Pr ot oc ol -Re q uire d S afet y L a b or at or y Assess me nts
He mat ol o g y
Pa nel
C he mistr y
Pa nel
C oa g ulati o n
Pa nel 2
Uri nal ysis 3
He patitis
Scree ni n g
Pre g na nc y 
Tests
Bl o o d urea
nitr o ge n
( B U N) or urea
Uric aci d or
urate
Al kali ne
p h os p hatase
Lactate
de h y dr o ge nase
( L D H)
Ga m ma -
gl uta m yl
tra ns pe pti dase
( G G T)
T otal pr otei n
A m ylase
a n d/ or Li pase 4
1.
Prefera bl y a bs ol ute val ues will be rec or de d i n t he C R F.  Perce nta ge will be rec or de d o nl y if t he a bs ol ute val ue is 
n ot re p orte d at t he l ocal la b orat or y.
2.
C oa g ulati o n: i ncl u des P T/I N R (c ollecte d at scree ni n g, u p t o 7 2 h o urs pre d ose of da y 1 of eac h c ycle a n d E O T).  
P T T or A P T T re q uire d at scree ni n g a n d e n d-of -treat me nt visits o nl y.
3.
Uri nal ysis: c o n d ucte d at scree ni n g, wit hi n 7 2 h o urs pri or t o d osi n g of C ycle 4 Da y 1, a n d t he 
e n d -of -treat me nt visit. Uri ne pr otei n t o creati ni ne rati o will be calc ulate d at
scree ni n g a n d E n d of treat me nt o nl y.
4.
B ot h a m ylase a n d li pase are re q uire d. H o we ver, at sites w here o ne or t he ot her is n ot perf or me d, eit her t he 
a m ylase or l i pase test will be d o ne.   T he sa me test will be
perf or me d t hr o u g h o ut t he st u d y.
5.
I n t he e ve nt t he site la b orat or y d oes n ot perf or m uri ne pr otei n meas ure me nts, a uri ne al b u mi n t o creati ni ne rati o 
will be o btai ne d a n d rec or de d i n t he C R F.
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 2
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E v al u ati n g, F oll o w -u p, a n d Re p orti n g
1 0. 3. 1. Defi niti o n of A E
A E Defi niti o n
A n A E is a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y 
partici pa nt , te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n, w het her or 
n ot c o nsi dere d relate d t o t he st u d y  i nter ve nti o n.
N O T E: A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), sy m pt o m, or disease ( ne w or e xacer bate d) 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n.
E ve nts Meeti n g
t he A E Defi niti o n
A n y  a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) 
or ot her safet y assess me nts (e g, E C G, ra di ol o gical sca ns, vital si g n 
meas ure me nts), i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y  
si g nifica nt i n t he me dical a n d scie ntific j u d gme nt of t he i n vesti gat or. A n y 
a b n or mal la b orat or y test res ults t hat meet a n y of t he c o n diti o ns bel o w m ust be 
rec or de d as a n A E:

Is ass ociate d wit h acc o m pa n yi n g sy m pt o ms;

Re q uires a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter ve nti o n;

Lea ds t o a c ha n ge i n st u d y d osi n g ( o utsi de of a n y pr ot oc ol-s pecifie d d ose 
a dj ust me nts) or disc o nti n uati o n fr o m t he st u d y , si g nifica nt a d diti o nal 
c o nc o mita nt dr u g treat me nt, or ot her t hera p y.
E xacer bati o n of a c hr o nic or i nter mitte nt pree xisti n g c o n diti o n, i ncl u di n g a n 
i ncrease i n eit her fre q ue nc y a n d/ or i nte nsit y of t he c o n diti o n.
Ne w c o n diti o ns detecte d or dia g n ose d after st u d y i nter ve nti o n a d mi nistrati o n, e ve n 
t h o u g h it ma y ha ve bee n prese nt bef ore t he start of t he st u d y.
Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n.
Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y  
i nter ve nti o n or a c o nc o mita nt me dicati o n.  O ver d ose per se will n ot be re p orte d 
as a n A E/ S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wi t h p ossi ble 
s uici dal/self- har mi n g i nte nt.  S uc h o ver d oses s h o ul d be re p orte d re gar dless of 
se q uelae.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 3
E ve nts N O T Meeti n g t he A E Defi niti o n
A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  
t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.
T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.
W orse ni n g of si g ns a n d s y m pt o ms of t he mali g na nc y  u n der st u d y s h o ul d be 
rec or de d as A Es i n t he a p pr o priate secti o n of t he C R F.  Disease pr o gressi o n 
assesse d b y meas ure me nt of mali g na nt lesi o ns o n ra di o gra p hs or ot her met h o ds 
s h o ul d n ot be re p orte d as A Es.
Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds t o t he pr oce d ure is A E.
Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nc e a d missi o n t o a h os pital).
A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt 
or detecte d at t he start of t he st u d y t hat d o n ot w orse n.
1 0. 3. 2. Defi niti o n of S A E
If a n e ve nt is n ot a n A E per defi niti o n a b o ve, t he n it ca n n ot be a n S A E e ve n if seri o us 
c o n diti o ns are met (e g, h os pitalizati o n f or si g ns/s y m pt o ms of t he disease u n der st u d y , deat h 
d ue t o pr o gressi o n of disease).
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose, meets 1 or 
m o re of t he criteri a liste d bel o w:
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g
T he ter m “life t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h t he 
partici pa nt was at ris k of deat h at t he ti me of t he e ve nt.  It d oes n ot refer t o a n e ve nt t hat 
h y p ot heticall y  mi g ht ha ve ca use d deat h if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n
I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n detai ne d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y war d f or o bser vati o n 
a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he p h ys icia n’s office or
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 4
o ut patie nt setti n g.  C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A Es.  If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us.  W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was necessar y, t he A E 
s h o ul d be c o nsi dere d seri o us.
H os pitalizati o n f or electi ve treat me nt of a pree xisti n g c o n diti o n t hat di d n ot w orse n fr o m 
baseli ne is n ot c o nsi dere d a n A E.
d.
Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y
T he ter m disa bilit y  mea ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y t o c o n d uct 
n or mal life f u ncti o ns.
T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or me dical 
si g nifica nce, s uc h as u nc o m plicate d hea dac he, na usea, v o miti n g, diarr hea, 
i nfl ue nza, a n d acci de ntal tra u ma (e g, s prai ne d a n kle) , t hat ma y  i nterfere wit h or 
pre ve nt e ver y d a y  life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pti o n.
e.
Is a c o n ge nit al a n o m al y/ birt h defect
f.
Is a s us pecte d tr a ns missi o n vi a a Pfizer pr o d uct of a n i nfecti o us a ge nt, 
p at h o ge nic or n o n -p at h o ge nic.  
T he e ve nt ma y  be s us pecte d fr o m cli nical sy m pt o ms or la b orat or y  fi n di n gs i n dicati n g a n 
i nfecti o n i n a partici pa nt e x p ose d t o a Pfizer pr o d uct. T he ter ms “s us pecte d 
tra ns missi o n” a n d “tra ns missi o n” are c o nsi dere d s yn o n y m o us. T hese cases are 
c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d cases b y p har mac o vi gila nce 
pers o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g as pr o d uct defects, if a p pr o priate.
g.
Ot her sit u ati o ns:
Me dical or scie ntific j u d g me nt
s h o ul d be e xercise d b y t he i n vesti gat or i n deci di n g 
w het her S A E re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as si g nifica nt 
me dical e ve nts t hat ma y je o par dize t he partici pa nt or ma y  re q uire me dical or 
s ur gical i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve 
defi niti o n.  T hese e ve nts s h o ul d us uall y  be c o nsi dere d seri o us.
E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt 
i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d d yscrasias or 
c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n, or de vel o p me nt of dr u g 
de pe n de nc y  or dr u g a b use.
Pr o gressi o n of t he mali g na nc y  u n der st u dy (i ncl u di n g si g ns a n d sy m pt o ms of 
pr o gressi o n) s h o ul d n ot be re p orte d as a n S A E u nless t he o utc o me is fatal wit hi n 
t he acti ve c ollecti o n peri o d.  H os pitalizati o n d ue t o si g ns a n d s y m pt o ms of 
disease pr o gressi o n s h o ul d n ot be re p orte d as a n S A E.  If t he mali g na nc y  has a 
fatal o utc o me d uri n g t he st u d y, t he e ve nt lea di n g t o deat h m ust be rec or de d as a n 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 5
A E o n t he C R F, a n d as a n S A E wit h C T C A E Gra de 5 (see t he Assess me nt of 
I nte nsity secti o n) if it occ urs d uri n g t he acti ve c ollecti o n peri o d.
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -u p of A Es a n d/ or S A Es D uri n g t he Acti ve 
C ollecti o n Peri o d
A E a n d S A E Rec or di n g/ Re p orti n g
T he ta ble bel o w s u m marizes t he re q uire me nts f or rec or di n g A Es o n t he C R F a n d f or 
re p orti n g S A Es o n C T S A E Re p ort F or m t o Pfizer Safety t hr o u g h o ut t he acti ve c ollecti o n 
peri o d .  T hese re q uire me nts are deli neate d f or 3 ty pes of e ve nts: ( 1) S A Es; ( 2) n o nseri o us 
A Es; a n d ( 3) e x p os ure t o t he s t u d y i nter ve nti o n u n der st u d y d uri n g pre g na nc y or 
breastfee di n g, a n d occ u pati o nal e x p os ure. 
It s h o ul d be n ote d t hat t he C T S A E Re p ort F or m f or re p orti n g S A E i nf or mati o n is n ot t he 
sa me as t he A E pa ge of t he C R F.  W he n t he sa me data is c ollecte d, t he f or ms m ust be 
c o m plete d i n a c o nsiste nt ma n ner.  A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he C T S A E 
Re p ort F or m f or re p orti n g of S A E i nf or mati o n.
S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he C T S A E 
Re p ort F or m t o Pfizer 
S afet y Wit hi n 2 4 H o urs 
of A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y  
i nter ve nti o n u n der st u dy 
d uri n g pre g na nc y  or 
breastfee di n g
All A Es/ S A Es ass ociate d 
wit h E D P or E D B
N ote:   I nsta nces of E D P or 
E D B n ot ass ociate d wit h a n 
A E or S A E are n ot ca pt ure d 
i n t he C R F
All i nsta nces of E D P are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d 
S A E) *
All i nsta nces of E D B are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d S A E) 
* *
E n vir o n me ntal or 
occ u pati o nal e x p os ure t o 
t he pr o d uct u n der st u dy t o 
a n o n-partici pa nt ( n ot 
i n v ol vi n g E D P or E D B)
N o ne.  E x p os ure t o a st u d y  
n o n - partici pa nt is n ot 
c ollecte d o n t he C R F
T he e x p os ure ( w het her or 
n ot t here is a n ass ociate d 
A E or S A E) m ust be 
re p orte d * * *
* E D P ( wit h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer Safet y 
usi n g t he C T S A E Re p ort F or m a n d E D P S u p ple me ntal F or m; if t he E D P is ass ociate d wit h a n S A E, t he n 
t he S A E is re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m. 
* * E D B is re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m, w hic h w o ul d als o i ncl u de details of 
a n y S A E t hat mi g ht be ass ociate d wit h t he E D B. 
* * * E n vir o n me nt al or occ u p ati o n al e x p os ure: A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure are 
re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 6
W he n a n A E/ S A E occ urs, it is t he res p o nsi bilit y  of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic 
re p orts) relate d t o t he e ve nt.
T he i n vesti gat or will t he n rec or d all rele va nt A E/ S A E i nf or mati o n i n t he C R F.
It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer Safet y  i n lie u of c o m pleti o n of t he C T S A E Re p ort 
F or m/ A E/ S A E C R F pa ge.
T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y.  I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he 
me dical rec or ds bef ore s u b missi o n t o Pfizer Safet y.
T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n.  W he ne ver p ossi ble, t he dia g n osis 
( n ot t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E/ S A E.
Assess me nt of I nte nsit y
T he i n vesti g at or will m a ke a n assess me nt of i nte nsit y f or e ac h A E a n d S A E re p orte d 
d uri n g t he st u d y a n d gr a de it acc or di n g t o t he N CI - C T C A E ( Versi o n 5. 0) 
G R A D E
Cli nic al Descri pti o n of Se verit y
1
MI L D a d verse e ve nt
2
M O D E R A T E a d verse e ve nt
3
S E V E R E a d verse e ve nt
4
LI F E -T H R E A T E NI N G c o nse q ue nces; ur ge nt i nter ve nti o n i n dicate d
5
D E A T H R E L A T E D T O a d verse e ve nt
Assess me nt of C a us alit y
T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y i nter ve nti o n 
a n d eac h occ urre nce of eac h A E/ S A E. T he i n vesti gat or will use cli nical 
j u d g me nt t o deter mi ne t he relati o ns hi p.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 7
A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns h i p, rat her t ha n a relati o ns hi p 
ca n n ot be r ule d o ut.
Alter nati ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y 
i nter ve nti o n a d mi nistrati o n, will be c o nsi dere d an d i n vesti gate d.
T he i n vesti gat or will als o c o ns ult t he S R S D(s) a n d/ or pr o d uct i nf or mati o n, f or 
mar kete d pr o d ucts, i n his/ her assess me nt.
F or eac h A E/ S A E, t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat he/s he 
has re vie we d t he A E/ S A E a n d has pr o vi de d a n assess me nt of ca usalit y .
T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or.  H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me n t of c a us alit y 
f or e ver y e ve nt bef ore t he i niti al tr a ns missi o n of t he S A E d at a t o t he 
s p o ns or.
T he i n vesti gat or ma y  c ha n ge his/ her o pi ni o n of ca usalit y i n li g ht of f oll o w- u p 
i nf or mati o n a n d se n d a n S A E f oll o w-u p re p ort wit h t he u p date d ca usalit y  
assess me nt.
T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.
If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he i n vesti gati o nal pr o d uct ca use d 
t he e ve nt, t he n t he e ve nt will be ha n dle d as “relate d to i n vesti gati o nal pr o d uct” 
f or re p orti n g p ur p oses, as defi ne d by t he s p o ns or.  I n a d diti o n, if t he i n vesti gat or 
deter mi nes t hat a n S A E is ass ociate d wit h st u d y  pr oce d ures, t he i n vesti gat or 
m ust rec or d t his ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort 
s uc h a n assess me nt i n t he de dicate d secti o n of t he C T S A E Re p ort F or m a n d i n 
acc or da nce wit h t he S A E re p orti n g re q uire me nts.
F oll o w - u p of A Es a n d S A Es
T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y  i n dicate d or as re q ueste d b y t he 
s p o ns or, t o el uci date t he nat ure a n d/ or ca usality of t he A E or S A E as f ull y as 
p ossi ble.  T his ma y  i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 8
Ne w or u p date d i nf or mati o n will be rec or de d i n t he ori gi nall y  s u b mitte d 
d oc u me nts .
T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs 
of recei pt of t he i nf or mati o n.
1 0. 3. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D at a C ollecti o n T o ol
T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he 
electr o nic data c ollecti o n t o ol.
If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E data 
c ollecti o n t o ol (see ne xt secti o n) i n or der t o re p ort t he e ve nt wit hi n 2 4 h o urs.
T he site will e nter t he S A E data i nt o t he electr o nic s y ste m (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble) as s o o n as t he data bec o mes a vaila ble.
After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic data c ollecti o n t o ol will 
be ta ke n offli ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti n g data.
If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y  re p orte d S A E after t he electr o nic data c ollecti o n t o ol has 
bee n ta ke n offli ne , t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m 
(see ne xt secti o n) or t o Pfizer Safety b y tele p h o ne.
S A E Re p orti n g t o Pfizer S afet y vi a C T S A E Re p ort F or m
Facsi mile tra ns missi o n of t he C T S A E Re p ort F or m is t he preferre d met h o d t o 
tra ns mit t his i nf or mati o n t o Pfizer Safet y.
I n circ u msta nces w he n t he facsi mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d 
be use d, e g, sec ure d ( Tra ns p ort L a yer Sec urit y) or pass w or d-pr otecte d e mail. I f 
n o ne of t hese met h o ds ca n be use d, n otificati o n b y tele p h o ne is acce pta ble wit h a 
c o p y of t he C T S A E Re p ort F or m se nt b y o ver ni g ht mail or c o urier ser vice.
I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he C T S A E Re p ort F or m pa ges wit hi n t he desi g nate d 
re p orti n g ti me fra mes.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 9 9
1 0. 4. A p pe n di x 4: C o ntr ace pti ve G ui d a nce a n d C ollecti o n of Pre g n a nc y I nf or m ati o n
1 0. 4. 1. M ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
Male partici pa nts are eli gi ble t o partici pate if t he y  a gree t o t he f oll o wi n g re q uire me nts d uri n g 
t he i nter ve nti o n peri o d a n d f or at least 5 m o nt hs after t he last d ose of st u dy i nter ve nti o n, 
w hic h c orres p o n ds t o t he ti me nee de d t o eli mi nate st u d y  i nter ve nti o n(s)
Refrai n fr o m d o nati n g s per m.
P L U S eit her :
Be a bsti ne nt fr o m heter ose x ual i nterc o urse wit h a fe male of c hil d beari n g p ote ntial as 
t heir preferre d a n d us ual lifest yle (a bsti ne nt o n a l o n g ter m a n d persiste nt basis) 
a n d a gree t o re mai n a bsti ne nt. 
O R
M ust a gree t o use a male c o n d o m w he n e n ga gi n g i n a n y  acti vit y t hat all o ws f or 
passa ge of ejac ulate t o a n ot her pers o n.
I n a d diti o n t o male c o n d o m use, a hi g hly effecti ve met h o d of c o ntrace pti o n ma y be 
c o nsi dere d i n W O C B P part ners of male partici pa nts (refer t o t he list of hi g hl y  
effecti ve met h o ds bel o w i n Secti o n 1 0. 4. 4 ).
1 0. 4. 2. Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
A fe male partici pa nt is eli gi ble t o partici pate if s he is n ot pre g na nt or breastfee di n g, a n d at 
least 1 of t he f oll o wi n g c o n diti o ns a p plies:
Is n ot a W O C B P (see defi niti o ns bel o w i n Secti o n 1 0. 4. 3 ).
O R
Is a W O C B P a n d usi n g a c o ntrace pti ve met h o d t hat is hi g hl y effecti ve ( wit h a fail ure 
rate of < 1 % per year), prefera bl y wit h l o w user de pe n de nc y , as descri be d bel o w 
d uri n g t he i nter ve nt i o n peri o d a n d f or at least 8 m o nt hs after t he last d ose of st u d y 
i nter ve nti o n, w hic h c orres p o n ds t o t he ti me nee de d t o eli mi nate a n y  st u d y 
i nter ve nti o n(s).  T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he 
c o ntrace pti ve met h o d i n relati o ns hi p t o t he first d ose of st u d y i nter ve nti o n.
T he i n vesti gat or is res p o nsi ble f or re vie w of me dical hist or y , me nstr ual hist or y, a n d rece nt 
se x ual acti vit y t o decrease t he ris k f or i ncl usi o n of a w o ma n wit h a n early u n detecte d 
pre g na nc y .
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 0
1 0. 4. 3.
W o m a n of C hil d be ari n g P ote nti al a n d N o n -C hil d be ari n g P ote nti al
A w o ma n is c o nsi dere d fertile f oll o wi n g me narc he a n d u ntil bec o mi n g p ost me n o pa usal 
u nless per ma ne ntl y sterile (see bel o w).
If fertilit y is u nclear (e g, a me n orr hea i n a d olesce nts or at hletes) a n d a me nstr ual c ycle can n ot 
be c o nfir me d bef ore t he first d ose of st u d y  i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d.
W o me n i n t he f oll o wi n g cate g ories are n ot c o nsi dere d W O C B P:
1.
Pre me narc hal.   
2.
Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g:

D oc u me nte d h ys terect o m y;

D o c u me nte d bilateral sal pi n gect o m y ;

D oc u me nte d bilateral o o p h orect o m y.
F or i n di vi d uals wit h per ma ne nt i nfertilit y  d ue t o a n alter nate me dical ca use ot her t ha n 
t he a b o ve, (e g, m ulleria n a ge nesis, a n dr o ge n i nse nsiti vit y), i n vesti gat or discreti o n 
s h o ul d be a p plie d t o deter mi ni n g st u d y e ntr y.
N ote: D oc u me ntati o n f or a n y  of t he a b o ve cate g ories ca n c o me fr o m t he site 
pers o n nel’s re vie w of t he partici pa nt’s me dical rec or ds, me dical e xa mi nati o n, or 
me dical hist or y  i nter vie w.  T he met h o d of d oc u me ntati o n s h o ul d be rec or de d i n t he 
partici pa nt’s me dical rec or d f or t he st u d y.
3.
P ost me n o pa usal fe male:

A p ost me n o pa usal state is defi ne d as a ge 6 0 ye ars or ol der or n o me nses f or 
1 2 m o nt hs wit h o ut a n alter nati ve me dical ca use. 

A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m a y be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n n ot usi n g h or m o nal c o ntrace pti o n or h or m o ne 
re place me nt t hera py ( H R T). 

