ociperlimab (BGB-A1217) / BeOne Medicines - LARVOL DELTA

AdvanTIG-302: Phase 3 Study of Ociperlimab (OCI) + Tislelizumab (TIS) Versus Pembrolizumab (PEM) in Programmed Death-Ligand 1 (PD-L1) High, Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC) (ESMO-IO 2025) - No abstract available

Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Exploratory Biomarker Analysis of Ociperlimab (OCI) Plus Tislelizumab (TIS) in Patients (Pts) with PD-L1-Positive Non-Small Cell Lung Cancer (NSCLC) in AdvanTIG-105 (ESMO-IO 2025) - No abstract available

Biomarker • Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

AdvanTIG-204: A Phase 2, Randomized, Open-Label Study of Ociperlimab Plus Tislelizumab and Concurrent Chemoradiotherapy Versus Tislelizumab and Concurrent Chemotherapy Versus Concurrent Chemoradiotherapy in First-Line Limited-Stage Small-Cell Lung Cancer (JTO Clinical and Research Reports) - "126 patients were randomized to Arms A (N = 41), B (N = 42) and C (N = 43). Median PFS [95% CI] showed a trend for improvement in Arms A (12.6 [8.7–NE] months) and B (13.2 [8.5–NE]) compared with C (9.5 [8.3–14.4]); PFS benefit was comparable between Arms A and B. Objective response rate (ORR), complete response rate and median duration of response were numerically higher in Arms A and B than in C."

P2 data • Small Cell Lung Cancer

The Mechanism of Immunotherapeutic Resistance in Pulmonary Sarcomatoid Carcinoma (IASLC-WCLC 2025) - "Experimental mice were divided into four groups, with the exposure of following drugs: IPG1576 (MIF inhibitor; 10 mg/kg, i.p., q2d), BX471 (CCR1 antagonist; 50 mg/kg, s.c., q2d), Camrelizumab, Ociperlimab and Maraviroc [CCR5 antagonist] (all 10 mg/kg, i.p., q3d). In humanized PDX models (Fig.1M), the CCR1/CCR5 inhibitor combination (G4) outperformed MIF inhibitor/ anti-TIGIT (G3) (Figs.1O-P), reversing resistance by increasing precursor-exhausted and reducing terminal-exhausted CD8+ T cells (Fig.1Q). These findings identify CCR1/CCR5 blockade as a novel strategy to reverse immunotherapeutic resistance in PSC Conclusions : The additional combination of CCR1/CCR5 blockade with anti-PD-1 demonstrated a synergistic efficacy to immunotherapy-resistant tumors via reshaping the microenvironment, potentially offering a novel approach to combat immunotherapy resistance in PSC."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • CCL3 • CD8 • CXCL10 • CXCL5 • GZMK • LDHB • NECTIN2 • SLC8A1 • TIGIT

A Phase 2 Multicenter Umbrella Trial Assessing Tislelizumab ± Anti-TIGIT or Anti-LAG-3 mAb ± Chemotherapy in Resectable NSCLC (IASLC-WCLC 2025) - P2 | "Patients with PD-L1 TC ≥50% were assigned to Substudy 1 and randomized to TIS (anti-PD-1; Arm 1A), TIS plus ociperlimab (anti-TIGIT; Arm 1B), or TIS plus LBL-007 (anti-LAG-3; Arm 1C); patients with PD-L1 TC <50% were assigned to Substudy 2 and randomized to TIS and chemotherapy (Arm 2A) or TIS plus LBL-007 and chemotherapy (Arm 2C). Conclusions : Neoadjuvant TIS as monotherapy or TIS-based immunotherapy combinations in PD-L1 TC ≥50% NSCLC had promising MPR/pCR; the addition of other immunotherapy to neoadjuvant TIS and chemotherapy in PD-L1 TC <50% did not provide additional efficacy benefit. Treatment guided by histology and PD-L1 expression is suggested for future exploration."

Clinical • IO biomarker • P2 data • Anemia • Hematological Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • TIGIT

First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study. (PubMed, Signal Transduct Target Ther) - P2 | "Treatment-related adverse events of grade ≥3 occurred in 60.0% of patients; immune-mediated adverse events of any grade was observed in 42.2%, with the majority being grade 1 or 2. In conclusion, first-line tislelizumab and ociperlimab plus GemCis yielded clinically promising tumor response and survival outcomes in advanced BTC and were generally well tolerated without new safety signals."

Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • TIGIT

First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study (Nature, Sig Transduct Target Ther) - "Among the 41 patients in the efficacy analysis set, the confirmed ORR was 51.2% (95% CI 35.1–67.1), achieving the statistical superiority criteria (p = 0.0003)....After a median follow-up of 14.6 months, median progression-free survival was 7.7 months (95% CI 6.0–9.4), with a median overall survival of 17.4 months (95% CI 11.7-not reached)."

