Conditions: UC (Urothelial Cancer)
Keywords: Urothelial carcinoma fibroblast growth factor (FGF) fibroblast growth factor receptor (FGFR) FGF/FGFR alterations
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

Detailed description:

Arms:
arm 1: Pemigatinib in subjects with FGFR3 mutations or fusions. arm 2: Pemigatinib in subjects with FGFR3 mutations or fusions. arm 3: Pemigatinib in subjects with other FGF/FGFR alterations.

Interventions: intervention 1: pemigatinib intervention 2: pemigatinib
Intervention descriptions: intervention 1: Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy. intervention 2: Pemigatinib once a day by mouth continuously.

Protocol document:
Prot_000.pdf: 
Official Title: 
NCT Number: 
Document Date: 
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the 
Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With 
Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring 
FGF/FGFR Alterations - (FIGHT-201)
NCT02872714
Clinical Study Protocol Amendment 7: 09 March 2020


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>	>
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?C$ 	<<	<C

	A<$ C		H
ghijklnopqoprksoh
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{y}y{yy


	
	

	
	
 !
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()*+,./0.1(,1(2
34"33555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
'3&"#!%&"3
555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
5
&!"$8&"
555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
55
9	:;
55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
555
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#<	<=	>?#	!
	?<	"5555555555555555555555555555555555555555
55
3:;!
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555
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!		;:::$!
555555555555555555555555555555555555555555555
565
!9;?&	!
55555555555555555555555555555555555555555555
5655
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!9;	3
555555555555555555555555555555555555
5655
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!9;3
55555555555555555555555555555555555555555
56555
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5555555555555555555555555555555555555555555555555555555555
56565

?A
555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
5
3&8$4"B%&%3$%$"&3
55555555555555555555555555555555555555555555555555555555555555
55
3:;"<CD
555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
555

		"<CD
5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
555

3;	"<CD5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
5565

%A
		"<CD
55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
55
3:;%;

5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
555

		%;

55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
555

3;	%;

55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
5565

%A
		%;

555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
65
38B%&%'='&4
5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
655
3:<C:		
5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555
655
3:<C%A:		
5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
5
%3&=&"''
55555555555555555555555555555555555555555555555555555555555555555555555555555555555556
55
"D	3:;$
555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
55
 :	&9D;
555555555555555555555555555555555555555555555555555555555555555555555555555555555556
565
:<	3:<C55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
55
$:	&	;3:<C	

55555555555555555555555555555555555555555555555555555556
55
"D	3:;$:	555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
5E5
3:;&	5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555556
FGHIJKMNOPNOQJRNG
FSMTUVWXWYXZ[M\]
^Q_K`
ZX\a^XZXX


	
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=JDKLMNONPOQRDST
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SAP_001.pdf: 
Official Title: 
NCT Number: 
Document Date: 
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the 
Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With 
Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring 
FGF/FGFR Alterations - (FIGHT-201)
NCT02872714
Statistical Analysis Plan Version 1 : 12 June 2019


Incyte Corporation 
Page 1 of 28 
INCB 54828-201 SAP Amendment 1 
12 JUN 2019 
CONFIDENTIAL 
STATISTICAL ANALYSIS PLAN 
 
INCB 54828-201 
A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the 
Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically 
Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations 
 
 
 
 
 
IND Number: 
 
Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Protocol Version: 
Protocol Amendment 6 dated 20 NOV 2018 
CRF Approval Date: 
03 OCT 2018 
SAP Version: 
Amendment 1 
SAP Author:  
 
, Biostatistics 
Date of Plan: 
12 JUN 2019 
 
 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 


Incyte Corporation 
Page 2 of 28 
INCB 54828-201 SAP Amendment 1 
12 JUN 2019 
CONFIDENTIAL 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..........................................................................................................5 
1. 
INTRODUCTION ........................................................................................................6 
2. 
INFORMATION, OBJECTIVES, AND ENDPOINTS ...............................................6 
2.1. 
Protocol and Case Report Form Version ......................................................................6 
2.2. 
Study Objectives ...........................................................................................................6 
2.2.1. 
Primary Objective .........................................................................................................6 
2.2.2. 
Secondary Objectives ...................................................................................................6 
 
6 
2.3. 
Study Endpoints ............................................................................................................7 
2.3.1. 
Primary Endpoint ..........................................................................................................7 
2.3.2. 
Secondary Endpoints ....................................................................................................7 
 
7 
3. 
STUDY DESIGN .........................................................................................................8 
3.1. 
Control of Type I Error .................................................................................................9 
3.2. 
Sample Size Considerations .......................................................................................10 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................10 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................10 
4.1.1. 
Day 1 ...........................................................................................................................10 
4.1.2. 
Study Day ...................................................................................................................10 
4.1.3. 
Baseline Value ............................................................................................................10 
4.1.4. 
Handling of Missing and Incomplete Data .................................................................11 
4.1.5. 
Cycle Length and Duration .........................................................................................11 
4.1.6. 
Analysis Window ........................................................................................................11 
4.2. 
Variable Definitions ....................................................................................................11 
4.2.1. 
Age ..............................................................................................................................11 
4.2.2. 
Body Mass Index ........................................................................................................11 
4.2.3. 
Prior and Concomitant Medication .............................................................................11 
5. 
STATISTICAL METHODOLOGY ...........................................................................12 
5.1. 
General Methodology .................................................................................................12 
5.2. 
Treatment Groups .......................................................................................................12 
5.3. 
Analysis Populations ..................................................................................................12 


Incyte Corporation 
Page 3 of 28 
INCB 54828-201 SAP Amendment 1 
12 JUN 2019 
CONFIDENTIAL 
5.3.1. 
Efficacy Evaluable Population ...................................................................................12 
5.3.2. 
Per Protocol Population ..............................................................................................12 
5.3.3. 
Safety Population ........................................................................................................13 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................13 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............13 
6.1.1. 
Demographics .............................................................................................................13 
6.1.2. 
Baseline Disease Characteristics ................................................................................13 
6.1.3. 
Disease History ...........................................................................................................13 
6.1.4. 
Prior Therapy ..............................................................................................................13 
6.1.5. 
Medical History ..........................................................................................................14 
6.2. 
Disposition of Subjects ...............................................................................................14 
6.3. 
Protocol Deviations ....................................................................................................14 
6.4. 
Exposure .....................................................................................................................14 
6.5. 
Study Drug Compliance .............................................................................................14 
6.6. 
Prior and Concomitant Medication .............................................................................15 
7. 
EFFICACY .................................................................................................................15 
7.1. 
Efficacy Hypotheses ...................................................................................................15 
7.2. 
Analysis of the Primary Efficacy Parameter ..............................................................15 
7.2.1. 
Primary Efficacy Analysis ..........................................................................................15 
7.2.1.1. 
Response Criteria ........................................................................................................15 
7.2.1.2. 
Overall Response Rate and Best Response ................................................................15 
7.2.2. 
Subgroup Analysis for the Primary Endpoint .............................................................16 
7.3. 
Analysis of the Secondary Efficacy Parameters .........................................................16 
7.3.1. 
Secondary Endpoints Involving Objective Response Rate ........................................16 
7.3.2. 
Progression-Free Survival ..........................................................................................16 
7.3.3. 
Overall Survival ..........................................................................................................17 
7.3.4. 
Duration of Response .................................................................................................18 
7.4. 
Other Efficacy Analyses .............................................................................................18 
7.4.1. 
Largest Percentage Reduction in Sum of Diameters of Target Lesions .....................18 
7.4.2. 
Investigator-Assessed Efficacy Parameters ................................................................18 
7.4.3. 
Eastern Cooperative Oncology Group Performance Status ........................................18 
8. 
SAFETY AND TOLERABILITY ..............................................................................19 