Fe males o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o 
use o ne of t he n o nestr o ge n h or m o nal hi g hl y effecti ve c o ntrace pti o n met h o ds 
if t he y wis h t o c o nti n ue t heir H R T d uri n g t he st u d y.  Ot her wise, t he y m ust 
disc o nti n ue H R T t o all o w c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y  
e nr oll me nt.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 1
1 0. 4. 4. C o ntr ace pti o n Met h o ds
C o ntrace pti ve use b y me n or w o me n s h o ul d be c o nsiste nt wit h l ocal a vaila bilit y/re g ulati o ns 
re gar di n g t he use of c o ntrace pti ve met h o ds f or t h ose partici pati n g i n cli nical trials.
T he f oll o wi n g c o ntrace pti ve met h o ds are a p pr o priate f or t his st u d y :
Hi g hl y Effecti ve Met h o ds T h at H a ve L o w User De pe n de nc y
1.
I m pla nta ble pr o gest o ge n o nl y  h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of 
o v ulati o n.
2.
I ntra uteri ne de vice (I U D).
3.
I ntra uteri ne h or m o ne releasi n g sys te m (I U S).
4.
Bilateral t u bal occl usi o n.
5.
Vasect o mize d part ner.

Vasect o mize d part ner is a hi g hl y effecti v e c o ntrace pti ve met h o d pr o vi de d t hat 
t he part ner is t he s ole se x ual part ner of t he W O C B P a n d t he a bse nce of s per m 
has bee n c o nfir me d.  If n ot, a n a d diti o nal hi g hl y effecti ve met h o d of 
c o ntrace pti o n s h o ul d be use d.  T he s per mat o ge nesis c y cle is a p pr o xi matel y 9 0 
da y s.
Hi g hl y Effecti ve Met h o ds T h at Are User De pe n de nt 
1.
C o m bi ne d (estr o ge n a n d pr o gest o ge n c o ntai ni n g) h or m o nal c o ntrace pti o n ass ociate d 
wit h i n hi biti o n of o v ulati o n:

oral;

i ntra va gi nal;

tra ns der mal.
2.
Pr o gest o ge n o nl y h or m o ne c o ntrace pti o n ass ociate d w it h i n hi biti o n of o v ulati o n:

oral;

i njecta ble.
Se x u al a bsti ne nce

Se x ual a bsti ne nce is c o nsi dere d a hi g hl y effecti ve met h o d o nl y  if defi ne d as 
refrai ni n g fr o m heter ose x ual i nterc o urse d uri n g t he e ntire peri o d of ris k ass ociate d 
wit h t he st u d y  i nter ve nti o n.  T he relia bilit y of se x ual a bsti ne nce nee ds t o be 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 2
e val uate d i n relati o n t o t he d urati o n of t he st u dy a n d t he preferre d a n d us ual lifest yle 
of t he partici pa nt.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 3
1 0. 5. A p pe n di x 5 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w- u p Assess me nts 
P ote nti al C ases of Dr u g I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y, b ut a da pt 
are ter me d “a da pt ors.”  I n s o me partici pa nts, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o u tc o me.  T hese partici pa nts fail t o a da pt a n d t heref ore are 
"s usce pti ble" t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as dr u g i n d uce d 
li ver i nj ur y ( DI LI).  Partici pa nts w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 ti mes t he 
× U L N s h o ul d be m o nit ore d m ore fre q ue ntl y  t o deter mi ne if t he y are a n “a da pt or” or are 
“s usce pti ble.”
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de t otal bilir u bi n ( T Bili) 
ele vati o ns ( > 2 × U L N) b y  se veral da ys or wee ks.  T he i ncrease i n T Bili t y picall y occ urs 
w hile A S T/ A L T is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T Bili val ues will be 
ele vate d wit hi n t he sa me la b orat or y  sa m ple).  I n rare i nsta nces, b y t he ti me T Bili ele vati o ns 
are detecte d, A S T/ A L T val ues mi g ht ha ve decrease d.  T his occ urre nce is still re gar de d as a 
p ote ntial DI LI.  T heref ore, a b n or mal ele vati o ns i n eit her A S T O R A L T i n a d diti o n t o T Bili 
t hat meet t he criteria o utli ne d bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y’s la w 
criteria) cases a n d s h o ul d al wa ys be c o nsi de re d i m p orta nt me dical e ve nts, e ve n bef ore all 
ot her p ossi ble ca uses of li ver i nj ur y  ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt’s i n di vi d ual baseli ne val ues a n d u n derl yi n g c o n diti o ns.  Partici pa nts w h o prese nt 
wit h t he f oll o wi n g la b orat or y  a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( Hy’s la w) cases t o defi niti vel y  deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues:
Partici pa nts wit h A S T/ A L T a n d T Bili baseli ne val ue s wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues ≥3 × U L N A N D a T Bili val ue 
≥2 × U L N wit h n o e vi de nce of he m ol ys is a n d a n al kali ne p h os p hatase val ue 
< 2 × U L N or n ot a vaila ble.
F or partici pa nts wit h baseli ne A S T O R A L T O R T Bili val u es a b o ve t he U L N, t he f oll o wi n g 
t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, de pe n di n g o n w hic h 
val ues are a b o ve t he U L N at baseli ne:

Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge: A S T or A L T 
val ues ≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is 
s maller).

Pree xisti n g val ues of T Bili a b o ve t he n or mal ra n ge: T Bili le vel i ncrease d fr o m 
baseli ne val ue b y a n a m o u nt of ≥1 × U L N or if t he val ue reac hes ≥3 × U L N 
( w hic he ver is s maller).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 4
Ri ses i n A S T/ A LT a n d T Bili se parate d b y m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or.  
T he part ici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8 h o urs fr o m a ware ness of t he a b n or mal res ults.  T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p h ysical assess me nt.  
I n a d ditio n t o re peati n g meas ure me nts of A S T a n d A L T a n d T Bili f or s us pecte d cases of 
H y ’s la w, a d diti o nal la b orat or y tests s h o ul d i ncl u de al b u mi n, creati ne ki nase ( C K), direct a n d 
i n direct bilir u bi n, G G T, P T/i nter nati o nal n or malize d rati o (I N R), t otal bile aci ds, a n d al kali ne 
p h os p hatase.  C o nsi derati o n s h o ul d als o be gi ve n t o dra wi n g a se parate t u be of cl otte d bl o o d 
a n d a n a ntic oa g ulate d t u be of bl o o d f or f urt her testi n g, as nee de d, f or f urt her 
c o nte m p ora ne o us a nal ys es at t he ti me of t he rec o g nize d i nitial a b n or malities t o deter mi ne 
eti ol o g y.  A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, s uc h as re vie w of et ha n ol, 
aceta mi n o p he n (eit her b y itself or as a c of or m ulate d pr o d uct i n prescri pti o n or o ver -t he-
c o u nter me dicati o ns), recreati o nal dr u g, s u p ple me nt ( her b al) use a n d c o ns u m pti o n, fa mil y 
hist or y , se x ual hist or y, tra vel hist or y, hist or y of c o ntact wit h a ja u n dice d pers o n, s ur ger y, 
bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d p ote ntial occ u pati o nal e x p os ure t o 
c he micals, s h o ul d be c ollecte d.  F urt her testi n g f or ac ute he patitis A, B, C, D, a n d E i nfecti o n 
a n d li ver i ma gi n g (e g, biliar y tract) a n d c ollecti o n of ser u m sa m ple f or aceta mi n o p he n dr u g 
a n d/ or pr otei n a d d uct le vels ma y  be warra nte d. 
All cases de m o nstrate d o n re peat testi n g as meeti n g t he la b orat or y  criteria of A S T/ A LT a n d 
T Bili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y ’s la w) cases if n o 
ot her reas o n f or t he li ver f u ncti o n test ( L F T) a b n or malities has y et bee n f o u n d.  S uc h 
p ote nti al DI LI ( H y’s l a w) c ases are t o be re p orte d as S A Es, irres pecti ve of a v ail a bilit y 
of all t he res ults of t he i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T 
a b n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nly after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y .
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 5
1 0. 6. A p pe n di x 6 : E C G Fi n di n gs of P ote nti al Cli nic al C o ncer n
E C G Fi n di n gs T h at M a y
Q u alif y as A d verse E ve nts ( A Es)
Mar ke d si n us bra d y car dia (rate < 4 0 b p m) lasti n g mi n utes.
Ne w P R i nter val pr ol o n gati o n > 2 8 0 msec.
Ne w pr ol o n gati o n of Q Tc F t o > 4 8 0 msec (a bs ol ute) or b y 6 0 msec fr o m baseli ne.
Ne w o nset atrial fl utter or fi brillati o n, wit h c o ntr olle d ve ntric ular res p o nse rate: ie, 
rate < 1 2 0 b p m.
Ne w o nset t ype I sec o n d de gree - ( We nc ke bac h) A V bl oc k of > 3 0 sec o n ds’ 
d urati o n.
Fre q ue nt pre mat ure ve ntric ular c o m ple xes ( P V Cs), tri plets, or s h ort i nter vals 
( < 3 0 sec o n ds) of c o nsec uti ve ve ntric ular c o m ple xes.
E C G Fi n di n gs T h at M a y
Q u alif y as Seri o us A d verse E ve nts ( S A Es)
Q Tc F pr ol o n gati o n > 5 0 0 msec.
Ne w S T - T c ha n ges s u g gesti ve of m y ocar dial isc he mia.
Ne w o nset left b u n dle bra nc h bl oc k ( Q R S c o m ple x > 1 2 0 msec).
Ne w o nset ri g ht b u n dle bra nc h bl oc k ( Q R S c o m ple x > 1 2 0 msec).
S y m pt o matic bra d y car dia. 
As y st ole:

I n a wa ke, sy m pt o m free patie nts i n si n us r h y t h m, wit h d oc u me nte d peri o ds of 
as yst ole 3. 0 sec o n ds or a n y  esca pe rate < 4 0 b p m, or wit h a n esca pe r h yt h m 
t hat is bel o w t he A V n o de; 

I n a wa ke, sy m pt o m free patie nts wit h atrial fi brillati o n a n d bra dyc ar dia wit h 
1 or m ore pa uses of at least 5 sec o n ds or l o n g er; 

