BGB-A445 / BeOne Medicines - LARVOL DELTA

A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=113 | Active, not recruiting | Sponsor: BeiGene | N=202 ➔ 113 | Trial primary completion date: Oct 2026 ➔ May 2025

Enrollment change • Trial primary completion date • Genito-urinary Cancer • Melanoma • Mucosal Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

A phase I study of the OX40 agonist BGB-A445 with or without tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumors: dose-escalation results. (PubMed, Cancer Chemother Pharmacol) - P1 | "BGB-A445 was well tolerated and demonstrated on-target immune activation at clinically relevant doses. Antitumor activity was observed across cohorts."

Journal • P1 data • Oncology • Solid Tumor

BGB-A317-A445-101: Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=204 | Completed | Sponsor: BeiGene | Phase classification: P2 ➔ P1

Phase classification • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A phase 2 study of the OX40 agonist BGB-A445, in combination with docetaxel or BGB-15025, an HPK1 inhibitor, in patients with NSCLC pretreated by anti-PD-(L)1 antibodies. (ASCO 2025) - P2 | "BGB-A445 plus docetaxel or BGB-15025 was generally well tolerated in pts with advanced NSCLC and showed limited antitumor activity. SafetyPts with multiple AEs are counted once. All AEs are n (%)."

Clinical • Combination therapy • IO biomarker • P2 data • Cardiovascular • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma

A phase 1 study of the OX40 agonist BGB-A445, with or without tislelizumab, an anti-PD-1 monoclonal antibody, in patients with advanced NSCLC, HNSCC, or NPC. (ASCO 2025) - P2 | "BGB-A445 alone or in combination with tislelizumab and chemotherapy was generally well tolerated across all doses in pts with advanced NSCLC, HNSCC, and NPC, and showed preliminary antitumor activity. Safety.Pts with multiple adverse events (AEs) are counted once. All AEs are listed as n (%)."

Clinical • Metastases • P1 data • Anemia • Febrile Neutropenia • Head and Neck Cancer • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BeiGene Presents Pioneering Cancer Research at ASCO 2025 – Redefining Treatment Across Hematology and Solid Tumors (Businesswire) - "BeiGene, Ltd...announced it will share 23 abstracts featuring new data across its hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, May 30 – June 3, 2025. With two abstracts selected for rapid oral presentation, these data reflect the Company’s vision to address cancer across multiple fronts and provide innovative medicines to as many patients as possible worldwide."

Clinical data • Chronic Lymphocytic Leukemia • Esophageal Squamous Cell Carcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Small Lymphocytic Lymphoma • Squamous Cell Carcinoma of Head and Neck

BGB-LC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: BeiGene | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • 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

A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=202 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2026 ➔ Oct 2026

Enrollment closed • Trial primary completion date • Genito-urinary Cancer • Melanoma • Mucosal Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

BGB-A317-A445-101: Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=204 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed | N=342 ➔ 204

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

BGB-LC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-A445-101: Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=342 | Active, not recruiting | Sponsor: BeiGene | Phase classification: P1 ➔ P2

Combination therapy • Metastases • Phase classification • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | N=100 ➔ 35 | Trial completion date: May 2026 ➔ Dec 2024 | Trial primary completion date: Jan 2026 ➔ Dec 2024

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-A445-101: Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=342 | Active, not recruiting | Sponsor: BeiGene | N=203 ➔ 342

Combination therapy • Enrollment change • Metastases • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=202 | Recruiting | Sponsor: BeiGene | Trial completion date: Aug 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2024 ➔ Apr 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Melanoma • Mucosal Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

BeiGene Enters Next Phase of Global Growth with Announcement of Second Quarter 2024 Financial Results and Corporate Updates (Businesswire) - "BGB-16673 (BTK CDAC): Anticipating first subject enrolled in Phase 3 program in fourth quarter of 2024 or first quarter of 2025....Multiple randomized tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024....Pan-KRAS, MTA-cooperative PRMT5 inhibitors and EGFR CDAC targeted protein degrader on track to enter the clinic in the second half of 2024."

Clinical data • New P3 trial • New trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

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

A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: BeiGene | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Metastases • Phase classification • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

BeiGene Reports First Quarter 2024 Financial Results and Business Updates (Businesswire) - "Gastrointestinal Cancers: Multiple tislelizumab combination cohorts with LBL-007 (anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024; Plan to submit a BLA with the NMPA for zanidatamab for the treatment of second-line biliary tract cancer; and CEA-ADC and FGFR2b-ADC on track to enter the clinic in the second half of 2024."

New trial • Non-US regulatory • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

BeiGene Reports First Quarter 2024 Financial Results and Business Updates (Businesswire) - "Enrolled last subject in a Phase 3 clinical trial for ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC; Multiple tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024; and Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on track to enter the clinic in the second half of 2024."

Clinical data • New trial • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-LC-201 (NCT05635708): A phase 2, open-label, multi-arm study of tislelizumab (TIS; anti-PD-1) in combination with investigational agents +/- chemotherapy as first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) (AACR 2024) - P2 | "This phase 2 study will determine whether adding investigational agents BGB-A445 (OX40 agonistic monoclonal antibody [mAb]), LBL-007 (anti-lymphocyte activation gene-3 mAb), or BGB-15025 (hematopoietic progenitor kinase 1 [HPK1] inhibitor) improves the therapeutic benefit of TIS (anti-PD-1 mAb) +/- chemo in patients with locally advanced, unresectable, or metastatic NSCLC. The umbrella design allows for the use of multiple investigational drugs, administered alone or in combination, in patients with untreated locally advanced, unresectable, or metastatic NSCLC without actionable driver mutations. Exploratory endpoints include overall survival, time to response, and relevant biomarker associations with response or resistance to study treatments. Enrollment is ongoing at 66 sites in China, Asia-Pacific, the United States, and the European Union."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BGB-A317-A445-101: Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=203 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Sep 2024 | Trial primary completion date: May 2025 ➔ Sep 2024

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

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: BeiGene | N=200 ➔ 400

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor