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BLADDER

BREASTGASTROINTESTINAL

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HEMATOLOGICMALIGNANCIES

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LUNG

GYNECOLOGICONCOLOGYSOLID TUMORSFor more information, contact: medicalinformation@beigene.com

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BLADDER

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BLADDER

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HEMATOLOGICMALIGNANCIES

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BLADDER

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HEMATOLOGICMALIGNANCIES

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BLADDER

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BLADDER

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HEMATOLOGICMALIGNANCIES

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BLADDER

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HEMATOLOGICMALIGNANCIES

LIVER

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BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

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BLADDER

BREASTGASTROINTESTINAL

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BLADDER

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HEAD AND NECK

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LIVER

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Bladder Cancer
Investigational
Medicinal Product

Study

Tislelizumab (Anti-PD-1)+ Chemotherapy

BGB-A317-310

SchemaGeography

Disease Area of Research

China

1L advanced UBC

Abbreviations: 1L, ﬁrst line; PD-1, programmed cell death protein 1; UBC, urothelial bladder cancer.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

Phase
3

Registry Number
NCT03967977

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BGB-A317-310 Phase 3 Study in 1L UBCBLADDER

BREASTGASTROINTESTINAL

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LIVER

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1,2

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin + Gemcitabine + Tislelizumab(BGB-A317, Anti-PD-1 Antibody) Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-Line Treatment for Patients With
Locally Advanced or Metastatic Urothelial Carcinoma
Phase 3

Recruiting

Study Identiﬁers: BGB-A317-310, NCT03967977
Contact: clinicaltrials@beigene.com

Primary Endpoint: OS in ITT
Key Secondary Endpoints: ORR, DOR, HRQoL, Safety, PFS per the investigator, OS rate at 1 and 2 years

Key Eligibility Criteria• Histologically conﬁrmed urothelial
carcinoma• No previous therapy for locallyadvanced unresectable ormetastatic urothelial carcinoma

TreatmentR
1:1

Tislelizumab +Chemotherapy
Placebo +Chemotherapy

Tislelizumab

PlaceboStratiﬁcation

Study Treatment• Cisplatin vs Carboplatin• Visceral metastasis (yes vs no)
PD-L1 expression (high vs low)

• Tislelizumab 200 mg or placebo Q3W• Gemcitabine 1000 mg/m² Day 1, 8, Q3W• Cisplatin 70 mg/m² or carboplatin
AUC=4.5 Day 1 or Day 2, Q3W

Treatment Until
Unacceptable
Toxicity or
Disease Progression

Safety and Survival
Follow-up

Chemotherapy regimen will beadministered for up to 6 cycles

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: 1L, ﬁrst line; AUC, area under the curve; DOR, duration of response; HRQoL, health-related quality of life; ITT, intent to treat; ORR, objective response rate; OS, overall survival;
PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; Q3W, every 3 weeks.
REFERENCES: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03967977. Accessed December 1, 2022. 2. Data on ﬁle. BeiGene, Inc.
For more information, contact: medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Breast Cancer
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

BGB-43395 (CDK4 inhibitor)+/- fulvestrant +/- letrozole

BGB-43955-101

Australia,
United States

HR+/HER2- breast cancer

1

NCT06120283

BGB-43395 +/- fulvestrant+/- letrozole

BGB-43395-102

China

HR+/HER2- breast cancer

1

NCT06253195

Abbreviations: CDK4, cyclin-dependent kinase 4; HER2, human epidermal growth factor receptor 2; HR, hormone receptor.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Gastrointestinal Cancer

1

Investigational
Studies
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

LBL-007 (anti-LAG3) +/Tislelizumab (Anti-PD-1) +Bevacizumab + Capecitabine

BGB-A317-LBL-007-2011

Worldwide

Maintenance in unresectable ormetastatic MSS/mismatch
repair proﬁcient CRC

1/2

NCT05609370

LBL-007 + Tislelizumab +Chemotherapy

BGB-A317-LBL-007-2021

China, S. Korea,
Thailand

1L unresectable locally advanced ormetastatic ESCC

2

NCT06010303

Tislelizumab + Chemotherapy

BGB-A317-305

SchemaWorldwide

1L GC/GEJC

3

NCT03777657

Tislelizumab + Chemotherapy

BGB-A317-306

SchemaWorldwide

1L advanced ESCC

3

NCT03783442

Tislelizumab +Chemoradiotherapy

BGB-A317-311

SchemaChina

Localized ESCC

3

NCT03957590

Zanidatamab (Anti-HER2
bispeciﬁc antibody) +Chemotherapy +/- Tislelizumab

ZWI-ZW25-3012

Worldwide

1L HER2+ advanced/metastatic GC/EC

3

NCT05152147

BGB-B3227 (MUC1 x CD16A) +/Tislelizumab

BGB-B3227-101

Opening soon

Advanced gastrointestinal cancer

1

NCT06540066

Leads Biolabs collaboration; BeiGene has global research, development, and manufacturing rights, and exclusive commercialization rights outside of China.
Zymeworks/Jazz collaboration; BeiGene has exclusive development and commercialization rights in Asia (except Japan), Australia, and New Zealand.

2

Abbreviations: 1L, ﬁrst line; CRC, colorectal cancer; EC, esophageal cancer; ESCC, esophageal squamous cell carcinoma; GC, gastric cancer; GEJC, gastroesophageal junction carcinoma;
HER2, human epidermal growth factor receptor 2; LAG3, lymphocyte activation gene 3; MSS, microsatellite stable; MUC1, mucin 1; PD-1, programmed cell death protein 1.

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STUDY DESIGN-305

BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Active, not recruiting
PRIMARY ENDPOINT: PFS, OS
KEY SECONDARY ENDPOINTS: ORR, DOR, HRQoL, Safety

NOTE: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and they have no recurrence or disease progression for at least 6 months.

For more information, contact: medicalinformation@beigene.com
The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: 1L, first line; 5-FU, 5+fluorouracil; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GC gastric cancer; GEJC, gastroesophageal junction carcinoma; HER2, human epidermal growth factor receptor-2;
HRQoL, health-related quality of life; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.
REFERENCE: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03777657. Accessed December 1, 2022.

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STUDY DESIGN-306

BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Tislelizumab in Combination With Chemotherapy
as 1L Treatment in Advanced ESCC1
Active, not recruiting
PRIMARY ENDPOINT: OS
KEY SECONDARY ENDPOINTS: PFS, ORR/DOR per RECIST v1.1,
OS in PD-L1 ≥10%, HRQoL, and Safety• Histologically confirmed diagnosis of ESCC
• Stage IV, unresectable ESCC at first diagnosis OR unresectable,
locally advanced recurrent metastatic disease; if there is priorneoadjuvant/adjuvant therapy with platinum-based chemotherapy,
a treatment-free interval of at least 6 months is required• No prior PD-1 or PD-L1 therapy• No evidence of fistula (either esophageal/bronchial or esophageal/aorta)

For more information, contact: medicalinformation@beigene.com
The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: 1L, first line; 5-FU, 5+fluorouracil; DOR, duration of response; ESCC, esophageal squamous cell carcinoma; HRQoL, health-related quality of life; ORR, overall response rate; OS, overall survival;
PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.
REFERENCE: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03783442. Accessed December 1, 2022.

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STUDY DESIGN-311

A Phase 3 Trial in Localized ESCC1-3
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Active, not recruiting

STUDY IDENTIFIER: NCT03957590
CONTACT: clinicaltrials@beigene.com

PRIMARY ENDPOINT: PFS by BIRC per RECIST 1.1
SECONDARY ENDPOINTS: ORR and DOR by BIRC per RECIST 1.1, OS, HRQoL, Safety

KEY ELIGIBILITY

TREATMENT• Histologically confirmed ESCC (II-IVa)

Tislelizumab (up to 24 months)+ cCRT (2 cycles of Cisplatin/Paclitaxel+ radiation)• Suitable for cCRT
• Surgery is unsuitable/declined• ECOG PS 0,1

STRATIFICATION• Clinical TNM stage: II/III vs IVa

R

Treatment until PD or
unacceptable toxicity

1:1
Placebo (up to 24 months)+ cCRT (2 cycles ofCisplatin/Paclitaxel + radiation)• ECOG PS: 0 vs 1

For more information, contact: medicalinformation@beigene.com
The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: BIRC, blinded independent review committee; cCRT, concurrent chemoradiotherapy; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ESCC, esophageal squamous cell carcinoma; HRQoL, health-related quality of life;
IRC, independent review committee; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; TNM, tumor nodes metastasis.
REFERENCES: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03957590. Accessed December 1, 2022. 2. BeiGene Data on File. (Protocol BGB-A317-311). 3. Wang W et al. ASCO-GI 2020. TIP.

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Head and Neck Cancer

1

Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Tislelizumab (Anti-PD-1)+ Chemotherapy

BGB-A317-309

China, Thailand

1L advanced nasopharyngeal cancer

3

NCT03924986

Tislelizumab +/- Surzebiclimab(anti-TIM3) +/- LBL-007(anti-LAG3)

BGB-HNSCC-2011

Worldwide

1L recurrent or metastatic HNSCC

2

NCT05909904

Leads Biolabs collaboration; BeiGene has global research, development, and manufacturing rights, and exclusive commercialization rights outside of China.
Abbreviations: 1L, ﬁrst line; HNSCC, head and neck squamous cell carcinoma; LAG3, lymphocyte activation gene-3; PD-1, programmed cell death protein 1; TIM3, T cell immunoglobulin and mucin-domain containing-3.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIO
Hematologic Malignancies
Investigational
Medicinal Product

Study

Sonrotoclax + Zanubrutinib

BGB-11417-301

Sonrotoclax monotherapy

Geography

Disease Area of Research

Phase

Registry Number

Worldwide

TN CLL

3

NCT06073821

BGB-11417-201

Worldwide

R/R MCL2

NCT05471843

Sonrotoclax monotherapy

BGB-11417-202

China

R/R CLL/SLL

2

NCT05479994

Sonrotoclax monotherapy

BGB-11417-203

Worldwide

R/R WM

2

NCT05952037

Sonrotoclax monotherapy

BGB-11417-101

Worldwide

B-cell malignancies

1A/1B

NCT04277637

Sonrotoclax monotherapy

BGB-11417-102

China

B-cell malignancies

1

NCT04883957

Sonrotoclax + Azacitidine+/- Posaconazole

BGB-11417-103

Worldwide

Myeloid malignancies

1B/2

NCT04771130

Sonrotoclax + Dexamethasone+/- Carﬁlzomib

BGB-11417-105

WorldwideR/R multiple myeloma with t(11;14)

1B/2

NCT04973605

BGB-16673 (BTK-targeted CDAC)

BGB-16673-101

Worldwide

B-cell malignancies

1

NCT05006716

BGB-16673

BGB-16673-102

China

R/R MCL, R/R CLL

2

NCT05294731

BGB-21447 (BCL2 inhibitor)

BGB-21447-101

Australia, China

B-cell malignancies

1

NCT05828589

BGB-45035 (IRAK4 CDAC)

BGB-45035-101

Australia

Immunology & inﬂammation

1

NCT06342713

SchemaBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

PAGE 1 of 2
Abbreviations: BCL2, B-cell lymphoma 2; BTK, Bruton tyrosine kinase; CDAC, chimeric degradation activating compound; CLL, chronic lymphocytic leukemia; IRAK4, interleukin-1 receptor-associated kinase 4;
MCL, mantle cell lymphoma; R/R, relapsed/refractory; SLL, small lymphocytic lymphoma; TN, treatment naive; WM, Waldenstrom macroglobulinemia.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIO
Hematologic Malignancies
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Zanubrutinib

BGB-3111-309

Worldwide

Primary membranous nephropathy

3

NCT05707377

Zanubrutinib

BGB-3111-217

China

Lupus nephritis

2

NCT04643470

Zanubrutinib

BGB-3111-215

United States

Previously treated B-cell malignancies

2

NCT04116437

Zanubrutinib

BGB-3111-218

China

R/R DLBCL

22

NCT05068440

Zanubrutinib

BGB-3111-111

Japan

B-cell malignancies

1/2

NCT04172246

Zanubrutinib + Obinutuzumab

BGB-3111-308

SchemaWorldwide

R/R FL

3

NCT05100862

Zanubrutinib + Rituximab

BGB-3111-306

SchemaWorldwide

1L MCL

3

NCT04002297

Zanubrutinib + Rituximab

BGB-3111-308

SchemaWorldwide

R/R MZL

3

NCT05100862

Tislelizumab

BGB-A317-314

SchemaChina

R/R cHL

3

NCT04486391

Ociperlimab (Anti-TIGIT) +/Tislelizumab or Rituximab

AdvanTIG-101

China

R/R DLBCL

1B/2

NCT05267054

SchemaBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

PAGE 2 of 2
Abbreviations: 1L, ﬁrst line; cHL, classical Hodgkin lymphoma; CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma;
MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; R/R, relapsed/refractory; SLL, small lymphocytic lymphoma; TIGIT, T-cell immunoreceptor with Ig and ITIM domains.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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Study of Sonrotoclax Plus Zanubrutinib Compared With Venetoclax Plus
Obinutuzumab in Patients With TN CLL1
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Enrolling

Study Identiﬁers: BGB-11417-301, NCT06073821
Contact: clinicaltrials@beigene.com

Primary Endpoint: PFS by IRC
Secondary Endpoints: uMRD, ORR, PFS, OS, HRQoL, Safety

Key Eligibility Criteriadel(17p)
FISH Test
Screening• TN CLL• Measurable disease by CT/MRI• Adequate bone marrow, liver, and renal function• No transformation to aggressive lymphoma• No CNS involvement• No uncontrolled hypertension

Treatment

Follow-up
Zanubrutinib 160 mg PO BID until PD(n=~225)
Sonrotoclax PO + Zanubrutinib for
12 cycles* after 3 cycles of Zanubrutinib

R 1:1

Safety and survival
Venetoclax PO for 12 cycles +Obinutuzumab IV for 6 cycles

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
*Zanubrutinib monotherapy, 160 mg BID or 320 mg QD for 3 cycles, followed by sonrotoclax combination therapy for a total of 15 cycles.
Abbreviations: BID, twice daily; CT, computed tomography; CLL, chronic lymphocytic leukemia; CNS, central nervous system; CT/MRI, computed tomography/magnetic
resonance imaging; HRQoL, health-related quality of life; IRC, independent review committee; IV, intravenous; MRI, magnetic resonance imaging; ORR, overall
response rate; OS, overall survival; PFS, progression-free survival; PO, by mouth; QD, once a day; TN, treatment naïve; uMRD, undetectable measurable disease.
REFERENCE: 1. https://www.clinicaltrials.gov/study/NCT06073821. Accessed January 3, 2024.

For more information, contact: medicalinformation@beigene.com

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A Phase 2, Multicenter, Single-Arm Study of Zanubrutinib (BGB-3111)
in Patients With Previously Treated B-Cell Lymphoma Intolerant ofPrior Treatment of Ibrutinib or Acalabrutinib 1
Phase 2BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Enrolling

Study Identiﬁers: BGB-3111-215, NCT04116437
Contact: clinicaltrials@beigene.com

Primary Endpoint: Recurrence and change in severity of treatment-emergent AEs of interest compared with ibrutinib and/or
acalabrutinib-intolerant events within each patient
Key Secondary Endpoints: ORR and PFS by investigator, and PRO

Key Eligibility Criteria

Cohort 1:
intolerant
to ibrutinib
only (n=~50)

Cohort 2:
intolerant toacalabrutinib± ibrutinib(n=up to 40)

Follow-up

Screeningat ≤14 days

• Previously treated CLL/SLL, MCL, MZL, or WM patients intolerant of
ibrutinib and/or acalabrutinib• ≥18 years old• Meet disease criteria for treatment in respective disease prior to initiationof ibrutinib and/or acalabrutinib treatment• Ibrutinib and/or acalabrutinib intolerant in opinion of the investigator• Ibrutinib and/or acalabrutinib toxicities resolved to Grade ≤1 or baseline• No documented disease progression during ibrutinib and/or
acalabrutinib treatment• ECOG PS ≤2• No clinically signiﬁcant cardiovascular disease

Treatment

Study treatment with monotherapy
Zanubrutinib (160 mg BID or 320 mg QD)

Disease progression,unacceptable toxicity,treatment consent
withdrawal, or study
termination

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.

Abbreviations: AE, adverse event; BID, twice daily; CLL, chronic lymphocytic leukemia; ECOG PS, Eastern Cooperative Oncology Group performance status;
MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; ORR, overall response rate; PFS, progression-free survival; PRO, patient reported outcomes;
QD, once a day; SLL, small lymphocytic lymphoma; WM, Waldenström macroglobulinemia.
REFERENCE: 1. Shadman M, Flinn IW, Levy MY, Porter RF, Burke JM, Zafar SF, et al. Zanubrutinib in patients with previously treated B-cell malignancies intolerant of previous
Bruton tyrosine kinase inhibitors in the USA: a phase 2, open-label, single-arm study. Lancet Haematol. 2023;10(1):e35-e45. https://www.ncbi.nlm.nih.gov/pubmed/36400069.
For more information, contact: medicalinformation@beigene.com

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Pivotal Phase 3 Study of Zanubrutinib + Rituximab vs Bendamustine + Rituximab
in Previously Untreated MCL Patients Ineligible for SCT 1,2
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Active, Not Recruiting

Study Identiﬁers: BGB-3111-306, NCT04002297
Contact: clinicaltrials@beigene.com

Primary Endpoint: PFS by IRC
Secondary Endpoints: PFS by investigator, ORR, DOR, OS, Safety

Stratiﬁcation Factors• Histologically conﬁrmed
diagnosis of MCL• Ineligible for SCT(≥70 or 60-69 years old
with comorbidities)• No prior systemic therapy
for MCL• Measurable disease by CT/MRI• Adequate marrow andorgan function• No CNS involvement by MCL• Age: <70 vs ≥70• Region: North America/
Europe and Asia-Paciﬁc• MIPI Score: low vsintermediate/highTreatmentdel(17p)
FISH Test
Screening

Key Eligibility Criteria

Follow-up
Zanubrutinib 160 mg PO BID until PD
Zanubrutinib 160(n=~225)
mg PO BID + Rituximab IV
x 6 cycles followed by Zanubrutinib
monotherapy until PD

R 1:1

Safety and survival
BR x 6 cycles followed byobservation until PD

Zanubrutinib 160 mg PO BID andvenetoclax 400mg daily (n = ~50)

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.

Abbreviations: BID, twice daily; BR, bendamustine and rituximab; CNS, central nervous system; CT/MRI, computed tomography/magnetic resonance imaging;
DOR, duration of response; IRC, independent review committee; MCL, mantle cell lymphoma; MIPI, Mantle cell lymphoma International Prognostic Index;
ORR, overall response rate; OS overall survival; PD, progressive disease; PFS, progression-free survival; PO, by mouth; SCT, stem cell transplantation.
REFERENCES: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002297. Accessed December 1, 2022. 2. Data on ﬁle. BeiGene, Inc.
For more information, contact: medicalinformation@beigene.com

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A Study of Zanubrutinib Versus Lenalidomide in Participants With
Relapsed/Refractory Follicular or Marginal Zone Lymphoma (MAHOGANY)1
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Enrolling

Study Identiﬁers: BGB-3111-308, NCT05100862
Contact: clinicaltrials@beigene.com

Primary Endpoint: PFS by IRC
Key Secondary Endpoints: PFS by investigator, DOR, ORR, CRR by IRC

Key Eligibility Criteria

Follow-up

R 1:1

Cohort 1:
R/R FL

Screening• Histologically conﬁrmed grade 1-3a FL or MZL
requiring systemic therapy• Previously received ≥1 line of systemic therapy
including anti-CD20 agent• Documented failure to achieve at least PR during
or PD after the most recent systemic therapy• Measurable disease by CT or MRI• Adequate bone marrow, liver, and renal function• No transformation to aggressive lymphoma• No clinically signiﬁcant cardiovascular disease

Treatment

Cohort 2:
R/R MZL

Zanubrutinib 160 mg PO BID or 320 mg QD+
Obinutuzumab IV

Lenalidomide PO + Rituximab IV

Safety and survival

R 1:1

Zanubrutinib 160 mg PO BID or 320 mg QD+
Rituximab IV

Lenalidomide PO + Rituximab IV

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.

Abbreviations: BID, twice daily; CD20, cluster of differentiation 20; CRR, complete response rate; CT, computed tomography; DOR, duration of response; FL, follicular lymphoma,
IRC, Independent Review Committee; IV, intravenous; MRI, magnetic resonance imaging; MZL, marginal zone lymphoma; ORR, overall response rate; PD, progressive disease;
PFS, progression-free survival; PO, by mouth; PR, partial response; QD, once a day; R/R, relapsed/refractory.
REFERENCE: 1. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT05100862. Accessed May 1, 2023.

For more information, contact: medicalinformation@beigene.com

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Tislelizumab Monotherapy vs Salvage Chemotherapy for R/R cHL1,2
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Recruiting

Study Identiﬁers: BGB-A317-314, NCT04486391
Contact: clinicaltrials@beigene.com

Key Eligibility Criteria

Treatmentdel(17p)
FISH Test
Screening• Histologically conﬁrmed R/R cHL• Either failed to achieve a response
or progressed after ASCT or
received ≥2 prior lines of systemic
therapy for cHL and was not an
ASCT candidate

Primary Endpoint: PFS by investigator
Key Secondary Endpoints: DOR, ORR, Rate of CR, TTR, OS, Safety

Follow-up
Zanubrutinib 160 mg PO BID until PD(n=~225)
Tislelizumab 200 mg IV Q3W(n=82)

R 2:1
Salvage Chemotherapy(per investigator)(n=41)

Treatment for up
to 45 months or
unacceptable toxicity
or disease progression

Safety and survival

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: ASCT, autologous hematopoietic stem cell transplant; cHL, classical Hodgkin lymphoma; CR, complete response; DOR, duration of response;IV, intravenous; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q3W, every 3 weeks; R/R, relapsed/refractory; TTR, time to response.
REFERENCES: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04486391. Accessed December 1, 2022. 2. Data on ﬁle. BeiGene, Inc.
For more information, contact: medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIO
Liver Cancer
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Zanidatamab(Anti-HER2 bispeciﬁc antibody)

ZWI-ZW25-2031

Worldwide

2L+ HER2+ biliary tract cancer

2

NCT04466891

BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Zymeworks/Jazz collaboration; BeiGene has exclusive development and commercialization rights in Asia (except Japan), Australia, and New Zealand.

1

Abbreviations: 2L, second line; HER2, human epidermal growth factor receptor 2.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIO
Lung Cancer
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Tislelizumab + Chemotherapy

BGB-A317-312

China

1L ES-SCLC

3

NCT04005716

Tislelizumab + Chemotherapy

BGB-A317-315

SchemaChina

Resectable stage II or IIIA NSCLC3

NCT04379635

Tislelizumab + Ociperlimab (Anti-TIGIT)

AdvanTIG-302

SchemaWorldwide

1L PD-L1 high advanced NSCLC3

NCT04746924

Tislelizumab + Ociperlimab(Anti-TIGIT)

BGB-900-105

Worldwide

1L NSCLC dose conﬁrmation

1

NCT04047862

Tislelizumab +/- BGB-A445 (Anti-OX40)+/- LBL-007 (Anti-LAG3) +/- Chemotherapy

BGB-LC-2011

Worldwide

1L advanced, unresectable,
or metastatic NSCLC2

NCT05635708

Tislelizumab +/- Ociperlimab+/- LBL-007

BGB-LC-2021

China

Resectable Stage II/IIIA NSCLC2

NCT05577702

BGB-A445 +/- Tislelizumab +/- Sitravatinib+/- BGB-15025 (HPK1 inhibitor)+/- Chemotherapy

BGB-LC-203

China, S. Korea

NSCLC after anti-PD–L1 therapy

2

NCT06029127

BGB-B3227 (MUC1 x CD16A) +/- Tislelizumab

BGB-B3227-101

Opening soon

Advanced lung cancer

1

NCT06540066

BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Leads Biolabs collaboration; BeiGene has global research, development, and manufacturing rights, and exclusive commercialization rights outside of China.

1

Abbreviations: 1L, ﬁrst line; ES-SCLC, extensive-stage small cell lung cancer; HPK1, hematopoietic progenitor kinase 1; LAG3, lymphocyte-activation gene 3; MUC1, mucin 1;
NSCLC, non-small cell lung cancer; OX40, a member of the tumor necrosis factor (TNF) receptor family, also know as CD134; PD-L1, programmed death-ligand 1;
TIGIT, T cell immunoreceptor with Ig and ITIM domains.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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STUDY DESIGN-315

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Neoadjuvant Treatment
With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo in Combination With Platinum Doublet Chemotherapy Followed by
Adjuvant Tislelizumab or Placebo in Resectable Stage II, IIIA Non-Small Cell Lung Cancer1,2
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Active, not recruiting

STUDY IDENTIFIER: NCT04379635
CONTACT: clinicaltrials@beigene.com

DUAL-PRIMARY ENDPOINTS: MPR by BIPR and EFS by BICRSECONDARY ENDPOINTS: OS, pCR by BIPR, ORR and DFS by BICR, EFS by INV, HRQoL, Safety

KEY ELIGIBILITY

NEOADJUVANT PHASE (3-4 CYCLES)• Resectable Stage II, IIIA NSCLC(plan for R0 resection)• Treatment-naïve
• Exclude EGFR mutation or ALK translocation

STRATIFICATION• Histology (nSQ vs SQ)• Stage (II vs IIIA)R

ADJUVANT PHASE (UP TO 8 CYCLES)

Tislelizumab + Platinum-based
doublet chemotherapy*

Tislelizumab
R0
resection

1:1
Placebo + Platinum-based
doublet chemotherapy*

Placebo

SAFETY/SURVIVAL FOLLOW-UP

Continue assessment until

Until:• Local/distant recurrence• Death• Unacceptable AE• EOS*The following platinum-based doublet chemotherapy options are permitted:- Cisplatin or carboplatin + pemetrexed for nSQ- Cisplatin or carboplatin + paclitaxel for SQ• PD-L1 expression (≥1% vs <1%/not
evaluable/indeterminate)

For more information, contact: medicalinformation@beigene.com
The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
Abbreviations: AE, adverse event; ALK, anaplastic lymphoma kinase; BICR, blinded independent central review; BIPR, blinded independent pathology review; DFS, disease-free survival; EFS, event-free survival; EGFR, epidermal growth factor receptor; EOS, end of study; HRQoL, health-related quality of life;
INV, investigator; MPR, major pathological response; NSCLC, non-small cell lung cancer; nSQ, non-squamous; ORR, objective response rate; OS, overall survival; pCR, pathological complete response; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; SQ, squamous.
REFERENCES: 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04379635. Accessed December 1, 2022. 2. Data on file. BeiGene, Inc.

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Ociperlimab in Combination With Tislelizumab vs Pembrolizumab in 1L,
PD-L1-Selected, Locally Advanced, Unresectable, or Metastatic NSCLC1,2
Phase 3BLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Active, Not Recruiting

Study Identiﬁer: AdvanTIG-302, NCT04746924
Contact: clinicaltrials@beigene.com

Primary Endpoints: OS between Arm A and Arm B
Key Secondary Endpoints: PFS,* ORR,* DOR,* HRQoL, TDD, Safety

Key Eligibility Criteria• Metastatic non-squamous or squamous NSCLC, or locallyadvanced or recurrent NSCLC that is not eligible forcurative surgery and/or deﬁnitive radiotherapy with orwithout chemoradiotherapy• Tumor cell PD-L1 expression ≥50%†

Treatment

Follow-up

Ociperlimab 900 mg IV Q3W+ Tislelizumab 200 mg IV Q3W(n=275)
R 5:5:1• No known EGFR, BRAF (V600E), ROS1 mutations, or
ALK rearrangements• No prior systemic treatment for metastatic NSCLC• No prior checkpoint inhibitor treatment

Pembrolizumab 200 mg IV Q3W+ placebo IV Q3W(n=275)Tislelizumab 200 mg IV Q3W+ placebo IV Q3W(N=55)

Treatment
until diseaseprogression,
intolerable
toxicity, orwithdrawal forother reasons

Safety and survival

The study above may relate to investigational products or investigational uses of an approved product that have not yet been approved.
*By investigator, †Determined centrally by VENTANA PD-L1 [SP263] assay.
Abbreviations: 1L, ﬁrst line; ALK, anaplastic lymphoma kinase; DOR, duration of response; EGFR, epidermal growth factor receptor; HRQoL, health-related quality of life; IV, intravenous; NSCLC, non-small cell lungcancer; ORR, objective response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; Q3W, every 3 weeks; TDD, time to deterioration.
REFERENCES: 1. Socinski MA, Spira AI, Paz-Ares LG. AdvanTIG-302: Anti-TIGIT monoclonal antibody (mAb) ociperlimab (OCI) plus tislelizumab (TIS) vs pembrolizumab (PEM) in
programmed death ligand 1 (PD-L1) selected, previously untreated, locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC). Presented at: 2021 American Societyof Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021; Virtual. 2. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04746924. Accessed December 1, 2022.

For more information, contact: medicalinformation@beigene.com

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SOLID TUMORSFor more information, contact: medicalinformation@beigene.com

1019-BGB-A333-MRC-005 August 2024

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Gynecologic Oncology
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Pamiparib (PARP 1/2 inhibitor)

BGB-290-302

China

2L/3L maintenanceplatinum-sensitive OC

3

NCT03519230

Abbreviations: 2L, second line; 3L, third line; OC, ovarian cancer; PARP, poly-ADP ribose polymerase.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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SOLID TUMORSFor more information, contact: medicalinformation@beigene.com

1019-BGB-A333-MRC-005 August 2024

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Solid Tumors
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

BGB-43395 (CDK4 inhibitor) +/fulvestrant +/- letrozole

BGB-43395-101

Worldwide

HR+/HER2- advanced solid tumors

1

NCT06120283

BGB-43395 +/- fulvestrant+/- letrozole

BGB-43395-102

China

HR+/HER2- advanced solid tumors

1

NCT06253195

BG-68501 (CDK2 inhibitor) +/fulvestrant

BGB-68501-1011

Australia,
United States

Advanced solid tumors

1

NCT06257264

BGB-24714 (SMAC mimetic)+/- Chemotherapy

BGB-24714-101

Worldwide

Advanced solid tumors

1

NCT05381909

BGB-A317-26808-101

Worldwide

Advanced solid tumors

1

NCT05981703

BGB-A317-30813-101

Worldwide

Advanced or metastatic solid tumors

1

NCT05904496

BGB-A317-A3055-101

Worldwide

Select advanced or metastatic
solid tumors

1

NCT05935098

BGB-A317-A445-201

China

Select advanced solid tumors

1/2

NCT05661955

BGB-26808 (HPK1 inhibitor) +/Tislelizumab (anti-PD-1)
BGB-30813 (DGKζ inhibitor)+/- Tislelizumab
BGB-A3055 (anti-CCR8) +/Tislelizumab
BGB-A445 (Anti-OX40) +/Tislelizumab

PAGE 1 of 2
1

Ensem collaboration; BeiGene has global rights.

Abbreviations: CCR8, C-C chemokine receptor 8; CDK2, cyclin-dependent kinase 2; CDK4, cyclin-dependent kinase 4; DGKζ, diacylglycerol kinase zeta; HER2, human epidermal growth factor receptor 2;
HPK1, hematopoietic progenitor kinase 1; HR, hormone receptor; OX40, a member of the tumor necrosis factor (TNF) receptor family, also know as CD134; PD-1, programmed cell death protein 1;
SMAC, second mitochondrial-derived activator of caspases.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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SOLID TUMORSFor more information, contact: medicalinformation@beigene.com

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INVESTIGATIONAL CLINICAL PORTFOLIOBLADDER

BREASTGASTROINTESTINAL

HEAD AND NECK

HEMATOLOGICMALIGNANCIES

LIVER

LUNG

GYNECOLOGICONCOLOGY

Solid Tumors
Investigational
Medicinal Product

Study

Geography

Disease Area of Research

Phase

Registry Number

Tislelizumab + BGB-15025(HPK1 Inhibitor)

BGB-A317-15025-101

Worldwide

Advanced solid tumors

1

NCT04649385

BG-C9074 (B7H4 ADC) +/Tislelizumab

BG-C9074-1011

Australia,
United States

Advanced solid tumors

1

NCT06233942

BGB-C354 (B7H3 ADC) +/Tislelizumab

BGB-C354-101

Opening soon

Advanced solid tumors

1

NCT06422520

BGB-B2033 (GPC3 x 4-1BB) +/Tislelizumab

BGG-B2033-101

Opening soon

Select advanced or metastatic
solid tumors

1

NCT06427941

BGB-R046 (IL-15 prodrug) +/Tislelizumab

BGB-R046-101

China

Advanced solid tumors

1

NCT06487858

PAGE 2 of 2
DualityBio collaboration; BeiGene has global clinical, manufacturing, and commercialization rights.

1

Abbreviations: ADC, antibody drug conjugate; GPC3, glypican-3; HPK1, hematopoietic progenitor kinase 1; IL-15, interleukin-15.
The studies above may relate to investigational products or investigational uses of approved products that have not yet been approvedby the applicable regulatory agency in your country or region. For more information contact medicalinformation@beigene.com

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1019-BGB-A333-MRC-005 August 2024