Atrial fl utter or fi brillati o n, wit h ra pi d ve ntric ular res p o nse rate:
ra pi d = rate 
> 1 2 0 b p m.
S ustai ne d s u pra ve ntric ular tac hyc ar dia (rate > 1 2 0 b p m) (“s ustai ne d” = s h ort 
d urati o n wit h rele va nt s y m pt o ms or lasti n g > 1 mi n ute).
Ve ntric ular r h yt h ms > 3 0 sec o n ds’ d urati o n, i ncl u di n g i di o ve ntric ular r h yt h m ( heart 
rate < 4 0 b p m), accelerate d i di o ve ntric ular r h yt h m ( H R > 4 0 b p m t o < 1 0 0 b p m), 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 6
a n d m o n o m or p hic/ p ol ym or p hic
ve ntric ular tac h yc ar dia ( H R > 1 0 0 b p m [s uc h as 
t orsa des de p oi ntes]).
T yp e II sec o n d de gree ( M o bitz II) A V bl oc k.
C o m plete (t hir d de gree) heart bl oc k.
E C G Fi n di n gs T h at Q u alif y as Seri o us A d verse E ve nts
C ha n ge i n patter n s u g gesti ve of ne w m y ocar dial i nfarcti o n. 
S ustai ne d ve ntric ular tac h y arr h yt h mias ( > 3 0 sec o n ds’ d urati o n).
Sec o n d or t hir d de g ree A V bl oc k re q uiri n g pace ma ker place me nt.
As y st olic pa uses re q uiri n g pace ma ker place me nt.
Atrial fl utter or fi brillati o n wit h ra pi d ve ntric ular res p o nse re q uiri n g car di o versi o n.
Ve ntric ular fi brillati o n/fl utter.
At t he discreti o n of t he i n vesti gat or, a n y arr h yt h mia is classifie d as a n a d verse 
e x perie nce.
T he e n u merate d list of maj or e ve nts of p ote ntial cli nical c o ncer n are rec o m me n de d as “alerts” or 
n otificati o ns fr o m t he c ore E C G la b orat or y t o t he i n vesti gat or a n d Pfizer st u d y tea m, a n d n ot t o be 
c o nsi dere d as all -i ncl usi ve of w hat t o be re p orte d as A Es/ S A Es.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 7
1 0. 7. A p pe n di x 7 . O utc o me Defi niti o ns
T he bel o w o utc o me defi niti o ns will be use d f or re p orti n g of disease assess me nts: 2 1
C o m plete res p o nse ( C R) is defi ne d as a disa p peara nce of le u ke mia as i n dicate d 
b y < 5 % marr o w blasts a n d t he a bse nce of peri p heral bl o o d le u ke mic blasts, wit h 
rec o ver y of he mat o p oiesis defi ne d by A N C ≥1 0 0 0/ µ L  a n d platelets ≥1 0 0, 0 0 0/ µ L.  
C 1 e xtra me d ullar y  disease stat us is re q uire d.
C o m plete res p o nse wit h i nc o m plete c o u nt rec o ver y  ( C Ri) is defi ne d as C R e xce pt 
wit h A N C < 1 0 0 0/ µ L  a n d/ or platelets < 1 0 0, 0 0 0/ µ L.
Partial res p o nse ( P R) is defi ne d as a n i m pr o ve d or n o w orse ni n g of A L L as i n dicate d 
b y  n o peri p heral bl o o d blasts, ne utr o p hils ≥1 0 0 0/ µ L, platelets ≥1 0 0, 0 0 0/ µ L , a n d 
eit her or b ot h of t he f oll o wi n g:

At least a 5 0 % decrease i n t he marr o w blast perce nta ge, c o m pare d t o t he 
pretreat me nt val ue, a n d marr o w blast perce nta ge ≥5 % a n d ≤2 5 %;

C 2 e xtra me d ullar y  disease stat us.
Treat me nt fail ures are defi ne d as patie nts w h o fail t o ac hie ve C R, C Ri or P R will be 
classifie d acc or di n g t o t he t y pe of fail ure:

Resista nt disease: Patie nt s ur vi ves ≥7 da y s f oll o wi n g c o m pleti o n of i nitial 
treat me nt c o urse a n d has persiste nt le u ke mia i n t he m ost rece nt peri p heral bl o o d 
s mear or b o ne marr o w a n d/ or persiste nt disease i n v ol ve me nt at a ny 
e xtra me d ullar y site after c o m pleti o n of t hera p y.

Deat h d uri n g a plasia: Patie nt s ur vi ves ≥7 d a y s f oll o wi n g c o m pleti o n of i nitial 
treat me nt c o urse t he n dies w hile c yt o pe nic, wit h t he last p ost-i n d ucti o n b o ne 
marr o w wit h o ut le u ke mic blasts.
I n deter mi nate:

Patie nt s ur vi ves < 7 da y s after c o m pleti o n of i nitial treat me nt c o urse.

Patie nt s ur vi ves ≥7 da y s f oll o wi n g c o m pleti o n of i nitial treat me nt c o urse t he n 
dies wit h n o persiste nt le u ke mia i n t he peri p heral s mear b ut n o p ost -i n d ucti o n 
b o ne marr o w e xa mi nati o n or e xtra me d ullar y disease e xa mi nati o n.
Rela pse fr o m C R or C Ri:

A p peara nce of le u ke mic blasts i n t he peri p heral bl o o d.

A p peara nce of e xtra me d ullar y  disease.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 8

≥5 % blasts i n t he b o ne marr o w n ot attri b uta ble t o a n ot her ca use (e g, rec o ver y  of 
n or mal cells f oll o wi n g c he m ot hera p y-i n d uce d a plasia).  If t here are n o circ ulati n g 
blasts a n d n o e xtra me d ullar y  disease a n d t he b o ne marr o w blast perce nta ge is
≥5 % b ut < 2 0 %, t he n a re peat b o ne marr o w perf or me d at least 7 da y s after t he first 
marr o w e xa mi nati o n a n d d oc u me nti n g b o ne marr o w blast perce nta ge is 5 % is 
necessar y  t o esta blis h rela pse.
Pr o gressi ve disease is de fi ne d as a d o u bli n g of peri p heral blasts wit h a n a bs ol ute 
i ncrease of > 5 × 1 09/ L a n d/ or a p peara nce of or pr o gressi o n of e xtra me d ullar y 
disease.
T he f oll o wi n g criteria will be use d f or e val uati o n of e xtra me d ullar y  disease:
Meas ura ble e xtra me d ullar y  disease: Lesi o ns t hat ca n be acc uratel y meas ure d i n t w o 
di me nsi o ns b y  C T, M RI, me dical p h ot o gra p h (s ki n or oral lesi o n), or ot her 
c o n ve nti o nal tec h ni q ue a n d a greatest tra ns verse dia meter ( G T D) of 1 c m or 
greater; or pal pa ble lesi o ns wit h b ot h dia meters ≥2 c m.  N o te: alt h o u g h c o m p ute d 
t o m o gra p hy s ca ns re mai n t he sta n dar d f or e val uati o n of n o dal disease, ra di o gra p hic 
sca ns are n ot re q uire d f or patie nts wit h easil y  pal pa ble/s u perficial n o des.
N o n -meas ura ble e xtra me d ullar y  disease: All ot her lesi o ns i ncl u di n g u ni di me nsi o nal 
lesi o ns, lesi o ns t o o s mall t o be c o nsi dere d meas ura ble, ple ural or pericar dial 
eff usi o ns, ascites, b o ne disease, le pt o me ni n geal disease, l y m p ha n gitis, p ul m o nitis, 
a b d o mi nal masses n ot c o nfir me d or f oll o we d b y i ma gi n g tec h ni q ues or disease 
d oc u me nte d b y  i n direct e vi de nce o nly (e g, la b val ues).
E xtra me d ullar y  disease stat us:
C 1: C o m plete disa p peara nce of all meas ura ble a n d n o n- meas ura ble e xtra me d ullar y  
disease wit h t he e xce pti o n of lesi o ns f or w hic h t he f oll o wi n g m ust be tr ue: F or 
patie nts wit h at leas t o ne meas ura ble lesi o n, all n o dal masses > 1. 5 c m i n G T D at 
baseli ne m ust ha ve re gresse d t o ≤1. 5 c m i n G T D a n d all n o dal masses ≥1 c m a n d 
≤1. 5 c m i n G T D at baseli ne m ust ha ve re gresse d t o < 1 c m G T D or t he y  m ust ha ve 
re d uce d by 7 5 % i n s u m of pr o d ucts of gre atest dia meters ( S P D).  N o ne w lesi o ns. 
S plee n a n d ot her pre vi o usl y  e nlar ge d or ga ns m ust ha ve re gresse d i n size a n d m ust 
n ot be pal pa ble.  All diseases m ust be assesse d usi n g t he sa me tec h ni q ue as at 
baseli ne.
C 2: Patie nt d oes n ot q ualif y  f or C 1 stat us.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 9
1 0. 8. A p pe n di x 8 : List of Dr u gs K n o w n t o Pre dis p ose t o T ors a de de P oi ntes
Ge neric N a me
Br a n d N a me(s)
A mi o dar o ne
C or dar o ne ® , Pacer o ne®
Arse nic tri o xi de
Trise n o x ®
Aste miz ole
His ma nal ®
Azit hr o m yci n
Zit hr o ma x ®
Be pri dil
Vasc or ®
C hl or o q ui ne
Arale n ®
C hl or pr o mazi ne
T h orazi ne ®
Cisa pri de
Pr o p ulsi d ®
Cital o pra m
Cele xa ®
Clarit hr o m yci n
Bia xi n ®
Dis o p yra mi de
N or pace ®
D ofetili de
Ti k os y n ®
D o m peri d o ne
M otili u m
®
Dr o peri d ol
I na psi ne®
Er y t hr o m yci n
Er y t hr oci n® , E. E. S.®
Escital o pra m
Le xa pr o ®
Flecai ni de
Ta m b oc or ®
Hal ofa ntri ne
Halfa n ®
Hal o peri d ol
Hal d ol ®
I b utili de
C or vert ®
Le v o met ha d yl
Orlaa m ®
Mes ori dazi ne
Sere ntil ®
Met ha d o ne
D ol o p hi ne ® , Met ha d ose®
M o xifl o xaci n
A vel o x ®
O n de nsetr o n *
Z ofra n ®
Pe nta mi di ne
Pe nta m ® , Ne b u Pe nt®
Pi m ozi de
Ora p ®
Pr o b uc ol
L orelc o ®
Pr ocai na mi de
Pr o nest yl ® , Pr oca n®
Q ui ni di ne
Car di o q ui n ® , Q ui na gl ute®
Se v ofl ura ne
Ula ne ® , S oj o ur n ®
S otal ol
Beta pace ®
S parfl o xaci n
Za ga m ®
Terfe na di ne
Sel da ne ®
T hi ori dazi ne
Mellaril
®
Va n deta ni b
Zacti ma ®
Refere nce: " T orsa des List: Dr u gs wit h a Ris k of T orsa des de P oi ntes," dr u gs t hat are ge nerall y acce pte d b y t he 
Q T dr u gs. or g A d vis or y B oar d t o carr y a ris k of T orsa des de P oi ntes o n t he U ni versit y of Ariz o na C E R T 
we bsite: htt p://cre di ble me ds. or g/e ver y o ne/c o m p osite -list-all -qt dr u gs.  See we bsite f or c urre nt list a n d refer t o 
t he rele va nt pac ka ge i nsert.
* Z ofra n: i ntra ve n o us (I V) d ose > 1 6 m g (refere nce, 2 9J u n 2 0 1 2 U S F D A Dr u g Safet y C o m m u nicati o n; U S F D A 
we bsite htt p:// w w w.f da. g o v/ Dr u gs/ Dr u g Safet y/ uc m 3 1 0 1 9 0. ht m).
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 0
1 0. 9. A p pe n di x 9 . E aster n C o o per ati ve O nc ol o g y Gr o u p ( E C O G) Perf or m a nce St at us
E C O G
Gr a de
Descri pti o n
0
F ull y acti ve, a ble t o c arr y o n all pre dise ase perf or m a nce wit h o ut 
restricti o n
1
Restricte d i n p h ysic all y stre n u o us acti vit y, b ut a m b ul at or y a n d a ble t o 
c arr y o ut w or k of a li g ht or se de nt ar y n at ure, ie li g ht h o use w or k , office 
w or k.
2
A m b ul at or y a n d c a p a ble of all self -c are b ut u n a ble t o c arr y o ut a n y 
w or k acti vities.  U p a n d a b o ut m ore t h a n 5 0 % of w a ki n g h o urs
3
C a p a ble of o nl y li mite d self -c are, c o nfi ne d t o be d or c h air m ore t h a n 
5 0 % of w a ki n g h o urs.
4
C o m pletel y dis a ble d.  C a n n ot c arr y o n a n y self-c are. T ot all y 
c o nfi ne d t o be d or c h air.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 1
1 0. 1 0. A p pe n di x 1 0 . Rec o m me n d ati o n f or P atie nts Pr ocee di n g t o Tr a ns pl a nt a n d 
P ote nti al V O D C ases

F or patie nts pla n ni n g t o recei ve H S C T, it is rec o m me n de d t hat treat me nt wit h 
i n ot uz u ma b oz o ga mici n be li mite d t o 2 c ycles; a t hir d c ycle ma y be gi ve n f or patie nts 
n ot ac hie vi n g C R/ C Ri wit h M R D ne gat i vity after 2 c ycles.  

