AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)

The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥10], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.

Start Date15 Sep 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05791097

/ WithdrawnPhase 3

AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

Start Date28 Jul 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05577702

/ CompletedPhase 2

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery.

Start Date08 Mar 2023

Sponsor / Collaborator

BeOne Medicines Ltd.

100 Clinical Results associated with Ociperlimab

100 Translational Medicine associated with Ociperlimab

100 Patents (Medical) associated with Ociperlimab

Literatures (Medical) associated with Ociperlimab

01 Jul 2026·Journal of Thoracic Oncology

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%

Article

Author: Arulananda, Surein ; Tan, Wei ; Li, Xingya ; Spira, Alexander I ; Paz-Ares, Luis ; Martinez-Bueno, Alejandro ; Socinski, Mark A ; Zhou, Jincheng ; Nishio, Makoto ; Lu, Shun ; Reck, Martin ; Zeng, Aiping ; Melkadze, Tamar ; Yu, Xinmin ; Chica-Duque, Sandra ; Zuo, Yunxia ; Dai, Wanjun

INTRODUCTION:

Novel agents that improve outcomes in non-small cell lung cancer (NSCLC) are needed. Co-inhibition of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitor motif domains and programmed cell death protein-1 (PD-1) may enhance anti-PD-1 activity. AdvanTIG-302 is a phase 3 trial of ociperlimab plus tislelizumab (A), pembrolizumab (B), and tislelizumab (C) in first-line stage III/IV NSCLC with PD-L1 ≥50% (NCT04746924).

METHODS:

Eligible patients were randomized (5:5:2) to A, B, or C.

PRIMARY OBJECTIVE:

overall survival (OS) in A versus B; key secondary analyses: progression-free survival (PFS) and overall response rate (ORR).

RESULTS:

As of May 30, 2025, the prespecified interim analysis (N=662) was terminated due to futility; efficacy analyses are descriptive only. Median OS (95% CI) was 31.9 (25.7-not estimable [NE]), 29.4 (25.8-35.0), and 27.7 (20.0-NE) months for Arms A, B and C, respectively; stratified hazard ratio for A vs B was 0.97 (95% CI: 0.76-1.23). For A, B, and C, respectively, median PFS (95% CI) was 14.3 (11.5-16.0), 10.5 (8.4-12.6), and 16.6 (8.9-26.3) months, and ORR (95% CI) was 61.0% (55.1-66.7), 48.8% (42.9-54.7), and 55.7% (44.7-66.3). In A, B, and C, treatment-related adverse events occurred in 84.3%, 79.4%, and 79.3% of patients, respectively.

CONCLUSION:

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.

01 Nov 2025·JTO clinical and research reports

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

Article

Author: Gao, Yujuan ; Cheng, Yufeng ; Wu, Hongbo ; Yoo, Seung Soo ; Lu, You ; Bao, Zinan ; Sun, Pu ; Gong, Youling ; Zhu, Zhengfei ; Yu, Rong ; Huang, Jiangqiong ; Zhong, Diansheng ; Pang, Qingsong ; Dobbs, Tracy ; Zuo, Yunxia

Introduction:

Patients with limited-stage SCLC (LS-SCLC) have a substantial unmet clinical need for new treatments that delay disease progression and prolong survival.

Methods:

In this phase 2, multicenter, randomized, multiarm, open-label trial, patients with untreated LS-SCLC received ociperlimab and tislelizumab plus concurrent chemoradiotherapy (cCRT) (arm A), tislelizumab plus cCRT (arm B), or cCRT (arm C). The primary objective was to compare progression-free survival (PFS) per investigator for arms A and B versus C (NCT04952597). The contribution of ociperlimab was explored by comparison of arms A versus B. Statistical analyses were descriptive, with no formal hypothesis testing.