P2 data • Biliary Tract Cancer

First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study (Nature, Sig Transduct Target Ther) - "Among the 41 patients in the efficacy analysis set, the confirmed ORR was 51.2% (95% CI 35.1–67.1), achieving the statistical superiority criteria (p = 0.0003)....After a median follow-up of 14.6 months, median progression-free survival was 7.7 months (95% CI 6.0–9.4), with a median overall survival of 17.4 months (95% CI 11.7-not reached)."

P2 data • Biliary Tract Cancer

ADVANTIG-101: A PHASE 1B/2 STUDY OF OCIPERLIMAB (ANTI-TIGIT) PLUS TISLELIZUMAB (ANTI-PD-1) OR RITUXIMAB IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (ICML 2025) - P1/2 | "OCI + TIS or ritux showed acceptable safety and tolerability in R/R DLBCL. Limited antitumor activity was observed; additional combination strategy with selected biomarkers may be explored to expand this benefit."

IO biomarker • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-L1 • TIGIT

AdvanTIG-302: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer (clinicaltrials.gov) - P3 | N=662 | Active, not recruiting | Sponsor: BeiGene | Trial completion date: Feb 2027 ➔ Mar 2026 | Trial primary completion date: Oct 2026 ➔ May 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

ADVANTIG-101: A PHASE 1B/2 STUDY OF OCIPERLIMAB (ANTI-TIGIT) PLUS TISLELIZUMAB (ANTI-PD-1) OR RITUXIMAB IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (EHA 2025) - P1/2 | "OCI + TIS or OCI + ritux showed acceptable safety and tolerability in R/R DLBCL. Limited antitumor activity was observed; additional combination strategy with selected biomarkers may be explored to expand this benefit."

IO biomarker • P1/2 data • Anemia • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Diffuse Large B Cell Lymphoma • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hematological Malignancies • Interstitial Lung Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1 • TIGIT

AdvanTIG-202: Phase 2 open-label, two-cohort multicenter study of ociperlimab plus tislelizumab and tislelizumab alone in patients with previously treated recurrent or metastatic cervical cancer. (PubMed, Gynecol Oncol) - P2 | "In patients with R/M CC who had received prior chemotherapy, ociperlimab + tislelizumab has promising antitumor activity in both all-comers and PD-L1+ subgroup, supporting further investigation of immune-modulating agent combinations for R/M CC."

Clinical • Journal • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

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

BeiGene Provides Update on the Ociperlimab (BGB-A1217) Clinical Development Program (Businesswire) - "BeiGene...today announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. The Independent Data Monitoring Committee recommended terminating the ongoing Phase 3 AdvanTIG-302 trial (NCT04746924) based on its findings as part of a pre-planned futility analysis. The overall efficacy and safety data assessment suggested that the study was unlikely to meet the primary endpoint of overall survival. No new safety signals were observed. After thorough deliberation, the Company has made the decision to terminate the trial....Results from this study will be shared at a later date to help advance science and the understanding of anti-TIGIT activity."

Discontinued • DSMB • Trial termination • Lung Cancer • Non Small Cell Lung Cancer

BGB-LC-202: Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=121 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jan 2025 | Trial primary completion date: Dec 2026 ➔ Jan 2025

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

The TERRIFIC Trail: The efficacy and safety of Tislelizumab combined with Ociperlimab and chemotherapy in the perioperative treatment of resectable esophageal squamous cell carcinoma: a single arm phase II study (ChiCTR) - P2 | N=140 | Recruiting | Sponsor: Drum Tower Hospital; Drum Tower Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

BGB-LC-202: Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=121 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

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

Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB A1217) in Combination With Tislelizumab (BGB A317) or Rituximab (clinicaltrials.gov) - P1/2 | N=53 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Aug 2024

Trial completion • Trial completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-L1

AdvanTIG-205: Ociperlimab with Tislelizumab and Chemotherapy in Participants with Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=272 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

AdvanTIG-302: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer (clinicaltrials.gov) - P3 | N=662 | Active, not recruiting | Sponsor: BeiGene | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Apr 2026 ➔ Oct 2026

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

AdvanTIG-105: Study of Ociperlimab (BGB-A1217) in Combination with Tislelizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=449 | Completed | Sponsor: BeiGene | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

BeiGene Announces First Patient Dosed in Global Phase 3 Trial of Anti-TIGIT Antibody Ociperlimab in Non-Small Cell Lung Cancer (Businesswire) - “BeiGene, Ltd…announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene’s investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations.”

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB A1217) in Combination With Tislelizumab (BGB A317) or Rituximab (clinicaltrials.gov) - P1/2 | N=53 | Active, not recruiting | Sponsor: BeiGene | N=80 ➔ 53 | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-L1

AdvanTIG-302: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer (clinicaltrials.gov) - P3 | N=662 | Active, not recruiting | Sponsor: BeiGene | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • 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=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