T he ris k of rela pse m ust be bala nce d a gai nst t he p ote ntial ris k of t o xicit y  ass ociate d 
wit h be gi n ni n g H S C T s o o n after t he last d ose of i n ot uz u ma b oz o ga mici n.  I n P hase 3 
St u d y  B 1 9 3 1 0 2 2, t he me dia n ti me bet wee n last d ose of i n ot uz u mab oz o ga mici n a n d 
H S C T f or patie nts pr ocee di n g directl y t o H S C T was 4. 9 wee ks (ra n ge: 1 - 1 9 wee ks).

Healt hcare pr o vi ders s h o ul d use t heir cli nical j u d g me nt t o deter mi ne t he m ost 
a p pr o priate c o urse of t hera p y f or pr o p h yl actic treat me nt of V O D bef ore t he star t of 
c o n diti o ni n g t hera p y acc or di n g t o sta n dar d of care (e g, pr o p h yl actic urs o de o x yc h olic 
aci d* [ pr o prietar y na mes i ncl u de Acti gall, Urs o, a n d Urs o di ol] at 
1 2 - 1 5 m g/ k g/ da y ), be gi n ni n g 2 wee ks bef ore t he start of c o n diti o ni n g t hera p y.2 2 ,2 3

Use t he least he pat ot o xic c o n diti o ni n g re gi me n a n d, s pecificall y, a v oi d usi n g re gi me ns 
t hat c o ntai n 2 al kyl ati n g a ge nts a n d or t hat c o m bi ne a n al k yl ati n g a ge nt wit h hi g her 
d ose t otal b o d y  irra diati o n ( T BI) ( defi ne d as > 1 2 G y). 

If usi n g a b us ulfa n c o ntai ni n g c o n diti o ni n g re gi me n, please c o nsi der usi n g 
p har mac o ki neticall y  d ose d b us ulfa n.2 4

W he n p ossi ble, a v oi d t he c o nc o mita nt use of he pat ot o xic dr u gs peri tra ns pla nt.

If si g nifica nt li ver t o xicit y occ urs, c o ns ult a gastr oe nter ol o g y a n d/ or he pat ol o g y 
ser vice.

W he n e val uati n g li ver t o xicit y , i nf or m t he ra di ol o gist of t he p ote ntial f or he patic 
vasc ular disease.  W he n V O D is i n t he differe ntial dia g n osis, a ri g ht u p per q ua dr a nt 
ultras o u n d wit h c ol or fl o w d o p pler (i ncl u di n g resisti ve i n dices t o he patic arter y  fl o w 
a n d e val uati o n of he patic ve n o us o utfl o w) s h o ul d be perf or me d.  I n a d diti o n, t he 
ra di ol o g y re p ort s h o ul d descri be t he de gree of gall bla d der wall t hic ke ni n g i n 
milli meters a n d t he v ol u me of ascites s h o ul d be esti mate d as cl osel y as p ossi ble (ie, 
s mall a n d l ocalize d, m o derate a n d ge neralize d, or lar ge a n d ge neralize d).

Defi br oti de * * m a y  be use d i n t he setti n g of se vere V O D.2 5  I n P hase 3 St u d y 
B 1 9 3 1 0 2 2, 4/ 8 i n ot uz u ma b oz o ga mici n treate d patie nts w h o ha d Gra de 3 or 4 V O D 
after a f oll o w u p H S C T a n d w h o were treate d wit h defi br oti de r ec o vere d.  T he me dia n 
d urati o n of defi br oti de treat me nt was 2 0 da y s.  Of n ote, i n ot uz u ma b oz o ga mici n 
treate d patie nts wit h Gra de 3 or 4 V O D after a f oll o w u p H S C T a n d n ot treate d wit h 
defi br oti de di d n ot rec o ver.

If a patie nt will pr ocee d t o H S C T u n der t he care of differe nt p h ysicia ns, t his
rec o m me n dati o n s h o ul d be re vie we d wit h t he ne w treati n g p hys icia ns.
* Urs o de o x yc h olic aci d is a ut h orize d f or use b y re g ulat or y  a ut h orities i n C hi na.
* * Defi br oti de is n ot a ut h orize d f or use i n C hi na.  
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 2
1 0. 1 1. A p pe n di x 1 1. Alter n ati ve Me as ures D uri n g P u blic E mer ge ncies
T he alter nati ve st u d y  meas ures descri be d i n t his secti o n are t o be f oll o we d d uri n g p u blic 
e mer ge ncies, i ncl u di n g t he C O VI D - 1 9 pa n de mic. T his secti o n a p plies f or t he d urati o n of t he 
C O VI D -1 9 pa n de mic i n C hi na a n d will bec o me effecti ve f or ot her p u blic e mer ge ncies o nl y 
u p o n writte n n otificati o n fr o m Pfizer.
Use of t hese alter nati ve st u d y  meas ures are e x pecte d t o cease u p o n t he ret ur n of b usi ness-as-
us ual circ u msta nces (i ncl u di n g t he lifti n g of a n y q uara nti nes a n d tra vel ba ns/a d vis ories).
1 0. 1 1. 1. Eli gi bilit y
W hile C O VI D - 1 9/S A R S -C o V -2 testi n g is n ot ma n date d f or e ntr y  i nt o t his st u d y, testi n g 
s h o ul d f oll o w l ocal cli nical practice sta n dar ds. If a partici pa nt has a p ositi ve test res ult f or 
C O VI D - 1 9/S A R S -C o V -2 i nfecti o n wit hi n 1 4 da y s pri or t o e nr oll me nt, is k n o w n t o ha ve 
as ym pt o matic i nfecti o n or is s us pecte d of ha vi n g C O VI D - 1 9/S A R S -C o V -2, t he y  are 
e xcl u de d.
1 0. 1 1. 2. Tele he alt h Visits
I n t he e ve nt t hat i n-cli nic st u d y visits ca n n ot be c o n d ucte d, e ver y eff ort s h o ul d be ma de t o 
f oll o w- u p o n t he safet y  of st u d y partici pa nts at sc he d ule d visits per t he S o A or u nsc he d ule d 
visits. Tele healt h visits ma y  be use d t o c o nti n ue t o assess partici pa nt safety a n d c ollect data 
p oi nts. Tele healt h i ncl u des t he e x c ha n ge of healt hcare i nf or mati o n a n d ser vices via 
telec o m m u nicati o n tec h n ol o gies (e g, a u di o, vi de o, vi de o-c o nfere nci n g s oft ware) re m otel y, 
all o wi n g t he partici pa nt a n d t he i n vesti gat or t o c o m m u nicate o n as pects of cli nical care, 
i ncl u di n g me dical a d vice, re mi n ders, e d ucati o n, a n d safet y m o nit ori n g. T he f oll o wi n g 
assess me nts ma y be perf or me d d uri n g a tele healt h visit:
Re vie w a n d rec or d a n y A Es a n d S A Es si nce t he last c o ntact. Refer t o st u d y pr ot oc ol 
Secti o n 8. 4 .
Re vie w a n d rec or d a n y ne w c o nc o mita nt me dicati o ns or c ha n ges i n c o nc o mita nt 
me dicati o ns si nce t he last c o ntact.
Re vie w a n d rec or d c o ntrace pti ve met h o d a n d res ults of pre g na nc y  testi n g. C o nfir m t hat 
t he partici pa nt is a d heri n g t o t he c o ntrace pti o n met ho d(s) re q uire d i n t he pr ot oc ol.
St u d y  partici pa nts m ust be re mi n de d t o pr o m ptly n otif y  site staff a b o ut a ny c ha n ge i n t heir 
healt h stat us.
1 0. 1 1. 3. Alter n ati ve F acilities f or S afet y Assess me nts
1 0. 1 1. 3. 1. L a b or at or y Testi n g
If a st u dy partici pa nt is u na ble t o visit t he site f or pr ot oc ol -s pecifie d safet y la b orat or y 
e val uati o ns, testi n g ma y be c o n d ucte d at a l ocal la b orat or y if per mitte d b y l ocal re g ulati o ns. 
T he l ocal la b orat or y  ma y be a sta n dal o ne i nstit uti o n or wit hi n a h os pital. T he safety 
la b orat or y e val uati o ns ma y be perf or me d at a l ocal la b orat or y, i ncl u di n g pre g na nc y testi n g.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 3
If a l ocal la b orat or y is use d, q ualifie d st u d y site pers o n nel m ust or der, recei ve, a n d re vie w 
res ults. Site staff m ust c ollect t he l ocal la b orat or y refere nce ra n ges a n d 
certificati o ns/accre ditati o ns f or fili n g at t he site. La b orat or y test res ults are t o be pr o vi de d t o 
t he site staff as s o o n as p ossi ble. T he l ocal la b orat or y re p orts s h o ul d be file d i n t he 
partici pa nt’s s o urce d oc u me nts/ me dical rec or ds. Rele va nt data fr o m t he l ocal la b orat or y  
re p ort s h oul d be rec or de d o n t he C R F.
If a partici pa nt re q uiri n g pre g na nc y testi n g ca n n ot visit a l ocal la b orat or y f or pre g na nc y 
testi n g, a h o me uri ne pre g na nc y testi n g kit wit h a se nsiti vit y of at least 2 5 mIU/ m L ma y  be 
use d b y  t he partici pa nt t o perf or m t he test at h o me, if c o m plia nt wit h l ocal re g ulat or y 
re q uire me nts. T he pre g na nc y test o utc o me s h o ul d be d oc u me nte d i n t he partici pa nt’s s o urce 
d oc u me nts/ me dical rec or ds a n d rele va nt data rec or de d o n t he C R F. C o nfir m t hat t he 
partici pa nt is a d heri n g t o t he c o ntrace pt i o n met h o d(s) re q uire d i n t he pr ot oc ol.
1 0. 1 1. 3. 2. I m a gi n g
If t he partici pa nt is u na ble t o visit t he st u d y site f or C T sca ns or M RI, t he partici pa nt ma y 
visit a n alter nati ve facilit y  t o ha ve t he C T sca ns, M RI, or w h ole b o d y b o ne sca n perf or me d, 
after disc ussi o n wit h t he s p o ns or. Q ualifie d st u d y  site pers o n nel m ust or der, recei ve, a n d 
re vie w res ults.
1 0. 1 1. 3. 3. Electr oc ar di o gr a ms
If t he partici pa nt is u na ble t o visit t he st u d y site f or E C Gs, t he partici pa nt ma y visit a n 
alter nati ve facilit y t o ha ve t he E C Gs perf or me d. Q ualifie d stu d y  site pers o n nel m ust or der, 
recei ve, a n d re vie w res ults. T he E C G ma y be re peate d if lea d place me nts are re verse d or 
i nc orrect.
1 0. 1 1. 4. St u d y I nter ve nti o n
If t he safety of a trial partici pa nt is at ris k beca use t he y ca n n ot c o m plete re q uire d e val uati o ns 
or a d here t o critical miti gati o n ste ps, t he n disc o nti n ui n g t hat partici pa nt fr o m st u d y 
i nter ve nti o n m ust be c o nsi dere d.
T he f oll o wi n g is rec o m me n de d f or t he a d mi nistrati o n of st u d y  i nter ve nti o n f or partici pa nts 
w h o ha ve acti ve c o nfir me d ( p ositi ve b y  re g ulat or y a ut h ority- a p pr o ve d test) or pres u me d (test 
pe n di n g/cli nical s us pici o n) C O VI D - 1 9/S A R S -C o V -2 i nfecti o n:

F or s y m pt o mat ic partici pa nts wit h acti ve C O VI D - 1 9/S A R S -C o V -2 i nfecti o n, st u d y  
i nter ve nti o n s h o ul d be dela ye d f or at least 1 4 da ys fr o m t he start of sy m pt o ms. T his dela y  
is i nte n de d t o all o w t he res ol uti o n of s ym pt o ms of C O VI D - 1 9/S A R S -C o V -2 i nfecti o n.

Pri or t o restarti n g treat me nt, t he partici pa nt s h o ul d be afe brile f or 7 2 h o urs, a n d C O VI D -
1 9/ S A R S -C o V - 2 -relate d s ym pt o ms s h o ul d ha ve rec o vere d t o ≤Gra de 1 f or a mi ni m u m 
of 7 2 h o urs. N otif y  t he st u d y tea m w he n treat me nt is restarte d.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 4

C o nti n ue t o c o nsi der p ote ntial dr u g -dr u g i nteracti o ns as descri be d i n st u d y pr ot oc ol 
Secti o n 6. 9 f or a ny c o nc o mita nt me dicati o n a d mi nistere d f or treat me nt of C O VI D -
1 9/ S A R S -C o V -2 i nfecti o n.
1 0. 1 1. 5. H o me He alt h Visits
A h o me healt h care ser vice m a y be utilize d t o facilitate sc he d ule d visits per t he S o A . H o me 
healt h visits i ncl u de a healt hcare pr o vi der c o n d ucti n g a n i n- pers o n st u d y  visit at t he 
partici pa nt’s l ocati o n, rat her t ha n a n i n -pers o n st u d y  visit at t he site. T he f oll o wi n g ma y be 
perf or me d d uri n g a h o me healt h visit, if per mitte d b y l ocal re g ulati o ns:

All safet y assess me nts

Re q uire d bl o o d sa m ples
1 0. 1 1. 6. A d verse E ve nts a n d Seri o us A d verse E ve nts
If a partici pa nt has C O VI D-1 9 d uri n g t he st u d y , t his s h o ul d be re p orte d as a n A E or S A E a n d 
a p pr o priate me dical i nter ve nti o n pr o vi de d. Te m p orar y  disc o nti n uati o n of t he st u d y 
i nter ve nti o n ma y be me dicall y a p pr o priate u ntil t he partici pa nt has rec o vere d fr o m 
C O VI D - 1 9.
It is rec o m me n de d t hat t he i n vesti gat or disc uss te m porar y  or per ma ne nt disc o nti n uati o n of 
st u d y i nter ve nti o n wit h t he me dical m o nit or.
1 0. 1 1. 7. C O VI D -1 9 V acci nes
C O VI D -1 9 vacci nes (a p pr o ve d or gi ve n b y  e mer ge nc y use a ut h orizati o n) are per mitte d a n d 
s h o ul d be rec or de d i n t he C R F. T he ti mi n g of vacci ne a d mi nistrati o n relati ve t o st u d y 
i nter ve nti o n is at t he discreti o n of t he i n vesti gat or alt h o u g h, if p ossi ble, it is best t o a v oi d 
vacci ne a d mi nistrati o n d uri n g t he st u d y i nter ve nti o n peri o d. C O VI D -1 9 vacci nes recei ve d 
pri or t o st u d y  e nr oll me nt a n d d uri n g st u d y partici pati o n will be c ollecte d i n t he C R F.
1 0. 1 1. 8. C O VI D -1 9 I nfecti o n
Partici pa nts wit h A L L are at i ncrease d ris k of se vere disease a n d c o m plicati o ns fr o m 
C O VI D - 1 9 i nfecti o n ( C hari et al, 2 0 2 0; Ter p os et al, 2 0 2 0). Partici pa nts s h o ul d be re g ularly 
e d ucate d o n t he c o nti n ui n g ris k a n d s y m pt o ms of C O VI D -1 9 i nfecti o n, best practices t o 
re d uce t he ris k of i nfecti o n i ncl u di n g mas k usa ge, a n d t he i m p orta nce of re g ular testi n g 
i ncl u di n g at h o me. Partici pa nts are t o be teste d f or C O VI D-1 9 u p o n e x p os ure t o C O VI D - 1 9 
a n d at si g ns or s ym pt o ms of C O VI D -1 9 i nfecti o n (e g. ne w or w orse ni n g fe ver, c o u g h, s ore 
t hr oat, s h ort ness of breat h or fati g ue). Fre q ue nt refle x testi n g is e nc o ura ge d. A p ositi ve 
C O VI D -1 9 test res ult s h o ul d be i m me diatel y  re p orte d t o t he st u d y i n vesti gat or a n d 
d oc u me nte d as a n A E.
Partici pa nts w h o de vel o p C O VI D -1 9 i nfecti o n w hile o n st u d y  s h o ul d be ma na ge d i n 
acc or da nce wit h t heir treati n g healt hcare pr o vi der’s sta n dar d of care a n d l ocal a n d/ or re gi o nal 
g ui deli nes, c o nsi deri n g all treat me nts a vaila ble t o st u d y  partici pa nts, i ncl u di n g 
P A X L O VI D ™ a n d m o n ocl o nal a nti b o d y  treat me nts. In acc or da nce wit h sta n dar d of care 
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 5
practice, it is e x pecte d t hat i nitiati o n of treat me nt will start as s o o n as p ossi ble a n d i deall y 
wit hi n 2 4 h o urs f oll o wi n g a p ositi ve C O VI D- 1 9 test. W here feasi ble, t he s p o ns or will s u p pl y 
P A X L O VI D ™ t hat ma y  be use d f or treat me nt of C O VI D- 1 9 i n acc or da nce wit h prescri bi n g 
i nf or mati o n.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 6
1 0. 1 2. A p pe n di x 1 2. Ki d ne y S afet y: M o nit ori n g G ui deli nes 
1 0. 1 2. 1. L a b or at or y Assess me nt of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y
Sta n dar d ki d ne y  safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost baseli ne ( Scr 
meas ure me nt t o e G F R [ Scr- base d e G F R]) or e Cr Cl. Baseli ne a n d p ost baseli ne Sc y s ma kes it 
feasi ble t o disti n g uis h A KI fr o m ot her ca uses of Scr i ncrease. If Scr i ncrease is c o nfir me d 
after baseli ne, t he n refle x meas ure me nt of Sc y s is i n dicate d t o esti mate t he c o m bi ne d Scr-
Sc y s e G F R calc ulati o n (f or a d ults o nl y).
Re gar dless of w het her ki d ne y  f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safety 
m o nit ori n g pr oce d ure i n t he st u d y, if t he i n vesti gat or or s p o ns or dee ms it necessar y t o f urt her 
assess ki d ne y safet y a n d q ua ntif y ki d ne y f u ncti o n, t he n t hese test res ults s h o ul d be ma na ge d 
a n d f oll o we d per sta n dar d of care.
1 0. 1 2. 2. A ge - S pecific Ki d ne y F u ncti o n C alc ul ati o n Rec o m me n d ati o ns
1 0. 1 2. 2. 1. A d ults ( 1 8 Ye ars a n d A b o ve) — 2 0 2 1 C K D- E P I E q u ati o ns
2 0 2 1 
C K D -E PI 
Scr o nl y
Scr
( m g/ d L)
Sc ys
( m g/ L)
Rec o m me n de d e G F R E q u ati o n
Fe male
if ≤ 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) - 0. 2 4 1  × ( 0. 9 9 3 8) A ge
Fe male
if > 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) - 1. 2 0 0  × ( 0. 9 9 3 8) A ge
Male
if ≤ 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) - 0. 3 0 2  × ( 0. 9 9 3 8) A ge
Male
if > 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) - 1. 2 0 0  × ( 0. 9 9 3 8) A ge
2 0 2 1 
C K D -E PI 
Scr- Sc ys 
C o m bi ne d
Scr
( m g/ d L)
Sc ys
( m g/ L)
Rec o m me n de d e G F R E q u ati o n
Fe male
if ≤ 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7)- 0. 2 1 9  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Fe male
if ≤ 0. 7
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 2 1 9  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Fe male
if > 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Fe male
if > 0. 7
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) - 0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Male
if ≤ 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 1 4 4  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Male
if ≤ 0. 9
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 1 4 4  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Male
if > 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 5 4 4  ×  ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Male
if > 0. 9
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) - 0. 5 4 4  ×  ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
I n ker L A et al. N E n gl J Me d. 2 0 2 1; 3 8 5: 1 7 3 7-4 9. 
1 0. 1 2. 3. A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y A b n or m alities
A E gra di n g f or decli ne i n ki d ne y  f u ncti o n (ie, e G F R or e Cr Cl) will be acc or di n g t o C T C A E 
criteria.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 7
1 0. 1 3. A p pe n di x 1 3. Pr ot oc ol A me n d me nt Hist or y
T he pr ot oc ol a me n d me nt s u m mar y  of c ha n ges ta ble f or t he c urre nt a me n d me nt is l ocate d 
directl y  bef ore t he T O C. T he pr ot oc ol a me n d me nt s u m mar y of c ha n ges ta bles f or past 
a me n d me nt(s) ca n be f o u n d bel o w:
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
D oc u me nt Hist or y
D oc u me nt  
Versi o n D ate
S u m m ar y of C h a n ges a n d R ati o n ale
Ori gi nal pr ot oc ol
2 Dece m ber 2 0 1 9
N ot a p plica ble ( N/ A)
A me n d me nt 1
3 Marc h 2 0 2 2
T his a me n d me nt is ma ki n g t he f oll o wi n g 
c ha n ges t o t he ori gi nal pr ot oc ol:
a)
Re m o ve t he descri pti o n of I V R S/I W R S i n 
Secti o n 5. 4. Scree n Fail ures.
b)
Re m o ve t he descri pti o n of I R T i n Secti o n 
6. 3. 1. All ocati o n t o I n vesti gati o nal 
Pr o d uct.
c)
Re m o ve t he descri pti o n of b o ne marr o w 
as pirate i n Secti o n 8. 5. 1.
d)
U p date d bi o mar ker testi n g assa y  i n Secti o n 
8. 8 a n d t hr o u g h o ut.
e)
U p date d t he defi niti o n of sec o n dar y  
e n d p oi nt of M R D ne gati vit y i n patie nts 
ac hie vi n g C R/ C Ri.
f)
Clarificati o ns were ma de t hr o u g h o ut, 
i ncl u di n g t he S o A.
g)
T he d osi n g re gi me n f or i n ot uz u ma b 
oz o ga mici n i n t his st u d y  has bee n u p date d 
t o be t he sa me as t hat use d i n t he N M P A-
a p pr o ve d la beli n g t o ali g n wit h C hi na l ocal 
a p pr o val la beli n g.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 8
1 0. 1 4. A p pe n di x 1 4: A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y  be use d i n t he pr ot oc ol.
A b bre vi ati o n
Ter m
Ac B ut
b uta n oic aci d
A D A
a nti-dr u g a nti b o dies
A D C
a nti b o d y dr u g c o nj u gate
A E
a d verse e ve nt
A L L
ac ute l y m p h o blastic le u ke mia
A L T
ala ni ne a mi n otra nsferase
A N C
a bs ol ute ne utr o p hil c o u nt
A P T T
acti vate d partial t hr o m b o plasti n ti me
Ara -C
c yt osi ne ara bi n osi de
A S H
alc o h olic steat o he patitis
A S T
as partate a mi n otra nsferase
A V
atri o ve ntric ular
B -A L L
B -li nea ge A L L
B C R P
breast ca ncer resista nce pr otei n
-H C G
beta -h u ma n c h ori o nic g o na d otr o pi n 
B M
b o ne marr o w
B M A
b o ne marr o w as pirate
b p m
beats per mi n ute
B S A
b o d y  s urface area
B U N
bl o o d urea nitr o ge n
c A U C p 1
i n ot uz u ma b oz o ga mici n c u m ulati ve t otal ser u m e x p os ure d uri n g 
C y cle 1
C a v g
a vera ge ser u m c o nce ntrati o n u p t o t he ti me of res p o nse
C B C
c o m plete bl o o d c o u nt
C D
cl uster of differe ntiati o n
C D E
C hi na Ce nter f or Dr u g E val uati o n
C F R
C o de of Fe deral Re g ulati o ns
CI
c o nfi de nce i nter val
CI O M S
C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical Scie nces
C K
creati ne ki nase
C K D -E PI
c hr o nic ki d ne y disease e pi de mi ol o g y 
C ma x
ma xi m u m o bser ve d c o nce ntrati o n
C N S
ce ntral ner v o us s ys te m
C O N S O R T
C o ns oli date d Sta n dar ds of Re p orti n g Trials
C O VI D -1 9
c or o na vir us disease 2 0 1 9
C R
c o mplete re missi o n
C R F
case re p ort f or m
C Ri
i nc o m plete he mat ol o gic rec o ver y
C R p
C R wit h i nc o m plete platelet rec o ver y
C S F
cere br os pi nal fl ui d
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 9
A b bre vi ati o n
Ter m
C S X R T
cra ni os pi nal ra diati o n
C T
c o m p ute d t o m o gra p h y
C T C A E
C o m m o n Ter mi n ol o g y  Criteria f or A d verse E ve nts
C tr o u g h
tr o u g h plas ma c o nce ntrati o n
C T W
Cli nical Trial Wai ver
C V
c oefficie nt of variati o n
D F S
disease -free s ur vi val
DI LI
dr u g i n d uce d li ver i nj ur y
D M C
data m o nit ori n g c o m mittee
D N A
de o x yri b o n ucleic aci d
D o R
d urati o n of re missi o n
E A C
e n d p oi nt a dj u dicati o n c o m mittee
E C
et hics c o m mittee
E C G
Electr ocar di o gra m
E C H O
ec h ocar di o gra m
E C O G
Easter n C o o perati ve O nc ol o g y  Gr o u p
e C R F
electr o nic case re p ort f or m
E D P
e x p os ure d uri n g pre g na nc y
E O T
E n d -of -treat me nt
E U
E ur o pea n U ni o n
E u dra C T
E ur o pea n Cli nical Trials Data base
F A C S
fl u oresce nce-acti vate d cell s orter
F D A
F o o d a n d Dr u g A d mi nistrati o n
FI S H
fl u oresce nce i n sit u h y bri dizati o n
F L A G
fl u dara bi ne + c ytara bi ne + gra n ul oc yte c ol o n y sti m ulati n g fact or
F S H
f ollicle sti m ulati n g h or m o ne
G C P
G o o d Cli nical Practice
G -C S F
gra n ul oc y te-c ol o n y sti m ulati n g fact or
G G T
ga m ma gl uta m yl  tra nsferase
G M -C S F
macr o p ha ge -c ol o n y sti m ulati n g fact or
G T D
greatest tra ns verse dia meter
G v H D
graft v ers us h ost disease 
H bs A g 
he patitis B s urface a nti ge n 
H C V
he patitis C vir us
H E A C
He patic E ve nts A dj u dicati o n C o m mittee
H G R A C
H u ma n Ge netic Res o urce A d mi nistrati o n of C hi na
HI D A C
hi g h d ose c y tara bi ne
HI P A A
Healt h I ns ura nce P orta bilit y  a n d Acc o u nta bilit y Act
HI V
h u ma n i m m u n o deficie nc y vir us
H R
hazar d rati o
H R T
h or m o ne re place me nt t hera p y
H S C T
he mat o p oietic ste m cell tra ns pla nt
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 0
A b bre vi ati o n
Ter m
H y per -C V A D
h y per c ycl o p h os p ha mi de, vi ncristi ne, a dria m yci n, a n d 
de xa met has o ne
I B
i n vesti gat or’s br oc h ure
I C D
i nf or me d c o nse nt d oc u me nt
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n
I g G 4
i m m u n o gl o b uli n class G s u bt ype 4
I g H
i m m u n o gl o b uli n hea vy c hai n
I g K
i m m u n o gl o b uli n ka p pa li g ht c hai n
I gL
i m m u n o gl o b uli n la m b da li g ht c hai n
I H C
i m m u n o hist oc he mistr y
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
i n vesti gati o nal ne w dr u g a p plicati o n
I N R
i nter nati o nal n or malize d rati o
IP A L
I n vesti gati o nal Pr o d uct Acc o u nta bilit y L o g
I P ma n ual
i n vesti gati o nal pr o d uct ma n ual
IP M
i n vesti gati o nal pr o d uct ma n ual
I RB
i nstit uti o nal re vie w b oar d
I T T
i nte nt-t o-treat
I UD
i ntra uteri ne de vice
I U S
i ntra uteri ne h or m o ne releasi n g sys te m
I V
i ntra ve n o us
I V R S
I nteracti ve V oice Res p o nse S yste m
I W R S
I nteracti ve We b Res p o nse S yste m
L D H
lactate de hy d r o ge nase
L F T
li ver f u ncti o n test
L V E F
left ve ntric ular ejecti o n fracti o n
Me d D R A
Me dical Dicti o nar y  f or Re g ulat or y Acti vities
M O F
m ulti or ga n fail ure
msec
m illisec o n d
M R D
mi ni mal resi d ual disease
M U G A
M ulti gate d Ac q uisiti o n Sca n
M X N 
mit o xa ntr o ne
N/ A
n ot a p plica ble
N A b
ne utralizi n g a nti b o dies
N A F L
n o n -alc o h olic fatt y li ver
N A S H
n o n -alc o h olic steat o he patitis
N CI
Nati o nal Ca ncer I nstit ute
N D A
ne w dr u g a p plicati o n
N G S
ne xt ge nerati o n se q ue nci n g
N H L
n o n -H o d g ki n’s l y m p h o ma
NI M P
N o n i n vesti gati o nal me dici nal pr o d uct
N M P A
Nati o nal Me dical Pr o d ucts A d mi nistrati o n
N R M
n o n -rela pse m ortalit y
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 1
A b bre vi ati o n
Ter m
N Y H A
Ne w Y or k Heart Ass ociati o n
O A T
or ga nic a ni o n tra ns p orter
O A T P
or ga nic a ni o n tra ns p orti n g p ol y pe pti de
O C T
or ga nic cati o n tra ns p orter
O S
o verall s ur vi val
P A C
p ost a p pr o val c o m mit me nt
P D
p har mac o d y n a mic(s)
P E
p h y sical e xa mi nati o n
P F S
pr o gressi o n free s ur vi val
P h +
P hila del p hia c hr o m os o me p ositi ve
P h -
P hila del p hia c hr o m os o me ne gati ve
P K
p har mac o ki netic(s)
P R
partial res p o nse
P S
perf or ma nce stat us
P T
pr ot hr o m bi n ti me
P T T
partial t hr o m b o plasti n ti me
P V C
pre mat ure ve ntric ular c o ntracti o n/c o m ple x
Q Tc
c orrecte d Q T
Q Tc F
c orrecte d Q T ( Fri dericia met h o d)
Q Tc S
Q T i nter val c orrecte d f or heart rate usi n g a p o p ulati o n s pecific 
met h o d
R P 2 D
rec o m me n de d P hase 2 d ose
S A E
seri o us a d verse e ve nt
S A P
statistical a nal ysis pla n
S A R S -C o V -2
se vere ac ute res pirat or y s yn dr o me c or o na vir us 2
Scr
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S o A
sc he d ule of acti vities
S O P
sta n dar d o perati n g pr oce d ure
S O S
si n us oi dal o bstr ucti o n s y n dr o me
S P D
s u m of pr o d ucts of greatest dia meters
S R S D
si n gle refere nce safety d oc u me nt
S T o D
st u d y tea m o n de ma n d
S U S A R
s us pecte d u ne x pecte d seri o us a d verse reacti o n
T BI
t otal b o d y irra diati o n
T Bili
t otal bilir u bi n
T E A E
treat me nt-e mer ge nt a d verse e ve nt
T KI
t yr osi ne ki nase i n hi bit or
T O C
ta ble of c o nte nt
U G T
uri di ne gl uc ur o n yl tra nsferase
U L N
u p per li mit of n or mal
U S
U nite d States
V O D
ve n o -occl usi ve disease
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 2
A b bre vi ati o n
Ter m
W B C
w hite bl o o d cell
W O C B P
w o ma n of c hil d beari n g p ote ntial
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 3
1 1. R E F E R E N C E S
1.
A n o n y m o us. Ca ncer facts & fi g ures 2 0 1 0. I n: A merica n Ca ncer S ociet y. Atla nta, G A;
2 0 1 0: 6 6.
2. 
B o ue D R, Le Bie n T W. E x pressi o n a n d str uct ure of C D 2 2 i n ac ute le u ke mia. Bl o o d 
1 9 8 8; 7 1( 5): 1 4 8 0 - 6.
3. 
Sa nt M, Alle ma ni C, Terea n u C, et al. I nci de nce of he mat ol o gic mali g na ncies i n E ur o pe 
b y  m or p h ol o gic s u bty pe:  res ults of t he H A E M A C A R E pr oject. Bl o o d 
2 0 1 0; 1 1 6( 1 9): 3 7 2 4 - 3 4.
4.
Mira n da -Fil h o A, Pi ñer os M, et al. E pi de mi ol o gical patter ns of le u kae mia i n 1 8 4 
c o u ntries: a p o p ulati o n -base d st u d y . La ncet Hae mat ol 2 0 1 8; 5:e 1 4 - 2 4.
5.
Fa derl S, Je ha S, Ka ntarjia n H M. T he bi ol o g y  a n d t hera py of a d ult ac ute l y m p h o blastic 
le u ke mia. Ca ncer 2 0 0 3; 9 8( 7): 1 3 3 7 - 5 4.
6.
T h o mas D A, Ka ntarjia n H, S mit h T L , et al. Pri mar y refract or y a n d rela pse d a d ult ac ute
l ym p h o blastic le u ke mia: c haracteristics, treat me nt res ults, a n d pr o g n osis wit h sal va ge
t hera p y. Ca ncer 1 9 9 9; 8 6( 7): 1 2 1 6-3 0.
7.
O' Brie n S, T h o mas D, Ra va n di F, et al. O utc o me of a d ults wit h ac ute l ym p h oc y tic
le u ke mia after sec o n d sal va ge t hera p y. Ca ncer 2 0 0 8; 1 1 3( 1 1): 3 1 8 6 -9 1.
8.
R o ba k T. Ac ute l y m p h o blastic le u kae mia i n el derl y patie nts: bi ol o gical c haracteristics
a n d t hera pe utic a p pr oac hes. Dr u gs A gi n g 2 0 0 4; 2 1( 1 2): 7 7 9 -9 1.
9.
Je ha S et al. Cl ofara bi ne f or t he treat me nt of ac ute l ym p h o blastic le u ke mia. E x pert Re v
A ntica ncer T her. 2 0 0 7 Fe b; 7( 2): 1 1 3 -8.
1 0.
Ra va n di F. Ma na gi n g
P hila del p hia c hr o m os o me -p ositi ve ac ute l ym p h o blastic le u ke mia:
r ole of t yr osi ne ki nase i nhi bit ors. Cli n L y m p h o ma M y el o ma Le u k. 2 0 1 1 A pr; 1 1( 2): 1 9 8 -
2 0 3.
1 1.
A d va ni A, C oiffier B, Cz ucz ma n M S, et al. Safet y, p har mac o ki netics, a n d preli mi nar y  
cli nical acti vit y of i n ot uz u ma b oz o ga mici n, a n o vel i m m u n oc o nj u gate f or t he treat me nt 
of B -cell n o n-H o d g ki n's l y m p h o ma: res ults of a p hase I st u d y. J Cli n O nc ol.
2 0 1 0; 2 8( 1 2): 2 0 8 5 -9 3.
1 2.
Ka ntarjia n H M, De A n gel o DJ, Stelljes M, et al.I n ot uz u ma b oz o ga mici n vs sta n dar d 
t hera py f or ac ute l y m p h o blastic le u ke mia. N E n gl J Me d 2 0 1 6; 3 7 5: 7 4 0 – 5 3.
1 3.
U nite d States pac ka ge i nsert, B E S P O N S A ® (i n ot uz u ma b oz o ga mici n) f or i njecti o n, f or 
i ntra ve n o us use.  I nitial U. S. A p pr o val: 2 0 1 7.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 4
1 4.
Carreras E, Bertz H, Arcese W, Ver na nt J -P, T o mas J -F, et al, I nci de nce a n d o utc o me of 
he patic ve n o -occl usi ve disease after bl o o d or marr o w tra ns pla ntati o n: a pr os pecti ve 
c o h ort st u d y of t he E ur o pea n Gr o u p f or bl o o d a n d marr o w tra ns pla ntati o n.  Bl o o d.  
1 9 9 8; 9 2: 3 5 9 9 - 3 6 0 4.
1 5.
De A n gel o DJ, St oc k W, Stei n A S, et al. I n ot uz u ma b oz o ga mici n i n a d ults wit h rela pse d 
or refract or y  C D 2 2 p ositi ve ac ute l y m p h o blastic le u ke mia: a p hase 1/ 2 st u d y . Bl o o d 
A d va nces 2 0 1 7; 1( 1 5): 1 1 6 7 - 1 1 8 0.
1 6.
He mat ol o gical Mali ga ncies C o m mittee of C hi na A nti -Ca ncer Ass ociati o n , G ui deli nes 
f or treat me nt a n d dia g n osis of a d ult ac ute ly m p h o blastic le u ke mia i n C hi na ( 2 0 1 6 
e diti o n), Cli n J He mat ol, Oct o ber 2 0 1 6, v ol. 3 7, N o. 1 0 .
1 7.
K y mria h ™U nite d States Pac ka ge I nsert [ U S PI ].
1 8.
Bli nc y t o® U nite d States Pac ka ge I nsert [U S PI ]. 
1 9.
Mar qi b o
® U nite d States Pac ka ge I nsert [U S PI ].
2 0.
M o ht y  M, Malar d F, A becassis M, et al, Re vise d dia g n osis a n d se verity criter ia f or 
si n us oi dal o bstr ucti o n s y n dr o me/ ve n o-occl usi ve disease i n a d ult patie nts: a ne w 
classificati o n fr o m t he E ur o pea n S ociet y f or Bl o o d a n d Marr o w Tra ns pla ntati o n Bl o o d 
Marr o w Tra ns pla ntati o n. 2 0 1 6; 5 1: 9 0 6 - 9 1 2. 
2 1.
C hes o n et. al., Re vise d rec o m me n dati o ns o f t he I nter nati o nal W or ki n g Gr o u p f or 
Dia g n osis, Sta n dar dizati o n of Res p o nse Criteria, Treat me nt O utc o mes, a n d Re p orti n g 
Sta n dar ds f or T hera pe utic Trials i n Ac ute M yel oi d L e u ke mia. J Cli n O nc ol. 2 0 0 3 Dec 
1 5; 2 1( 2 4): 4 6 4 2 - 9
2 2.
R u ut u T, Eri kss o n B, Re mes K, et al , Urs o de o x yc h olic aci d f or t he pre ve nti o n of 
he patic c o m plicati o ns i n all o ge neic ste m cell tra ns pla ntati o n.  Bl o o d. 2 0 0 2, Se p 1 5; 1 0 0 
( 6): 1 9 7 7 8 3.
2 3.
R u ut u T, J u v o ne n E, Re m ber ger M, et al, I m pr o ve d s ur vi val wit h urs o de o x y c h olic aci d 
pr o p h y la xis i n all o ge neic ste m cell tra ns pla ntati o n: l o n g ter m f oll o w u p of a ra n d o mize d 
st u d y. Bi ol Bl o o d Marr o w Tra ns pla nt. 2 0 1 4 Ja n; 2 0( 1): 1 3 5 8.
2 4.
Ye h R F, Pa wli k o ws ki M A, Bl o u g h D K, et al. Acc urate tar geti n g of dail y i ntra ve n o us 
b us ulfa n wit h 8 h o ur bl o o d sa m pli n g i n h os pitali ze d a d ult he mat o p oietic cell tra ns pla nt 
reci pie nts. Bi ol Bl o o d Marr o w Tra ns pla nt. 2 0 1 2; 1 8: 2 6 5 2 7 2.
2 5.
Ric har ds o n P G, S oiffer RJ, A nti n J H, et al, Defi br oti de f or t he treat me nt of se vere 
he patic ve n o occl usi ve disease a n d m ulti or ga n fail ure after ste m cell tra ns pla ntati o n: a 
m ultice nter, ra n d o mize d, d ose fi n di n g trial. Bi ol Bl o o d Marr o w Tra ns pla nt. 2 0 1 0 J ul; 
1 6( 7): 1 0 0 5 1 7.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)