Results:

A total of 126 patients were randomized to arms A (N = 41), B (N = 42), and C (N = 43). The median PFS [95% confidence interval] exhibited a trend for improvement in arms A (12.6 [8.7-not estimable] months) and B (13.2 [8.5-not estimable]) compared with C (9.5 [8.3-14.4]); the PFS benefit was comparable between Arms A and B.The objective response rate, complete response rate, and median duration of response were numerically higher in arms A and B than in C. The median overall survival was not reached in all three arms, and the median distant metastasis-free survival revealed no trend for improvement for arms A and B compared with C. All patients experienced at least one treatment-related treatment-emergent adverse event.

Conclusions:

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.

01 Jul 2025·GYNECOLOGIC ONCOLOGY

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

Article

Author: Wang, Li ; Kim, Hee Seung ; Sinielnikov, Ivan Volodymyrovych ; Wang, Tao ; Mu, Xiyan ; Wang, Kai ; Lee, Jung-Yun ; Andabekov, Timur Turdeevich ; Boonyapipat, Sathana ; Wang, Wei ; Zhang, Xiang ; Yao, Desheng ; Kim, Yong Man ; Yuan, Guangwen ; Wu, Lingying ; Liu, Hu ; Lee, Jeong-Won ; Gao, Yujuan ; Chang, Chih-Long ; Wang, Danbo

OBJECTIVE:

Investigate the efficacy/safety of ociperlimab (anti-TIGIT monoclonal antibody [mAb]) + tislelizumab (anti-PD-1 mAb) in recurrent/metastatic (R/M) cervical cancer (CC).

METHODS:

Patients had R/M CC, received ≥1 prior chemotherapy, and were not amenable to curative treatment. In stage 1, 80 patients were randomized 1:1 to ociperlimab 900 mg + tislelizumab 200 mg every 3 weeks (cohort 1) or tislelizumab monotherapy (cohort 2). In stage 2, 98 additional patients were enrolled in cohort 1. Primary endpoint was blinded independent review committee-assessed objective response rate (ORR) by RECIST v1.1 for PD-L1+ subgroup and all-comers in cohort 1.

RESULTS:

Between March 2 and December 15, 2021, 178 patients were enrolled, and all were treated (cohort 1: 138; cohort 2: 40). ORR of cohort 1 PD-L1+ subgroup and all-comers were 27.4% (95% CI 18.2%-38.2%) and 23.2% (16.4%-31.1%), respectively. In cohort 1, median progression-free survival (PFS) was 3.0 months (95% CI 2.6-4.9) (all-comers) and 4.1 months (95% CI 2.7-6.9) (PD-L1+); median overall survival was 12.2 months (95% CI 9.9-16.6) (all-comers) and 16.4 months (95% CI, 10.4 months-not estimable) (PD-L1+). 70.3% of cohort 1 had ≥1 treatment-related adverse event (TRAE); 18.1% experienced ≥1 grade ≥3 TRAE. Immune-mediated AEs occurred in 35.5% of cohort 1.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04693234; https://clinicaltrials.gov/study/NCT04693234?term=NCT04693234&rank=1; EudraCT: https://eudract.ema.europa.eu/2020-004657-77.