Incyte Corporation 
Page 4 of 28 
INCB 54828-201 SAP Amendment 1 
12 JUN 2019 
CONFIDENTIAL 
8.1. 
General Considerations ...............................................................................................19 
8.2. 
Adverse Events ...........................................................................................................19 
8.2.1. 
Adverse Event Definitions ..........................................................................................19 
8.2.2. 
Adverse Event Summaries ..........................................................................................19 
8.3. 
Clinical Laboratory Tests ...........................................................................................21 
8.3.1. 
Laboratory Value Definitions .....................................................................................21 
8.3.2. 
Laboratory Value Summaries .....................................................................................21 
8.4. 
Vital Signs ..................................................................................................................21 
8.5. 
Electrocardiograms .....................................................................................................22 
9. 
INTERIM ANALYSES ..............................................................................................22 
10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN ........................23 
10.1. 
Changes to Protocol-Defined Analyses ......................................................................23 
10.2. 
Changes to the Statistical Analysis Plan .....................................................................23 
10.2.1. 
Original to Amendment 1 ...........................................................................................23 
11. 
REFERENCES ...........................................................................................................24 
APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS ........................................25 
 
LIST OF TABLES 
Table 1: 
Evaluation and Censoring of Progression-Free Survival ............................................17 
Table 2: 
Criteria for Clinically Notable Vital Sign Abnormalities ...........................................22 
Table 3: 
Criteria for Clinically Notable Electrocardiogram Abnormalities .............................22 
Table 4: 
Statistical Analysis Plan Versions ..............................................................................23 
 
LIST OF FIGURES 
Figure 1: 
Study Design .................................................................................................................9 
 


Incyte Corporation 
Page 5 of 28 
INCB 54828-201 SAP Amendment 1 
12 JUN 2019 
CONFIDENTIAL 
LIST OF ABBREVIATIONS 
Abbreviation 
Term 
AE 
adverse event 
BMI 
body mass index 
CI 
confidence interval 
CR 
complete response 
CRF 
case report form 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
FGF 
fibroblast growth factor 
FGFR 
fibroblast growth factor receptor 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCI 
National Cancer Institute 
NE 
not evaluable 
ORR 
overall response rate 
OS 
overall survival 
PD 
progressive disease 
PFS 
progression-free survival 
PP 
per protocol 
PR 
partial response 
QTcF 
Fridericia correction 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
stable disease 
SI 
international system of units 
TEAE 
treatment-emergent adverse event 
TNM 
TNM Classification of Malignant Tumors 
WHO 
World Health Organization 
 


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1. 
INTRODUCTION 
This is a Phase 2, open-label, monotherapy study of INCB054828 in subjects with metastatic or 
surgically unresectable urothelial cancer harboring FGF/FGFR alterations.  A detailed 
description of the investigational product, target patient population, rationale for doses to be 
examined, and potential risks and benefits of treatment with INCB054828 is provided in 
Section 1 of the Protocol. 
The purpose of this SAP is to provide details of the statistical analyses that have been outlined in 
the Study INCB 54828-201 Protocol. 
2. 
INFORMATION, OBJECTIVES, AND ENDPOINTS 
2.1. 
Protocol and Case Report Form Version 
This SAP is based on INCB 54828-201 Protocol Amendment 6 dated 20 NOV 2018 and case 
report form (CRF) approved on 03 OCT 2018.  Unless superseded by an amendment, this SAP 
will be effective for all subsequent protocol amendments and eCRF versions. 
2.2. 
Study Objectives 
2.2.1. 
Primary Objective 
• To evaluate the objective response rate (ORR) of INCB054828 as a monotherapy in 
the treatment of metastatic or surgically unresectable urothelial carcinoma with 
fibroblast growth factor receptor 3 (FGFR3) mutations or fusions. 
2.2.2. 
Secondary Objectives 
• To evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or 
surgically unresectable urothelial cancer with different molecular subgroups. 
• To evaluate the safety and tolerability of INCB054828. 
• To evaluate other clinical efficacy measurements, including duration of response 
(DOR), progression-free survival (PFS), and overall survival (OS). 


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2.3. 
Study Endpoints 
2.3.1. 
Primary Endpoint 
• Objective response rate in subjects with FGFR3 mutations or fusions based on central 
genomics laboratory results and INCB054828 administered using a continuous dose 
regimen (Cohort A-CD).  Response will be based on a review of scans by a 
centralized radiological review committee. 
2.3.2. 
Secondary Endpoints 
• Objective response rate in subjects with FGFR3 mutations or fusions based on central 
genomics laboratory results and using an intermittent dose regimen (Cohort A-ID).  
Response will be based on review of scans by a centralized radiological review 
committee. 
• Objective response rate in subjects with FGFR3 mutations or fusions based on central 
genomics laboratory results and using a continuous dose regimen (Cohort A-CD).  
Response will be based on review of scans by centralized radiological review 
committee. 
• Objective response rate in all subjects receiving INCB054828 administered as 
continuous dose regimen or intermittent dose regimen (Cohorts A-ID, A-CD, and B 
combined).  Response will be based on review of scans by a centralized radiological 
review committee. 
• Objective response rate in subjects with all other FGF/FGFR alterations (Cohort B).  
Response will be based on a review of scans by a centralized radiological review 
committee. 
• PFS (Cohort A-ID, Cohort A-CD, and Cohort B, separately). 
• DOR (Cohort A-ID, Cohort A-CD, and Cohort B, separately). 
• OS (Cohort A-ID, Cohort A-CD, and Cohort B, separately). 
• Safety and tolerability, assessed by monitoring frequency, duration, and severity of 
adverse events (AEs); through physical examinations; by evaluating changes in vital 
signs and electrocardiograms (ECGs); and through clinical laboratory blood and urine 
sample evaluations. 


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3. 
STUDY DESIGN 
This is an open-label monotherapy study of INCB054828 in subjects with metastatic or 
surgically unresectable urothelial cancer harboring FGF/FGFR alterations.  Subjects will receive 
INCB054828 at a once daily starting dose of 13.5 mg on a 2-weeks-on-therapy and 
1-week-off-therapy schedule. 
Protocol Amendment 5 introduces a new dose regimen for INCB054828 (13.5 mg continuous 
dose regimen [no planned dose holiday]).  Subjects receiving a continuous dose regimen will be 
enrolled in a new cohort (Cohort A-CD).  Note:  Subjects enrolled in the current Cohort A 
(intermittent dose regimen [Cohort A-ID]) will continue to receive treatment with INCB054828 
as 2-weeks-on/1-week-off therapy. Subjects in Cohort A-ID will not switch to a continuous dose 
regimen. 
Subjects can enroll if they have a known FGF/FGFR alteration and have either:  (a) failed at least 
1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma 
(ie, chemotherapy, immunotherapy) or (b) have not received chemotherapy for metastatic or 
surgically unresectable urothelial carcinoma due to poor performance status (ie, ECOG 
performance status of 2) and have insufficient renal function (ie, creatinine clearance 
< 60 mL/min or local guidelines). 
Potential subjects can be screened/enrolled based on local genomic sequencing but must have 
their tumor samples sequenced through the sponsor's central laboratory.  The results from the 
central laboratory will be considered final.  In cases where the central laboratory does not show 
an alteration, the investigator will decide if continuing treatment is in the best interest of the 
subject; however, the subject will not be included in the efficacy analyses and may be replaced. 
The study will enroll approximately 240 subjects: 
• Cohort A-ID:  FGFR3 mutations or fusions (n = 100); this cohort will complete 
enrollment before Cohort A-CD begins enrolling subjects. 
• Cohort A-CD:  FGFR3 mutations or fusions (n = 100). 
• Cohort B:  all other FGF/FGFR alterations (n = 40). 
Once a subject has completed screening and has enrolled into the study, treatment will start on 
Day 1.  Subjects will undergo routine safety assessments during treatment as well as routine 
efficacy assessments.  Subjects will be allowed to continue receiving study drug in 21-day cycles 
until documented disease progression or unacceptable toxicity is reported. 
In addition to introducing continuous dosing, up-titration will be implemented.  Any subject who 
does not reach the target serum phosphate level of > 5.5 mg/dL will increase the daily dose to 
18mg. 
The overall study design is shown in Figure 1. 


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Figure 1: 
Study Design 
 
3.1. 
Control of Type I Error 
All statistical analyses are exploratory in nature.  Unless otherwise specified, all confidence 
intervals (CIs) provided will be at the 95% confidence level. 
Metastatic or surgically unresectable 
urothelial carcinoma
FGF/FGFR status
Enroll
Begin dosing QD 
(oral), 2 weeks on 
and 1 week off 
therapy
Clinical 
assessment after 
Cycle 3
Disease Progression
Stable Disease or 
Response (PR or CR)
Discontinue treatment; 
safety and survival 
follow-up
Continue treatment 
on 21-day cycle; 
clinical assessments 
every 3 cycles
Negative
Positive
Not eligible
Screen
Cohort A-CD
(FGFR3 mutations or 
fusions)
Cohort A-ID
(FGFR3 mutations or 
fusions)
Cohort B
(all other FGF/FGFR 
alterations)
Begin dosing QD 
(oral), continuously


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3.2. 
Sample Size Considerations 
Approximately 100 subjects who have FGFR3 mutations or fusions based on central genomics 
laboratory results are planned per each Cohort A-ID and Cohort A-CD.  An agent used in the 
second-line setting that has an ORR of 35% would be considered clinically meaningful.  With 
the assumed rates of 35% for the intervention, a sample size of approximately 100 subjects per 
each Cohort A-ID and Cohort A-CD would provide a 95% CI with a lower limit of > 25%, 
assuming 10% lost to follow-up.  Approximately 40 subjects will be enrolled in Cohort B (all 
other FGF/FGFR alterations), which will provide > 80% chance of observing at least 
6 responders if the underlying ORR is 20%. 
Subjects enrolled without known FGF/FGFR alteration from the sponsor's central laboratory will 
not be included in the efficacy analyses and may be replaced. 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1 
Day 1 is the date that first dose of study drug (INCB054828) is administered to the subjects. 
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as  
Day # = (Visit/Reporting Date –Day 1 date + 1).  
If the visit/reporting date is before the Day 1 date, then the study day at the visit/reporting date 
will be calculated as  
Day # = (Visit/Reporting Date – Day 1 date). 
A study day of -1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Baseline is defined as the last nonmissing measurement obtained prior to the first administration 
of INCB054828.  When scheduled assessments and unscheduled assessments occur on the same 
day and time of the assessment or time of first dose is not available, use the following convention 
to determine baseline: 
• If both a scheduled and an unscheduled visit are available on the day of the first dose, 
and the time is missing, use the scheduled assessment as baseline. 
• If all scheduled assessments are missing on the day of the first dose, and an 
unscheduled assessment is available, use the unscheduled assessment as baseline. 


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4.1.4. 
Handling of Missing and Incomplete Data 
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in this section or relevant sections. 
Partial disease/cancer diagnosis date will be handled as follows:  
• If only the day is missing, then the imputed day will be the first of the month.  
• If both the month and day are missing, then the imputed day and month will be 
01 JAN.  
• No imputation will be done if the date is completely missing.  
For relevant efficacy endpoints, partial death date will be imputed as follows:  
• If mmyyyy for the last contact date = mmyyyy for the death date, then the death date 
will be set to the day after the last contact date.  
• If mmyyyy for the last contact date < mmyyyy for the death date, then the death date 
will be set to the first day of the death month.  
• Otherwise, the partial death date will not be imputed.  
4.1.5. 
Cycle Length and Duration 
Cycle 1 Day 1 is the day that the first dose of INCB054828 is administered.  Scheduled cycle 
length is 21 days, with first day of each cycle corresponding with the first day of INCB054828 
administration in that cycle.  
4.1.6. 
Analysis Window 
For parameters that will be summarized by visit, the nominal visit as recorded on the eCRF will 
be used.  There will be no additional analysis windowing done based on the assessment date. 
4.2. 
Variable Definitions 
The following variables will only be calculated if not reported on the eCRF.  
4.2.1. 
Age 
Subject age will be calculated as the integer part of the number of years from date of birth to the 
date of signing the informed consent form, using the following formula: 
Age = integer part of (date of informed consent – date of birth + 1) / 365.25 
4.2.2. 
Body Mass Index 
BMI will be calculated as follows:  
BMI (kg/m2) = [weight (kg)] / [height (m)]2 
4.2.3. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first dose of 
INCB054828. 


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Concomitant medication is defined as any nonstudy medication that is started accordingly:  
• Before the date of first administration of INCB054828 and is ongoing throughout the 
study or ends on/after the date of first study drug administration. 
• On/after the date of first administration of INCB054828 and is ongoing or ends 
during the course of study drug administration. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of INCB054828.  In the listing, it will be indicated whether a 
medication is prior-only, concomitant-only, or both prior and concomitant medication. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 
5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9.1 or later) will be used 
for the generation of all tables, graphs, and statistical analyses.  Descriptive summaries for 
continuous variables will include, but not be limited to, the number of observations, mean, 
standard deviation, median, minimum, and maximum.  Descriptive summaries for categorical 
variables will include the number and percentage of subjects in each category.   
5.2. 
Treatment Groups 
This is an open label, single-treatment group study.  Subjects will be summarized by cohort and 
by total. 
5.3. 
Analysis Populations 
5.3.1. 
Efficacy Evaluable Population 
The efficacy evaluable population includes all subjects enrolled in the study who have a known 
FGF/FGFR alteration from the sponsor's central laboratory and received at least 1 dose of 
INCB054828.  The efficacy evaluable population will be used for analyses of all efficacy data. 
5.3.2. 
Per Protocol Population 
Subjects in the efficacy evaluable population who are considered to be sufficiently compliant 
with the Protocol compose the PP population. 
The following procedures will be performed to identify those subjects who are to be excluded 
from the PP population before the database freeze: 
• Clinical review of Protocol deviations/violations. 
• Clinical review of concomitant medications as defined in Section 5.6 of the Protocol. 
• Clinical review of the dose administration and drug accountability listing. 


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The determination of subjects being considered for exclusion from the PP population by the 
clinical team will be prepared and signed before database freeze. 
The PP population will be used in the supportive sensitivity analyses for efficacy endpoints. 
5.3.3. 
Safety Population 
The safety population includes all enrolled subjects who received at least 1 dose of 
INCB054828.  All safety analyses will be conducted using the safety population. 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES 
Appendix A provides a list of data displays and sample data displays. 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease 
History 
Demographic and baseline characteristics, disease history, and prior therapy will be summarized 
for the efficacy evaluable population and safety population and listed. 
6.1.1. 
Demographics 
The following demographic characteristics will be summarized for the efficacy evaluable 
population and safety population (if needed):  age, sex, race, ethnicity, weight (by gender), 
height, and BMI. 
6.1.2. 
Baseline Disease Characteristics 
The following baseline disease characteristics will be summarized for the efficacy evaluable 
population and safety population (if needed):  ECOG performance status and baseline phosphate. 
6.1.3. 
Disease History 
Time since diagnosis, stage at diagnosis, bladder cancer location at diagnosis, histology at 
diagnosis and baseline, and current TNM classification will be summarized.   
Time since diagnosis will be calculated as:  
Time since diagnosis (years) = (Day 1 date – date of diagnosis + 1) / 365.25 
6.1.4. 
Prior Therapy 
Number of subjects who received prior systemic cancer therapy and number of prior systemic 
cancer therapy regimens, number of subjects who received prior cisplatin, as well as the number 
of subjects who received prior immune therapy will be summarized for the efficacy evaluable 
population and safety population (if needed).  Immune therapy includes but not is not limited to 
the following terms:  atezolizumab, avelumab, durvalumab, nivolumab, pembrolizumab, 
tremelimumab, and ipilimumab.  Regimen name, component drugs, start and stop dates, purpose 
of the regimen, best response, reason for discontinuation, and date of relapse/progression will be 
listed. 


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Number of subjects who received prior radiation will be summarized for the efficacy evaluable 
population.  Radiotherapy type, body site, start and stop dates, total dose, and best response will 
be listed.  
Number of subjects who had prior surgery or surgical procedure for the malignancies under 
study will be summarized for the efficacy evaluable population.  Date and description of the 
surgery/procedure will be listed. 
6.1.5. 
Medical History 
For subjects in the efficacy evaluable population and safety population, medical history will be 
summarized by system organ class and preferred term and will be listed. 
6.2. 
Disposition of Subjects 
The number and percentage of subjects who were treated, discontinued study treatment with a 
primary reason for discontinuation, and discontinued from the study with a primary reason for 
withdrawal will be summarized for the efficacy evaluable population and safety population (if 
needed). 
6.3. 
Protocol Deviations 
Protocol deviations collected on the eCRF will be summarized descriptively and listed. 
6.4. 
Exposure 
For subjects in the safety population, exposure to INCB054828 will be summarized descriptively 
as the following: 
• Number of treatment cycles:  Number of cycles with a nonzero dose of 
INCB054828 
• Duration of treatment (days):  date of last dose of INCB054828 – date of first dose 
of INCB054828 + 1 
• Average daily dose (mg/day):  total actual INCB054828 dose taken (mg) / duration 
of treatment (days) 
6.5. 
Study Drug Compliance 
Overall compliance, total prescribed dose, and total actual dose of INCB054828 will be 
summarized descriptively and listed for subjects in the safety population. 
Overall compliance (%) for INCB054828 will be calculated for all subjects as: 
compliance (%) = 100 × [total dose actually taken] / [total prescribed dose] 
The total prescribed dose is defined as the sum of the doses prescribed by the investigator 
accounting for dose modifications. 
The total actual dose taken will be calculated based on information entered on the drug 
accountability eCRF.  If there is dispensed drug that has not been returned yet, the actual dose 


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taken starting from the dispense date of the unreturned drug will be imputed by the dose taken as 
reported on the dosing eCRF. 
6.6. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary.  
For subjects in the safety population, the number and percentage of subjects with prior and 
concomitant medications will be summarized by WHO drug class and WHO drug term.  In the 
data listing, each medication will be recorded as prior, concomitant, or both prior and 
concomitant. 
7. 
EFFICACY 
Appendix A provides a list of data displays and sample data displays. 
7.1. 
Efficacy Hypotheses 
Not applicable. 
7.2. 
Analysis of the Primary Efficacy Parameter 
7.2.1. 
Primary Efficacy Analysis 
The primary endpoint of the study is ORR in subjects with FGFR3 mutations or fusions based on 
the central genomics laboratory results and on a continuous dose regimen, defined as the 
proportion of subjects with best response of CR or PR based on review of scans by an 
independent centralized radiological review committee per RECIST v1.1 (Eisenhauer et al 
2009).  Confirmation of CR and PR is required and documented in the Independent Review 
Charter.  This analysis will be based on the efficacy evaluable population.  Subjects who do not 
have sufficient baseline or on-study response assessment information to be adequately assessed 
for response status will be included in the denominators in the calculation of ORR.  The 95% CI 
for the ORR will be calculated using the Clopper-Pearson method. 
The ORR will also be analyzed based on the PP population as sensitivity analysis. 
7.2.1.1. 
Response Criteria 
Objective assessment of tumor status will be evaluated by an independent central radiological 
review committee based on RECIST v1.1, and response status will be logged into the eCRF. 
Response status will be recorded at each response assessment visit as CR, PR, SD, PD, or NE. 
7.2.1.2. 
Overall Response Rate and Best Response 
A subject is considered an objective responder if they have a best overall response of CR or PR 
at any postbaseline visit prior to first PD. 
In general, best overall response is the best response recorded postbaseline prior to and including 
the first PD, in the order of CR, PR, SD, PD, and NE.  A best overall response of CR or PR 
needs to be confirmed, and confirmation method is described in the Independent Review Charter.  
In the case of SD, measurements must meet the SD criteria at least once after the date of first 


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dose at a minimum interval of 49 days.  Subjects that fail to meet this criterion will have best 
overall response of PD if the next available assessment indicates PD or NE if there is no 
additional assessment available. 
7.2.2. 
Subgroup Analysis for the Primary Endpoint 
Subpopulation analysis of the primary endpoint will be performed based on appropriate intrinsic 
and extrinsic factors if needed. 
7.3. 
Analysis of the Secondary Efficacy Parameters 
7.3.1. 
Secondary Endpoints Involving Objective Response Rate 
The secondary endpoints involving ORR in this study include the following: 
• ORR in subjects with FGFR3 mutations or fusions based on central genomics laboratory 
results and using an intermittent dose regimen (Cohort A-ID).  Response will be based on 
review of scans by a centralized radiological review committee. 
• ORR in subjects with FGFR3 mutations or fusions based on central genomics laboratory 
results and using a continuous dose regimen (Cohort A-CD) and intermittent dose 
regimen (Cohort A-ID).  Response will be based on review of scans by centralized 
radiological review committee. 
• ORR in all subjects receiving INCB054828 administered as continuous dose regimen and 
intermittent dose regimen (Cohorts A-ID, A-CD, and B, combined).  Response will be 
based on review of scans by a centralized radiological review committee. 
• ORR in subjects with all other FGF/FGFR alterations (Cohort B).  Response will be 
based on review of scans by a centralized radiological review committee. 
The secondary endpoints involving ORR will be analyzed in the same way as the primary 
endpoint, and the 95% CI for ORR will be calculated using exact method for binomial 
distribution.  Confirmation of CR and PR is required and documented in the Independent Review 
Charter. 
7.3.2. 
Progression-Free Survival 
Progression-free survival is defined as the length of time from the start of the study drug (Day 1) 
to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent 
centralized radiological review committee.  The date of PD will be the timepoint at which 
progression is first recorded.  Censoring for PFS will follow the algorithm outlined in Table 1, 
which is based on the FDA Guidance for Industry:  Clinical Trial Endpoints for the Approval of 
Cancer Drugs and Biologics (FDA 2015, FDA 2018). 
The number of subjects who progressed or died and the number of subjects censored will be 
summarized.  The Kaplan-Meier estimate of median PFS will be presented with its 95% CI.  The 
95% CI will be calculated using the Brookmeyer and Crowley's method (Brookmeyer and 
Crowley 1982).  The PFS analysis will be conducted for Cohorts A-ID, A-CD, and B. 


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Table 1: 
Evaluation and Censoring of Progression-Free Survival 
Situation 
Outcome 
Date of Progression or Censoring 
No baseline tumor assessment  
Censored 
Day 1 
No adequate postbaseline 
response assessment  
Censored 
Day 1 
Progression documented 
between scheduled response 
assessments  
Progressed 
Date of first overall response of 
progressive disease 
No progression  
Censored 
Date of last adequate response assessment 
(not NE and not missing) 
Study discontinuation for 
undocumented progression  
Censored 
Date of last adequate response assessment 
(not NE and not missing) 
Study discontinuation for 
toxicity or other reason  
Censored 
Date of last adequate response assessment 
(not NE and not missing) 
New anticancer treatment 
started  
Censored 
Date of last adequate response assessment 
(not NE and not missing) prior to starting 
of the new anticancer treatment 
Death before first progressive 
disease assessment  
Progressed 
Date of death 
Death between adequate 
assessment visits  
Progressed 
Date of death 
Death or progression after 
more than 1 missed 
assessment  
Censored 
Date of last adequate response assessment 
(not NE and not missing) 
7.3.3. 
Overall Survival 
Overall survival is defined as the length of time from the start of the study drug (Day 1) until the 
date of death due to any cause.  Date of death will be determined using the Death Report and the 
Survival Follow-Up eCRFs.  Subjects who are lost-to-follow-up or still alive at the time of 
analysis will be right-censored at the earlier of the date the subject was last known alive and the 
clinical data cut-off date for the analysis.  The last known alive date is defined as the later of the 
last study visit and the date the subject was last known alive from the Survival Follow-Up and 
Subject Status eCRFs. 
The number of subjects who died and the number of subjects censored will be summarized.  The 
Kaplan-Meier estimate of median OS will be presented with its 95% CI.  The 95% CI will be 
calculated using the Brookmeyer and Crowley's method (Brookmeyer and Crowley 1982).  The 
OS analysis will be conducted for Cohorts A-ID, A-CD, and B. 