I n ot uz u ma b oz o ga mici n ( P F-0 5 2 0 8 7 7 3)
Pr ot oc ol B 1 9 3 1 0 3 4
Fi nal Pr ot oc ol A me n d me nt 2 , 1 5 Ma y
2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P O nc ol o g y Cli nical Pr ot oc ol Te m plate ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 5
2 6.
（Ⅲ）— —
（2 0 2 0 
2 0 2 0- 0 7- 2 0 
( C M A, C HI N E S E 
M E DI C A L  A S S O CIA TI O N),
.
2 7.
（c G V H D）
（2 0 2 1 
2 0 2 1 - 0 4-
3 0 
( C M A, C HI N E S E M E DIC A L  A S S O CI A TI O N),
.
2 8.
He mat ol o g y  O nc ol o g y C o m mittee, C hi nese A nti-Ca ncer Ass ociati o n; Le u ke mia & 
L y m p h o ma Gr o u p, C hi nese S ociet y of He mat ol o g y, C hi nese Me dical Ass ociati o n. 
[ C hi nese g ui deli nes f or dia g n osis a n d treat me nt of a d ult ac ute l y m p h o blastic le u ke mia 
( 2 0 2 1)]. Z h o n g h ua X ue Ye X ue Za Z hi. 2 0 2 1 Se p 1 4; 4 2( 9): 7 0 5-7 1 6. C hi nese. d oi: 
1 0. 3 7 6 0/c ma.j.iss n. 0 2 5 3 -2 7 2 7. 2 0 2 1. 0 9. 0 0 1. P MI D: 3 4 7 5 3 2 2 4; P M CI D: P M C 8 6 0 7 0 4 6.
0 9 0 1 7 7 e 1 9 d 7 5 3 4 3 7\ A p pr o v e d\ A p pr o v e d O n: 1 7- M a y- 2 0 2 3 0 0: 5 5 ( G M T)
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt