surzebiclimab (BGB-A425) / BeOne Medicines - LARVOL DELTA

BGB-HNSCC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: BeiGene | Trial completion date: Jan 2027 ➔ May 2026 | Trial primary completion date: Jan 2027 ➔ Jun 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=430 | Enrolling by invitation | Sponsor: BeiGene | N=300 ➔ 430

Enrollment change • Oncology • Solid Tumor

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=114 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=114 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | N=358 ➔ 114

Enrollment change • Enrollment closed • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-HNSCC-201: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination with Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=358 | Recruiting | Sponsor: BeiGene | Trial completion date: Dec 2027 ➔ Apr 2025 | Trial primary completion date: Mar 2026 ➔ Apr 2025

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=300 | Enrolling by invitation | Sponsor: BeiGene | Trial completion date: Aug 2024 ➔ Dec 2026 | Trial primary completion date: Aug 2024 ➔ Dec 2026

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Translational assessment of triple combination with Tislelizumab (anti-PD-1), LBL-007 (anti-LAG-3) and Surzebiclimab (anti-TIM-3) highlights its strong anti-tumor activity and clinical potential in solid tumors such as HNSCC (AACR 2024) - P2 | "The concurrent blockade of PD-1/LAG-3/TIM-3 represents a promising strategy to enhance T cell function and anti-tumor activity. The results demonstrated the therapeutic potential of the triple combination. A Ph2 study evaluating Tisle in combination with LBL-007 and/or Surze in first-line treatment of recurrent or metastatic HNSCC (NCT05909904) is recruiting."

Clinical • IO biomarker • Colon Cancer • Colorectal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IFNG

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024 (Businesswire) - "An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors. BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673....An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab)..."

Preclinical • Head and Neck Cancer • Hematological Malignancies • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BGB-HNSCC-201: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: BeiGene

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

BGB-HNSCC-201 (NCT05909904): Phase 2, Open-Label, Multi-Arm, Global Study of Tislelizumab (TIS) + Investigational Agents as First-Line (1L) Treatment in Patients (Pts) With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (ESMO-IO 2023) - P2 | "Anti-programmed cell death-protein 1 (PD-1) therapy, either alone or in combination with chemotherapy (CT), extended overall survival (OS) vs cetuximab + CT in pts with programmed cell death-ligand 1 (PD-L1)-positive R/M HNSCC in the 1L setting; however, not all pts respond to single-agent anti-PD-1 therapy...This Phase 2 study will assess efficacy and safety of TIS in combination with investigational agents targeting the immune-checkpoint inhibitors TIM-3 (BGB-A425) and/or LAG-3 (LBL-007) as 1L treatment in pts with R/M HNSCC...Secondary endpoints include progression-free survival, duration of response, clinical benefit rate, and disease control rate (all per investigator; RECIST v1.1) as well as safety, OS, and immunogenicity to study drugs. Enrollment is ongoing and additional experimental arms may be added in the future."

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • HAVCR2 • LAG3

Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: BeiGene

Combination therapy • Metastases • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

[VIRTUAL] Bgb-A425, an investigational anti-TIM-3 monoclonal antibody, in combination with tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors: A phase I/II trial in progress. (ASCO 2020) - P1/2 | "Safety/tolerability profile and RP2D determination (phase 1) and objective response rate per RECIST v1.1 (phase 2) are primary objectives; secondary objectives include antitumor activity, PK profile, and immunogenicity of combination therapy. Research Funding: BeiGene, Ltd."

Clinical • Combination therapy • IO biomarker • P1/2 data • Immune Modulation • Inflammation • Oncology • Solid Tumor

BGB-900-102: Study of BGB-A425 and LBL-007 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=358 | Recruiting | Sponsor: BeiGene | N=162 ➔ 358 | Trial completion date: Jan 2024 ➔ Dec 2027 | Trial primary completion date: Jul 2023 ➔ Mar 2026

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BeiGene Reports Second Quarter 2022 Financial Results (Businesswire) - "Expected Milestones-Early Stage Programs: In collaboration with Leads Biolabs, initiate patient dosing of LBL-007, a novel investigational antibody targeting the LAG-3 pathway, in combination with tislelizumab and surzebiclimab (TIM3) in 2022."

New trial • Oncology

Changing Practice in NSCLC: Should We Optimize Immunotherapy Responses, Novel Drug Delivery Mechanisms, or Both? (ASCO Daily News) - "TIM-3 is an inhibitory receptor that is expressed on T cells and myeloid cells, and its overexpression is associated with T-cell exhaustion and myeloid cell activation. The expression of TIM-3 on T cells is associated with a worse prognosis among patients with melanoma."

Media quote

Study of BGB-A425 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=162; Recruiting; Sponsor: BeiGene; Trial completion date: Sep 2023 ➔ Jan 2024; Trial primary completion date: Mar 2023 ➔ Jul 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BeiGene Reports Second Quarter 2021 Financial Results (Businesswire) - "BRUKINSA® (zanubrutinib): Completed enrollment in the Phase 2 global ROSEWOOD trial (NCT03332017) in combination with obinutuzumab versus obinutuzumab alone in patients with R/R follicular lymphoma....Expected Milestones for BRUKINSA: Report additional results from the Phase 3 ALPINE trial (NCT03734016) in 2022. Expected Milestones for Tislelizumab: Submit an sBLA to the CDE of tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC in 2021. Expected Milestones for Early-Stage Programs: Initiate the Phase 2 portion of the Phase 1/2 trial (NCT03744468) of BGB-A425 (an investigational TIM3 monoclonal antibody) in combination with tislelizumab in the second half of 2021....Sitravatinib: Initiated patient enrollment in the Phase 3 trial (NCT04921358) of sitravatinib in combination with tislelizumab in squamous and non-squamous NSCLC."

Enrollment status • P3 data • sBLA • Trial status • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor

Study of BGB-A425 in Combination With Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=162; Recruiting; Sponsor: BeiGene; Trial completion date: Dec 2021 ➔ Sep 2023; Trial primary completion date: Jun 2021 ➔ Mar 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BeiGene Reports First Quarter 2021 Financial Results (Businesswire) - "Initiate a Phase 1 trial (NCT04771130) for BGB-11417, BeiGene’s investigational BCL-2 inhibitor, in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in 2021. BGB-11417 has been designed to be a potent and selective small molecule Bcl-2 inhibitor; and Initiate the Phase 2 portion of the Phase 1/2 trial (NCT03744468) of BGB-A425 in the first half of 2021....Initiate a Phase 3 trial of sitravatinib in combination with tislelizumab in squamous and non-squamous NSCLC in 2021."

Enrollment status • New P3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Non Small Cell Lung Cancer • Oncology

BeiGene Reports Fourth Quarter and Full Year 2020 Financial Results (Businesswire) - "Initiate the Phase 2 portion of the Phase 1/2 trial (NCT03744468) of BGB-A425 in the first half of 2021."

Enrollment status • Oncology • Solid Tumor