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7.3.4. 
Duration of Response 
For objective responders, DOR is the time from the first overall response contributing to an 
objective response as assessed by an independent centralized radiological review committee to 
the earlier of death or first overall response of PD occurring after the first overall response 
contributing to the objective response.  Censoring of DOR will follow the same algorithm as the 
censoring of PFS (see Section 7.3.2). 
The total number of responders, the number of subjects who progressed or died, and the number 
of subjects censored will be summarized.  The Kaplan-Meier estimate of median DOR will be 
presented with its 95% CI.  The 95% CI will be calculated using the Brookmeyer and Crowley's 
method (Brookmeyer and Crowley 1982).  The DOR analysis will be conducted for 
Cohorts A-ID, A-CD, and B. 
7.4. 
Other Efficacy Analyses 
7.4.1. 
Largest Percentage Reduction in Sum of Diameters of Target Lesions 
For subjects with measurable lesions at baseline, target lesion sizes will be measured by sum of 
diameters.  The best percent change from baseline, defined as the largest decrease in target lesion 
size during the study, will also be summarized, and a waterfall plot of best percent change will 
be generated. 
Target lesions considered "too small to measure" will be assigned a default value of 5 mm for 
purposes of this analysis.  Likewise, target lesions identified as "not present" at postbaseline 
assessments will be assigned 0 mm for this analysis.  In the event a target lesion is unaccounted 
for in a particular postbaseline timepoint (ie, the assessment is missing or NE), then the overall 
sum of diameters for target lesions will not be evaluable for that postbaseline timepoint. 
7.4.2. 
Investigator-Assessed Efficacy Parameters 
ORR, PFS, and DOR based on review of scans by investigator per RECIST v1.1 will be 
analyzed in a similar fashion as those parameters assessed by an independent centralized 
radiological review committee.  Confirmation of CR and PR is not required. 
ORR and DOR assessed by an independent centralized radiological review committee per 
RECIST v1.1 without requirement of CR and PR confirmation will also be analyzed. 
7.4.3. 
Eastern Cooperative Oncology Group Performance Status 
ECOG performance status and changes in status at scheduled assessment times will be 
summarized. 


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8. 
SAFETY AND TOLERABILITY 
Appendix A provides a list of data displays and sample data displays.  
8.1. 
General Considerations 
The analyses for this section will be provided for the safety population.  Summary tables may be 
replaced with listings when appropriate.  For instance, an AE frequency table may be replaced 
with a listing if it only contains a few unique preferred terms reported on relatively few subjects.   
8.2. 
Adverse Events 
8.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after 
first dose of study drug and within 30 days of last dose of study drug.  Analysis of AEs (as 
discussed below) will be limited to TEAEs, but data listings will include all AEs regardless of 
their timing to study drug administration. 
Adverse events will be tabulated by MedDRA preferred term and system organ class.  Severity 
of AEs will be described and graded using the NCI CTCAE v4.03.  The CTCAE reporting 
guidelines and grading details are available on the Cancer Therapy Evaluation Program website.  
A grading (severity) scale is provided for each AE term.  If the toxicity is not included in the 
CTCAE v4.03 criteria, it will be rated on a scale of 1 to 4 as follows:  1 = mild, 2 = moderate, 
3 = severe and 4 = life-threatening.  All toxicities will be graded based on the worst level 
reached, not the level they may have reached if they had not been treated.  When the intensity of 
an AE changes over time for a reporting period (eg, between visits), each change in intensity will 
be reported as an AE until the event resolves. 
The subset of AEs considered by the investigator to be related to study drug will be considered to 
be treatment-related AEs.  The incidence of AEs and treatment-related AEs will be tabulated.  
Serious adverse events will also be tabulated.  
Any missing onset date, causality, or severity must be queried for resolution.  Unsolved missing 
values will be handled according to the following rules: 
• An unsolved missing causality will be considered treatment related. 
• An unsolved missing severity will be identified as an unknown severity. 
For purposes of analysis, all AEs will be considered TEAEs unless the AE can unequivocally be 
defined as not treatment emergent.  
8.2.2. 
Adverse Event Summaries 
An overall summary of AEs by treatment group will include:   
• Number (%) of subjects reporting any TEAEs 
• Number (%) of subjects reporting any serious TEAEs 
• Number (%) of subjects reporting any Grade 3 or 4 TEAEs 


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• Number (%) of subjects reporting any TEAEs related to INCB054828 
• Number (%) of subjects who temporarily interrupted INCB054828 because of TEAEs 
• Number (%) of subjects who permanently discontinued INCB054828 because of 
TEAEs 
• Number (%) of subjects with INCB054828 dose reductions because of TEAEs 
• Number (%) of subjects who had a fatal TEAE 
The following summaries will be produced by MedDRA term (if ≤ 10 subjects appear in a table, 
a listing may be appropriate): 
• Summary of TEAEs by system organ class and preferred term 
• Summary of TEAEs by preferred term in decreasing order of frequency 
• Summary of TEAEs by system organ class, preferred term, and maximum severity 
• Summary of Grade 3 or higher TEAEs by system organ class and preferred term 
• Summary of Grade 3 or higher TEAEs by preferred term in decreasing order of 
frequency 
• Summary of INCB054828 treatment-related AEs by system organ class and preferred 
term 
• Summary of treatment-related AEs by preferred term in decreasing order of 
frequency 
• Summary of Grade 3 or higher INCB054828 treatment-related AEs by system organ 
class and preferred term 
• Summary of TEAEs leading to death by system organ class and preferred term 
• Summary of serious TEAEs by system organ class and preferred term 
• Summary of treatment-related serious TEAEs by system organ class and preferred 
term 
• Summary of TEAEs leading to INCB054828 dose interruption by system organ class 
and preferred term 
• Summary of TEAEs leading to INCB054828 dose reduction by system organ class 
and preferred term 
• Summary of TEAEs leading to discontinuation of INCB054828 by system organ 
class and preferred term 
• Summary of TEAEs and Grade 3 or Higher TEAEs by preferred term in decreasing 
order of frequency 
• Summary of treatment-emergent non-SAEs by system organ class and preferred term 


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8.3. 
Clinical Laboratory Tests 
8.3.1. 
Laboratory Value Definitions 
For numeric laboratory results, the change and percentage change from baseline will be 
calculated.  Baseline will be determined according to Section 4.1.3.  If there are multiple values 
that meet the criteria for baseline, the value from the central laboratory has priority over the 
value from the local laboratory.  Thereafter, additional rules may be provided after consultation 
with the medical monitor to delineate which value will be defined as baseline. 
Laboratory test values outside the normal range will be assessed for severity based on CTCAE 
grade or similar criteria where clinical intervention is required for CTCAE grading. 
8.3.2. 
Laboratory Value Summaries 
All test results and associated normal ranges from central laboratories will be reported in SI 
units.  All tests with numeric values will have a unique unit per test.  Any laboratory test results 
and associated normal ranges from local laboratories will be converted to SI units. 
For numeric laboratory values, baseline value, postbaseline value, change from baseline, and 
percent change from baseline will be summarized by visit.  In addition, laboratory values and 
mean change from baseline will be plotted over time for selected laboratory parameters, 
including creatinine, parathyroid hormone, phosphate, sodium, 25-hydroxyvitamin D, and 
1,25-dihidroxyvitamin D. 
For the laboratory parameters that have CTCAE grading, shift tables will also be presented 
showing change in CTCAE severity grade from baseline to worst grade postbaseline.  The 
denominator for the percentage calculation will be the number of subjects in the baseline 
category. 
Categorical laboratory data will be tabulated by visit at baseline and postbaseline visits where 
appropriate. 
8.4. 
Vital Signs 
Values at each scheduled visit, change, and percent change from baseline for vital signs, 
including systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, body weight, 
and body temperature will be summarized descriptively. 
Criteria for clinically notable vital sign abnormalities are defined in Table 2.  The abnormal 
values for subjects exhibiting clinically notable vital sign abnormalities will be listed.  Alert vital 
signs are defined as an absolute value outside the defined range and percentage change from 
baseline greater than 25%.  The abnormal values for subjects exhibiting alert vital sign 
abnormalities will also be listed. 


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Table 2: 
Criteria for Clinically Notable Vital Sign Abnormalities 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
> 155 mmHg 
< 85 mmHg 
Diastolic blood pressure 
> 100 mmHg 
< 40 mmHg 
Pulse 
> 100 bpm 
< 45 bpm 
Temperature 
> 38ºC 
< 35.5ºC 
Respiratory rate 
> 24/min 
< 8/min 
8.5. 
Electrocardiograms 
Twelve-lead ECGs including PR, QRS, QT, and QTcF intervals, as well as heart rate, will be 
obtained for each subject during the study.  Values at each scheduled visit, change, and percent 
change from baseline will be summarized for each ECG parameter.  Change and percent change 
from baseline will be calculated using the average of all nonmissing values before the first 
administration of INCB054828 as the baseline value. 
Criteria for clinically notable ECG abnormalities are defined in Table 3.  The abnormal values 
for subjects exhibiting clinically notable ECG abnormalities will be listed with study visit.  Alert 
ECG values are defined as both the absolute value outside the defined range and the percentage 
change greater than 25% (QRS 30%).  The abnormal values for subjects exhibiting alert ECG 
abnormalities will be identified and listed. 
Table 3: 
Criteria for Clinically Notable Electrocardiogram Abnormalities 
Parameter 
High Threshold 
Low Threshold 
QTcF 
> 460 msec 
< 295 msec 
PR 
> 220 msec 
< 75 msec 
QRS 
> 120 msec 
< 50 msec 
QT 
> 500 msec 
< 300 msec 
9. 
INTERIM ANALYSES 
A futility analysis will be performed when approximately 45 subjects with FGFR3 mutations or 
fusions who have been treated and have had at least 1 tumor assessment or have permanently 
discontinued study treatment in Cohort A-ID.  The study will be stopped for futility if 10 or 
fewer responders are observed, for which there is less than 15% probability of claiming ORR 
> 25% at final analysis. 


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10. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 4. 
Table 4: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
16 MAY 2017 
Amendment 1 
12 JUN 2019 
10.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
10.2. 
Changes to the Statistical Analysis Plan 
10.2.1. 
Original to Amendment 1 
The original SAP has been updated to incorporate Protocol Amendments 4, 5, and 6.  Specific 
changes are outlined below: 
• Moved analysis of largest percentage reduction in sum of diameters of target lesions 
from Section 7.3, Analysis of the Secondary Efficacy Parameters to Section 7.4, 
Other Efficacy Analyses. 
• Summaries of prior cisplatin use and prior immune therapy have been added. 
• Average daily dose has been updated to use duration of treatment as the denominator. 
• Investigator-assessed efficacy parameters have been added as other efficacy analyses. 
• Summary of weight has been moved from efficacy section to vital sign section. 


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11. 
REFERENCES 
Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 
1982;38:29-41. 
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247. 
Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval 
of Cancer Drugs and Biologics. 2018. https://www.fda.gov/downloads/Drugs/ 
Guidances/ucm071590.pdf. Accessed March 5, 2019. 
Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval 
of Non-Small Cell Lung Cancer Drugs and Biologics. 2015. https://www.fda.gov/ 
downloads/drugs/guidances/ucm259421.pdf. Accessed March 5, 2019. 


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APPENDIX A. PLANNED TABLES, FIGURES, AND LISTINGS 
This appendix provides a list of the planned tables, figures, and listings for the CSR.  Standard 
tables will follow the conventions in the Standard Safety Tables initial version.  Shells are 
provided for nonstandard tables.  In-text tables are identical in structure and content as appendix 
tables, but follow a Rich Text Format. 
The list of tables, figures, and listings and the shells are to be used as guidelines.  Modifications 
of the lists or shells that do not otherwise affect the nature of the analysis will not warrant an 
amendment to the SAP. 
Tables 
Table No. 
Title 
Population 
Baseline and Demographic Characteristics 
1.1.1 
Analysis Populations 
All Enrolled 
1.1.2 
Summary of Subject Disposition 
Efficacy 
1.1.3 
Summary of Number of Subjects Enrolled by Country and Site 
Efficacy 
1.1.4 
Summary of Protocol Deviations 
Efficacy 
1.2.1 
Summary of Demographics and Baseline Characteristics 
Efficacy 
1.2.2 
Summary of Disease History 
Efficacy 
1.2.3 
Summary of Prior Systemic Cancer Therapy 
Efficacy 
1.3 
Summary of General Medical History 
Efficacy 
1.4.1 
Summary of Prior Medications 
Efficacy 
1.4.2 
Summary of Concomitant Medications 
Efficacy 
Efficacy 
2.1.1 
Summary of Best Response and Overall Response Rate 
Efficacy 
2.1.2 
Summary of Best Response and Overall Response Rate 
Per Protocol 
2.2.1 
Summary of Duration of Response 
Efficacy 
2.2.2 
Summary of Progression-Free Survival 
Efficacy 
2.2.3 
Summary of Overall Survival 
Efficacy 
2.2.4 
Summary of Best Change in Target Lesion Size 
Efficacy 
2.3.1 
Summary of ECOG Performance Status 
Efficacy 
Safety 
3.1.1 
Summary of Study Drug Exposure  
Safety 
3.1.2 
Summary of Study Drug Compliance 
Safety 
3.2.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety 
3.2.2 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ Class 
and Preferred Term 
Safety 
3.2.3 
Summary of Treatment-Emergent Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
Safety 
3.2.4 
Summary of Treatment-Emergent Adverse Events by MedDRA System Organ 
Class, Preferred Term, and Maximum Severity 
Safety 
3.2.5 
Summary of Treatment-Emergent Grade 3 or Higher Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 


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Table No. 
Title 
Population 
3.2.6 
Summary of Treatment-Emergent Grade 3 or Higher Adverse Events by MedDRA 
Preferred Term in Decreasing Order of Frequency 
Safety 
3.2.7 
Summary of Treatment-Related Adverse Events by MedDRA System Organ Class 
and Preferred Term 
Safety 
3.2.8 
Summary of Treatment-Related Adverse Events by MedDRA Preferred Term in 
Decreasing Order of Frequency 
Safety 
3.2.9 
Summary of Treatment-Related Grade 3 or Higher Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 
3.2.10 
Summary of Treatment-Emergent Adverse Events With a Fatal Outcome by 
MedDRA System Organ Class and Preferred Term  
Safety 
3.2.11 
Summary of Treatment-Emergent Serious Adverse Events by MedDRA System 
Organ Class and Preferred Term  
Safety 
3.2.12 
Summary of Treatment-Emergent Serious Adverse Events by MedDRA Preferred 
Term in Decreasing Order of Frequency 
Safety 
3.2.13 
Summary of INCB054828 Treatment-Related Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term  
Safety 
3.2.14 
Summary of Treatment-Emergent Adverse Events Leading to INCB054828 Dose 
Interruption by MedDRA System Organ Class and Preferred Term  
Safety 
3.2.15 
Summary of Treatment-Emergent Adverse Events Leading to INCB054828 Dose 
Reduction by MedDRA System Organ Class and Preferred Term 
Safety 
3.2.16 
Summary of Treatment-Emergent Adverse Events Leading to Discontinuation of 
INCB054828 by MedDRA System Organ Class and Preferred Term  
Safety 
3.2.17 
Summary of Treatment-Emergent Adverse Events and Grade 3 or Higher Adverse 
Events by MedDRA Preferred Term in Decreasing Order of Frequency 
Safety 
3.2.18 
Summary of Treatment-Emergent Non-Serious Adverse Events by MedDRA 
System Organ Class and Preferred Term 
Safety 
Laboratory 
3.3.1 
Summary of Laboratory Values - Hematology 
Safety 
3.3.2  
Shift Summary of Hematology Values in CTC Grade - To the Worst Abnormal 
Value  
Safety 
3.3.3 
Summary of Treatment-Emergent Worsening of Laboratory Abnormalities - 
Hematology 
 
3.3.4 
Summary of Laboratory Values - Chemistry 
Safety 
3.3.5 
Shift Summary of Chemistry Values in CTC Grade - To the Worst Abnormal Value  
Safety 
3.3.6 
Summary of Treatment-Emergent Worsening of Laboratory Abnormalities - 
Chemistry 
 
3.3.7 
Summary of Laboratory Values - Coagulation 
Safety 
3.3.8 
Shift Summary of Coagulation Values in CTC Grade - To the Worst Abnormal 
Value  
Safety 
3.3.9 
Summary of Treatment-Emergent Worsening of Laboratory Abnormalities - 
Coagulation 
Safety 
3.3.10 
Summary of Laboratory Values - Urinalysis 
Safety 


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Table No. 
Title 
Population 
Vital Signs 
3.4.1 
Summary of Systolic Blood Pressure 
Safety 
3.4.2 
Summary of Diastolic Blood Pressure  
Safety 
3.4.3 
Summary of Pulse  
Safety 
3.4.4 
Summary of Body Temperature 
Safety 
3.4.5 
Summary of Respiratory Rate 
Safety 
3.4.6 
Summary of Body Weight 
Safety 
ECG 
3.5.1 
Summary of PR Interval (ms) From 12-Lead ECG 
Safety 
3.5.2 
Summary of QRS Interval (ms) From 12-Lead ECG 
Safety 
3.5.3 
Summary of QT Interval (ms) From 12-Lead ECG 
Safety 
3.5.4 
Summary of QTc Interval (ms) From 12-Lead ECG 
Safety 
3.5.5 
Summary of Heart Rate (bpm) From 12-Lead ECG 
Safety 
3.5.6 
Summary of Outliers of QT and QTc Interval Values From 12-Lead ECG 
Safety 
3.5.7 
Summary of Clinically Significant ECG Abnormalities 
Safety 
Figures 
Figure No. 
Title 
4.2.1 
Kaplan-Meier Estimates of Duration of Response (Efficacy) 
4.2.2 
Kaplan-Meier Estimates of Progression-Free Survival (Efficacy)  
4.2.3 
Kaplan-Meier Estimates of Overall Survival (Efficacy)  
4.3.1 
Waterfall Plot of Best Percent Change from Baseline in Target Lesion Size (Efficacy) 
4.3.2 
Swimmer Plot of Duration of Treatment (Efficacy) 
4.6 
Line Graph of Mean Change From Baseline for Selected Laboratory Values (Safety) 
Listings 
Listing No. 
Title 
2.1.1 
Analysis Population 
2.1.2 
Subject Enrollment and Disposition Status 
2.1.3 
Subject Inclusion and Exclusion Criteria 
2.2 
Protocol Deviations/Violations 
2.4.1 
Demographic and Baseline Characteristics 
2.4.2 
Bladder Cancer Disease History 
2.4.3 
Prior Systemic Therapy 
2.4.4 
Prior Surgery 
2.4.5 
Prior Radiotherapy 
2.4.6 
Post Therapy 
2.4.7 
Medical History 
2.4.8 
Prior and Concomitant Drug Treatments 
2.4.9 
FGF and FGFR Alterations 
2.5 
Study Drug Compliance 
2.6.1 
Best Overall Response, Duration of Response, Progression-Free Survival and Overall Survival  
2.6.2 
Investigator Reported Assessment by RECIST Criteria  


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Listing No. 
Title 
2.6.3 
Response Assessment:  Target Lesions 
2.6.4 
Response Assessment:  Non-Target Lesions 
2.6.5 
Response Assessment:  New Lesions 
2.6.6 
Tumor Tissue 
2.6.7 
ECOG Status 
2.7.1 
Study Drug Administration 
2.7.2 
Adverse Events  
2.7.3 
INCB054828 Treatment-Related Adverse Events 
2.7.4 
Adverse Events Leading to Interruption, Reduction, or Discontinuation of INCB054828 
2.7.5 
Serious Adverse Events 
2.7.6 
Adverse Events Leading to Death 
2.8.1.1 
Clinical Laboratory Values - Hematology 
2.8.1.2 
Clinical Laboratory Values - Chemistry 
2.8.1.3 
Clinical Laboratory Values - Coagulation 
2.8.1.4 
Clinical Laboratory Values - Urinalysis 
2.8.2.1 
Abnormal Clinical Laboratory Values - Hematology 
2.8.2.2 
Abnormal Clinical Laboratory Values - Chemistry 
2.8.2.3 
Abnormal Clinical Laboratory Values - Coagulation 
2.9.1 
Vital Signs 
2.9.2 
Abnormal Vital Sign Values 
2.9.3 
Alert Vital Sign Values 
2.10.1 
12-Lead ECG Values 
2.10.2 
Abnormal 12-Lead ECG Values 
2.10.3 
Alert 12-Lead ECG Values 
2.11.1 
Eye Examinations