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

AdvanTIG-105: a phase I/Ib dose-expansion study of ociperlimab plus tislelizumab with or without chemotherapy in metastatic non-small cell lung cancer and extensive-stage small cell lung cancer. (PubMed, J Immunother Cancer) - P1 | "Ociperlimab and tislelizumab±chemotherapy demonstrated a manageable safety profile and preliminary antitumor activity in patients with NSCLC or ES-SCLC. Findings from this small phase I study should be interpreted with caution."

Journal • P1 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

AdvanTIG-302: Phase 3 Study of Ociperlimab (Anti-TIGIT) + Tislelizumab (Anti-PD-1) Versus Pembrolizumab in Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥50. (PubMed, J Thorac Oncol) - P3 | "Ociperlimab plus tislelizumab showed no improvement in OS versus pembrolizumab; median OS was comparable across arms. Data for B versus C should be interpreted cautiously given the descriptive nature of this comparison. The safety profiles of all treatment arms were well-tolerated with no new safety signals."

Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • 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

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

AdvanTIG-206: Phase II randomized open-label study of ociperlimab (OCI) + tislelizumab (TIS) + BAT1706 (bevacizumab biosimilar) versus TIS + BAT1706 in patients (pts) with advanced hepatocellular carcinoma (HCC) (ESMO 2023) - P2 | "No new safety signals were identified in either arm. The OS data are premature and need further follow-up."

Clinical • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • TIGIT

AdvanTIG-301: a phase III study of ociperlimab plus tislelizumab and concurrent chemoradiotherapy in stage III unresectable non-small cell lung cancer. (PubMed, J Immunother Cancer) - P3 | "There was a trend toward improved efficacy when adding tislelizumab with or without ociperlimab to cCRT followed by tislelizumab with or without ociperlimab compared with cCRT followed by durvalumab; however, efficacy data were for descriptive purposes only. No unexpected or new safety signals were identified."

Clinical • IO biomarker • Journal • P3 data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1

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. (ASCO 2026) - P1 | "Pts with NSCLC with PD-L1 ≥25%, TIGIT ≥5%, or PD-L1/TIGIT double high can achieve a trend toward longer PFS and higher ORR than PD-L1 low or TIGIT low subgroups when treated with OCI plus TIS. Longer PFS in PD-L1 ≥25% or TIGIT ≥5% subgroups in NSQ- vs SQ-NSCLC may be associated with biological differences in histology. Confirmation of these results will require prospective evaluation of OCI plus TIS in randomized studies."

Biomarker • Clinical • IO biomarker • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung 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=404 | Completed | Sponsor: BeOne Medicines | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

AdvanTIG-302: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer (clinicaltrials.gov) - P3 | N=669 | Terminated | Sponsor: BeiGene | Active, not recruiting ➔ Terminated; This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns.

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

AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma. (PubMed, Cancer Immunol Immunother) - P2 | "In patients with advanced HCC, tislelizumab plus BAT1706 demonstrated promising ORR, while adding ociperlimab was not associated with improved efficacy. The safety profile of ociperlimab and tislelizumab plus BAT1706 was tolerable and manageable, with no new safety signals identified."

Clinical • Journal • P2 data • Hepatocellular Cancer • Oncology • Solid Tumor

AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC) (AACR 2024) - P2 | "In patients with untreated limited-stage SCLC, tislelizumab + cCRT yielded a trend of improvement in PFS and ORR vs cCRT; addition of ociperlimab did not show detectable improvement. The overall safety profile of the treatments was tolerable, manageable, and generally consistent with the known risks of ociperlimab, tislelizumab, and cCRT."

Clinical • IO biomarker • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1 • TIGIT

Exploration of potential biomarkers correlated with efficacy of ociperlimab (anti-TIGIT) plus tislelizumab (anti-PD-1) in 1L PD-L1+ non-small cell lung cancer (NSCLC) (AACR 2024) - P1 | "Anti-TIGIT MOA-related genes and signatures correlated with efficacy in ociperlimab + tislelizumab-treated 1L PD-L1+ NSCLC. Combining anti-TIGIT MOA-related factors with PD-L1 expression identified a subgroup of patients with improved efficacy.Table. Efficacy Analyses in Patient SubgroupsCutoff: aTop 1/3; bMedian; cTC≥25%"

Biomarker • Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCR8 • CD226 • PD-L1 • TIGIT

BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: BeOne Medicines | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

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: BeOne Medicines | Trial completion date: Dec 2026 ➔ Jul 2026 | Trial primary completion date: Dec 2026 ➔ Jul 2026

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

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) - P3 | "Data should be interpreted cautiously given the descriptive nature of this comparison. The safety profiles of all treatment arms were well tolerated with no new safety signals.Editorial acknowledgement Medical writing support was provided by Lee Blackburn, MSc, of AMICULUM, and supported by BeOne Medicines."

Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

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 [WITHDRAWN] (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 SCLC. (PubMed, JTO Clin Res Rep) - P2 | "Ociperlimab and tislelizumab plus cCRT and tislelizumab plus cCRT exhibited a trend for improvement in PFS and numerically higher objective response rate compared with cCRT, with no new safety signals beyond the known profiles of immune checkpoint inhibitors and cCRT. Adding ociperlimab to tislelizumab plus cCRT was not associated with additional improvement in efficacy."

Journal • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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 (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