News (Medical) associated with Ociperlimab

21 May 2026

·www.businesswire.com

BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that more than 60 abstracts across hematologic malignancies and solid tumors have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29–June 2, Chicago) and the 2026 European Hematology Association (EHA) Congress (June 11–14, Stockholm). Continuing to raise the bar in CLL At ASCO and EHA 2026, BeOne will showcase its hematology leadership with data spanning foundational therapies and next-generation innovation across CLL, mantle cell lymphoma and other B-cell malignancies. The data emphasize impressive long-term outcomes, durability across patient populations, and a disciplined approach to advancing future regimens. Collectively, these data underscore BeOne’s strategy to lead in hematology science and patient impact by setting the standard today – while helping to shape the future of CLL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “Seventy-eight-month follow-up data from SEQUOIA underscore what it truly takes to lead in CLL over the long term: long-term efficacy, ability for sequencing treatments, and confidence in first-line treatment decisions. Building on that leadership, we’re excited to be rapidly advancing the next generation of medicines, including sonrotoclax-based combinations and our BTK degrader BGB-16673, which are designed to extend what is possible for patients across lines of therapy.” Key data presentations in CLL include: New results from the SEQUOIA trial with 78 months follow-up reinforce BRUKINSA ® (zanubrutinib) as the foundational BTK inhibitor in CLL, with durable disease control that continues to raise expectations for what patients and physicians should expect from first-line therapy over the long term. Data will be presented at both ASCO and EHA. A subgroup analysis of SEQUOIA, which includes one of the largest and longest-followed cohorts of patients aged ≥80 years ever reported in a Phase 3 CLL study , showing that age did not limit benefit. Data will be presented at EHA 2026. Oral presentation at EHA 2026 of updated data of BeOne’s foundational BTK degrader – BGB-16673 – in patients with R/R CLL , demonstrating promising and durable activity and a manageable safety profile. An additional poster will be shared featuring never-before-presented data of BGB-16673 in BTK-naïve patients. BGB-16673 is the most advanced BTK degrader in the clinic, with more than 1,100 patients dosed. Data from the all-oral combination of BeOne’s foundational BCL2 inhibitor sonrotoclax plus zanubrutinib (ZS) in CLL , which demonstrated deep responses, unprecedented speed to undetectable MRD, and durable remissions and a generally well-tolerated safety profile. These data reinforce the potential for a next-generation, time-limited approach designed to deliver long-term outcomes without compromising durability or safety. Data will be presented as a poster at ASCO 2026 and an oral presentation at EHA 2026. Accelerating a high-potential solid tumor portfolio BeOne is highlighting strong momentum across its deep and diverse solid tumor portfolio at ASCO, with seven unique assets featured in three oral presentations and eight posters. These data span both in-line and pipeline therapies, including results demonstrating the differentiated profile of PD-1 inhibitor TEVIMBRA® (tislelizumab) across lung and gastrointestinal cancers, as well as in combination with the novel HER2-targeting agent ZIIHERA® (zanidatamab). The Company’s development superhighway is accelerating progress across all stages of development, generating compelling clinical data that support the potential of these therapies to reshape treatment in areas of high unmet need. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: “At ASCO 2026, we are demonstrating the strength of BeOne’s science, the scale of our pipeline, and the speed at which we are delivering innovation for patients. With multiple programs moving simultaneously toward pivotal trials, we are building durable disease leadership across breast, gynecologic, lung and gastrointestinal cancers – areas where substantial unmet patient need remains.” Key data presentations across our solid tumor programs include: First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer. Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data. Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody , with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients. Rapid oral presentation with a PD-L1 subgroup analysis of the HERIZON-GEA-01 trial in which TEVIMBRA in combination with ZIIHERA and chemotherapy demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with HER2+ gastroesophageal adenocarcinoma, irrespective of PD-L1 expression (in partnership with Jazz Pharmaceuticals). Investor webcast to highlight pipeline data at ASCO BeOne will host an investor webcast on June 1, 2026, at 7:00 PM CDT/8:00 PM EDT, led by John V. Oyler, Co-Founder, Chairman, and CEO, alongside the Company’s leadership team and invited key opinion leaders. The webcast will review clinical and corporate highlights from ASCO, provide updates on BeOne’s global R&D pipeline and platforms, and discuss the strategic priorities and execution capabilities driving the Company’s long-term growth. Webcast access details are available in the Investors section of BeOne’s website at http://ir.beonemedicines.com, https://hkexir.beonemedicines.com, and https://sseir.beonemedicines.com. An archived webcast will be available on the Company’s website. Full list of BeOne’s presentations at ASCO: Hematology BRUKINSA® (Zanubrutinib) Abstract Title Presentation Details Lead Author Subsequent therapies and time to second progression-free survival events in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab in SEQUOIA Poster Presentation: 544 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Constantine S. Tam Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization Poster Presentation: 556 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Alvaro Alencar Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia Poster Presentation: 545 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Daniel A. Ermann Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia Poster Presentation: 540 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Michael Fradley Real-world treatment survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States Poster Presentation: 543 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Ryan Jacobs A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States Poster Presentation: 560 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Yucai Wang Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib Abstract Number: e19020 Ryan Jacobs Risk factors for second primary malignancies in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: A real-world study Abstract Number: e19022 Lili Zhou Characterizing patient self-reported adherence to BTKis and symptoms in CLL/SLL using an electronic patient-reported outcomes platform Abstract Number: e19030 Mustafa Ascha Real-world treatment utilization, sequencing patterns, and healthcare resource utilization in Waldenström macroglobulinemia Abstract Number: e19056 Jorge Castillo Sonrotoclax Abstract Title Presentation Details Lead Author First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53 Poster Presentation: 541 Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Constantine S. Tam Sonrotoclax + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2) Poster Presentation: 596a Session Title: Poster Session - Hematologic Malignancies - Lymphoma and Chronic Lymphocytic Leukemia Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Mazyar Shadman Efficacy of sonrotoclax vs pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison Abstract Number: e19050 Alvaro Alencar Solid Tumors BGB-43395 (CDK4i) Abstract Title Presentation Details Lead Author First disclosure of frontline treatment with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer: A phase 1 safety expansion Poster Session: 180 Session Title: Poster Session - Breast Cancer - Metastatic Session Date/Time: June 1, 2026, 1:30-4:30 PM CDT Shom Goel BG-C9074 (B7-H4-targeting ADC) Abstract Title Presentation Details Lead Author First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion Rapid Oral Abstract: 3013 Session Title: Rapid Oral Abstract Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT Binghe Xu Consideration of adjusted ideal body weight dosing in BG-C9074 (B7-H4-targeting ADC) from pharmacokinetics, efficacy and safety perspectives Poster Session: 166 Session Title: Poster Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT Hugh Giovinazzo BGB-B2033 (GPC3x4-1BB bispecific antibody) Abstract Title Presentation Details Lead Author A phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy in patients with selected advanced or metastatic solid tumors: First disclosure of clinical data Rapid Oral Abstract: 3016 Session Title: Rapid Oral Abstract Session - Developmental Therapeutics - Molecularly Targeted Agents and Tumor Biology Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT Hong Jae Chon TEVIMBRA® (tislelizumab) and ZIIHERA® (zanidatamab) Abstract Title Presentation Details Lead Author Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: PD-L1 subgroup analysis from HERIZON-GEA-01 Rapid Oral Abstract: 4010 Session Title: Rapid Oral Abstract Session – Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: June 1, 2026, 1:15-2:45 PM CDT SunYoung Rha Characterization and management of gastrointestinal adverse events with zanidatamab + chemotherapy ± tislelizumab in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: Analysis from HERIZON-GEA-01 Poster Presentation: 25 Session Title: Poster Session – Gastrointestinal Cancer- Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: May 30, 2026, 9 AM-12:00 PM CDT Elena Elimova TEVIMBRA® (tislelizumab) Abstract Title Presentation Details Lead Author RATIONALE-315: Post hoc analysis of event-free survival by surgically relevant subgroups treated with perioperative tislelizumab and neoadjuvant chemotherapy vs neoadjuvant chemotherapy Poster Presentation: 533 Session Title: Poster Session - Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Session Date/Time: May 31, 2026, 9:00 AM-12:00 PM CDT Gustavo Schvartsman Quality-adjusted survival comparison for tislelizumab + chemotherapy (CT) versus placebo + CT as first-line treatment in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis: Long-term follow-up from RATIONALE-305 Poster Presentation: 17 Session Title: Poster Session - Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Session Date/Time: May 30, 2026, 9:00 AM-12:00 PM CDT Rutika Mehta A novel Bayesian approach for assessing associations between ECOG performance status and patient-reported outcomes in patients with gastric or gastroesophageal junction adenocarcinoma: Post hoc analysis from the RATIONALE-305 trial Abstract Number: e16044 Marcia Cruz-Correa Ociperlimab Abstract Title Presentation Details Lead Author Exploratory biomarker analysis of ociperlimab plus tislelizumab in patients with PD-L1-positive non-small cell lung cancer in AdvanTIG-105 Poster Session: 361 Session Title: Poster Session - Developmental Therapeutics - Immunotherapy Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT Jun Zhang BGB-A3055 (anti-CCR8) Abstract Title Presentation Details Lead Author A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti-PD-1) in patients with solid tumors Poster Session: 313 Session Title: Poster Session - Developmental Therapeutics - Immunotherapy Session Date/Time: May 30, 2026, 1:30 PM-4:30 PM CDT Judith Raimbourg Full list of BeOne’s presentations at EHA: Zanubrutinib Abstract Title Presentation Details Lead Author Long-term follow-up for safety and efficacy of zanubrutinib in elderly (≥80 years) treatment naïve CLL/SLL patients, including those with del(17p): Subgroup analysis from the SEQUOIA trial Publication Number: PS1703 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Alessandra Tedeschi Subsequent therapies and time to second progression-free survival events in chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab Publication Number: PF601 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Mazyar Shadman Zanubrutinib vs ibrutinib in treatment-naive chronic lymphocytic leukemia (CLL): Implications for interpreting fixed-duration treatment outcomes from CLL17 Publication Number: PS1718 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Talha Munir Associations between ECOG performance status and patient-reported outcomes in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: Post hoc analysis from the ALPINE trial Publication Number: PS2492 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Nicole Lamanna A longitudinal analysis of patients with CLL/SLL with impaired health-related quality of life scores at baseline who were treated with zanubrutinib versus ibrutinib: A post hoc analysis of ALPINE Publication Number: PF1398 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Loic Ysebaert Real-world zanubrutinib treatment patterns in CLL/SLL among US community oncology patients with prior acalabrutinib therapy Publication Number: PF618 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Jing-Zhou Hou Patterns of treatment utilization and sequencing across lines of therapy in Waldenström macroglobulinemia: Real-world evidence from the United States Publication Number: PS2516 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Prashant Kapoor Real-world comparative analysis of treatment discontinuation with covalent Bruton tyrosine kinase inhibitors in first-line chronic lymphocytic leukemia Publication Number: PS1710 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Nakhle Saba Real-world treatment and survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States Publication Number: PF608 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Ryan Jacobs A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States Publication Number: PS2040 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Yucai Wang Clinical outcomes among patients with relapsed/refractory mantle cell lymphoma receiving zanubrutinib or acalabrutinib in real-world practice in the United States Publication Number: PF958 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Javier Munoz Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia Publication Number: PS2515 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Rhys Williams Treatment burden among patients aged 75 or older with chronic lymphocytic leukemia and small lymphocytic lymphoma Publication Number: PF605 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Daniel Ermann Real-world effectiveness and safety of zanubrutinib in Waldenström macroglobulinemia: Results from the Belgian WIZARD study Abstract Number: PB3600 Willem Daneels Real-world experience with zanubrutinib in chronic lymphocytic leukaemia - patient profile, treatment patterns, and safety: Preliminary analysis of French ROZALY study Abstract Number: PB2898 Florian Bouclet BRUMIZE: Real-world zanubrutinib use and preliminary safety in R/R marginal zone lymphoma in Europe Abstract Number: PB3632 Côme Bommier Indirect comparison of zanubrutinib vs acalabrutinib and ibrutinib efficacy in patients with treatment-naïve chronic lymphocytic leukemia Abstract Number: PB2895 Mazyar Shadman Patient-reported outcomes and disease progression in chronic lymphocytic leukemia and small lymphocytic lymphoma: A systematic literature review and gap analysis Abstract Number: PB2909 Loic Ysebaert Understanding patients' perspectives and preferences regarding first-line chronic lymphocytic leukemia treatment across Europe Abstract Number: PB2934 Lydia Scarfò Number of deaths avoided with use of zanubrutinib versus ibrutinib for the treatment of chronic lymphocytic leukemia in Europe Abstract Number: PB2944 Talha Munir Real-world intravenous immunoglobulin utilization in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma treated with venetoclax plus obinutuzumab vs zanubrutinib Abstract Number: PB2915 Nicole Lamanna Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia Abstract Number: PB2901 Daniel A. Ermann Exploring the patient and hematologist preference of treatment characteristics for chronic lymphocytic leukemia: A qualitative study in Europe Abstract Number: PB4474 Lydia Scarfò Sonrotoclax Abstract Title Presentation Details Lead Author First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53 Publication Number: S145 Session: s424 Prognostication and first line therapy in CLL Session Date/Time: June 12, 2026 17:15 - 18:30 CEST Chan Y. Cheah Updated safety and efficacy of all-oral sonrotoclax + zanubrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with del(17p)/TP53 Publication Number: PS1697 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Stephen S. Opat Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib in patients with relapsed/refractory mantle cell lymphoma: Results from a phase 1/1b study Publication Number: PF933 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Jacob D. Soumerai Phase 1/2 study of sonrotoclax (BGB-11417) monotherapy in Bruton tyrosine kinase inhibitor–pretreated relapsed/refractory mantle cell lymphoma: A Chinese subpopulation analysis Publication Number: PF961 Session: Poster Session 1 Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST Yuqin Song Sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2) Abstract Number: PB2966 Mazyar Shadman Efficacy of sonrotoclax versus pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison Abstract Number: PB3626 Toby A. Eyre Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization Abstract Number: PB3617 Toby A. Eyre Risk of tumor lysis syndrome among venetoclax-treated patients with chronic lymphocytic leukemia or mantle cell lymphoma: A real-world study Abstract Number: PB2896 Alessandra Ferrajoli BGB-16673 Abstract Title Presentation Details Lead Author BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: A phase 1 CaDAnCe-101 study update Publication Number: S152 Session: s449 Novel therapies in relapsed/refractory CLL Session Date/Time: June 14, 2026 11:00 - 12:15 CEST Stephan Stilgenbauer Bruton tyrosine kinase (BTK) degrader BGB-16673 in BTK inhibitor–naive patients with CLL/SLL and other B-cell malignancies: Results from the phase 1 CaDAnCe-101 study Publication Number: PS1693 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Irina Mocanu BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory Waldenström macroglobulinemia: A phase 1 CaDAnCe-101 study update Publication Number: PS2033 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Judith Trotman BGB-16673, a Bruton tyrosine kinase degrader, has low risk of CYP3A-mediated drug-drug interaction (DDI): Phase 1 absorption, distribution, metabolism, and excretion and DDI study results Publication Number: PS1711 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Judith Trotman BGB-16673 versus idelalisib + rituximab (R), bendamustine + R, or venetoclax + R re-treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: The phase 3 CaDAnCe-302 trial Abstract Number: PB2925 Paolo Ghia Tislelizumab Abstract Title Presentation Details Lead Author Evaluation of PET-CT metrics and pharmacokinetics in adults receiving tislelizumab for relapsed/refractory classical Hodgkin lymphoma: Ancillary analyses of LYSA phase 2 TIRHOL study BGB-A317-210 Publication Number: PS2028 Session: Poster Session 2 Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST Hervé Ghesquières About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. With the broadest label globally, BRUKINSA is the foundational BTK inhibitor. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing and the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally. About BEQALZI™ (sonrotoclax) BEQALZI™ (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. BEQALZI has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program. About BGB-16673 BGB-16673 is a foundational and potential first-in-class and best-in-class Bruton’s tyrosine kinase (BTK) degrader for the treatment of B-cell malignancies. With 1,100+ patients dosed to date in an extensive global clinical development program, BGB-16673 is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted BGB-16673 PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor. About ZIIHERA (zanidatamab) ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions. ZIIHERA is a registered trademark of Zymeworks BC Inc. About TEVIMBRA (tislelizumab) TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved in over 50 countries, and more than 2 million patients have been treated globally. Select Important Safety Information for BRUKINSA® (zanubrutinib) Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Please see full U.S. Prescribing Information including U.S. Patient Information. Select Important Safety Information for BEQALZITM (sonrotoclax) Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome. In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%). Please see full Prescribing Information. Select Important Safety Information for TEVIMBRA Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity. Please see full U.S. Prescribing Information including the U.S. Medication Guide. The information provided in this press release is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s ability to advance future regiments and lead in hematology; BeOne’s ability to build durable disease area leadership in solid tumors; BeOne’s clinical development plans for various programs; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom site. ____________________ 1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.).

Phase 1ASCOPhase 3Clinical ResultImmunotherapy

13 Jun 2025

·www.fiercebiotech.com

The trouble with TIGITs: How \'overenthusiasm\' led to Big Pharma\'s risky $6B gamble

“People went for Fc-competent [TIGITs] because it worked best in mice,” said Leerink Partners analyst Daina Graybosch, Ph.D. “They couldn\'t help themselves.\"\n Once hailed as the future of immuno-oncology, it’s been a tough few months for any remaining fans of anti-TIGIT antibodies.In April, BeOne Medicines, formerly known as BeiGene, announced it was scrapping ociperlimab over a disappointing phase 3 outlook two years after Novartis handed back the asset. Specifically, the study’s independent data monitoring committee deemed the trial unlikely to show that a combination of ociperlimab and BeOne’s own PD-1 inhibitor Tevimbra would beat Keytruda in patients with PD-L1-high non-small cell lung cancer (NSCLC).The following month brought more tough times for TIGITs, as GSK halted development of its own candidate belrestotug after deciding the iTeos Therapeutics-partnered drug in combination with anti-PD-1 inhibitor Jemperli wouldn’t score a phase 2 win in a similar NSCLC population.Even executives at Roche, whose tiragolumab appeared to buck the trend with a caveated phase 3 win in esophageal cancer in 2024, reaffirmed to Fierce Biotech earlier this year that “we stopped all of the tiragolumab trials that we could stop, and those that couldn\'t be stopped are just running out.”With Big Pharma having pumped $6 billion into this modality, what went so wrong for TIGITs?Daina Graybosch, Ph.D., a senior research analyst at Leerink Partners who covers immuno-oncology, traces the problems back to the exuberant reaction to Roche’s impressive phase 2 tiragolumab data that read out across 2020 and 2021. The Cityscape trial demonstrated that the TIGIT drug in combination with Roche’s own PD-L1 blocker Tecentriq shrank tumors in 31% of patients with metastatic lung cancer—twice as many patients as Tecentriq alone.“That\'s probably the biggest point where the field went wrong, in that they looked at this massive benefit in the small phase 2, and everybody ran after it in a parallel and broad way,” Graybosch told Fierce in an interview.“We had randomized phase 2 data from Roche, from Arcus-Gilead, from iTeos-GSK, and they all consistently showed benefit in response rate and in [progression-free survival],” she added.“I think the challenge ultimately was: How much benefit is there really? Is it enough benefit to be clinically meaningful? And are we developing the drugs in the right way, in the right format, to optimize and bring that benefit to patients?”The industry’s “overenthusiasm” for the potential of TIGITs led to a “simplistic approach” to how other companies planned to develop their own candidates, according to Graybosch.If pharmas had anticipated a “more realistic demonstration of benefit,” as seen in the failed Skyscraper-01 phase 3 study in NSCLC, “I think everybody would have developed [TIGITs] differently,” she suggested.Companies swimming in the TIGIT space have broadly fallen into two camps. Roche’s tiragolumab, along with Merck & Co.’s vibostolimab, GSK and iTeos’ EOS-448, and BeOne’s ociperlimab, are all Fc-enabled. These antibodies retain a fully functional Fc region, meaning they can bind to Fc receptors found on the cell surface and contribute to the protective antitumor functions of the immune system.The theory behind Fc-enabled anti-TIGIT antibodies is that they have enhanced tumor-killing effects. However, the risk is that they could possibly also eliminate certain regulatory T cells and therefore lead to unwanted immune responses.In fact, side effects did cast a shadow over some of the Fc-enabled TIGIT trials, with Merck halting a phase 3 trial of vibostolimab due to a higher than expected rate of discontinuations blamed on “immune-mediated adverse experiences.”“Toxicity that may lead patients to discontinue I think ended up being a contributing factor across the Fc-enabled TIGITs that are all now dead,” Graybosch said.The last TIGITs still standing—Arcus Biosciences and Gilead’s domvanalimab, as well as AstraZeneca’s TIGIT/PD-1 bispecific antibody rilvegostomig—have mutated out the Fc function. This should mean they are less toxic for patients.“People went for Fc-competent because it worked best in mice,” Graybosch explained. “They couldn\'t help themselves, even though they knew there was some risk of depleting T effector cells that are actually what you need to fight your tumor.” Focusing on \'modest benefit\'So, what would a more measured approach to the TIGIT gold rush have meant in practice?“I think you ultimately do what Astra is doing,” said Graybosch, referring to AstraZeneca’s ongoing phase 3 trials of its bispecific rilvegostomig in a range of phase 3 studies for NSCLC or stomach cancer, including in combination with its Daiichi Sankyo-partnered antibody-drug conjugates Enhertu or Datroway.“Astra is recognizing the modest benefit,” she explained. “Their bispecific is very safe because it\'s Fc silent. And in some ways, Astra can\'t lose because [rilvegostomig] doesn\'t need to work that much for a lot of their trials to be successful.”AstraZeneca’s Puja Sapra, Ph.D., senior vice president for biologics engineering and oncology target discovery, was also upbeat about rilvegostomig’s prospects when she spoke to Fierce back in April. She pointed to the fact that engineering the bispecific to reduce Fc effector functionality should reduce unwanted side effects, while blocking both PD-1 and TIGIT at the same time “should hopefully help us increase the response rate and durability.”“At least in preclinical studies, we see that a bispecific molecule has better responses than a combination of both agents alone,” Sapra said at the time. “The molecule is doing very well in the clinic so far, so we continue to believe in this molecule.”Gilead is also staying loyal to its TIGIT candidate, which is being evaluated in phase 3 trials for first-line NSCLC as well as for locally advanced unresectable or metastatic gastric, gastroesophageal junction and esophageal adenocarcinoma.The pharma’s chief medical officer Dietmar Berger, M.D., Ph.D., told Fierce earlier this month that the Arcus-partnered domvanalimab still has a chance, pointing to its Fc-silent character.“We believe there is differentiation but, of course, we need to see how those studies read out,” Berger said. “Any additional activities around that will be based on what we see in those studies.”With AstraZeneca and Gilead still holding a candle for their Fc-silent candidates, Leerink’s Graybosch doesn’t think “it\'s fair to completely write off TIGIT.”“But if you ask 99% of average investors, generalists or specialists and [key opinion leaders], I think they’ll tell you it\'s dead,” she added.Angus Liu contributed to this reporting.

$The trouble with TIGITs: How \'overenthusiasm\' led to Big Pharma\'s risky $6B gamble$

Phase 3Clinical ResultPhase 2

14 May 2025

·www.businesswire.com

BeiGene Showcases Strength of Hematology Portfolio at EHA 2025 with New Data Highlighting BRUKINSA’s Leadership and Next-Generation Innovation

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines Ltd., today announced it will share data across a range of hematologic malignancies at the European Hematology Association (EHA) Congress in Milan, Italy, June 12–15. BeiGene has 31 abstracts accepted at EHA 2025, with four selected for oral presentations, featuring data from its best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib) and its investigational pipeline assets – a next-generation BCL2 inhibitor, sonrotoclax, and BTK protein degrader, BGB-16673. These data reflect BeiGene’s vision to redefine standards of care in hematology through next-generation science and patient-focused innovation. “With three cornerstone hematology assets – BRUKINSA, sonrotoclax and BGB-16673 – we are advancing a potentially best-in-class portfolio in B-cell malignancies,” said Lai Wang, Ph.D. Global Head of R&D. “At EHA 2025, we’ll share 31 accepted abstracts that highlight the progress of our hematology clinical development program and our commitment to targeted therapies that raise the standard of care. As BRUKINSA continues to expand its impact and our next-generation assets advance, we hope to transform the future of treatment for patients facing B-cell malignancies.” BeiGene’s next-generation pipeline assets, including BGB-16673 and sonrotoclax, continue to demonstrate promising clinical activity and generally well-tolerated safety profiles across multiple B-cell malignancies. Together, these programs have enrolled more than 2,500 patients globally (1,900+ patients for sonrotoclax and 600+ patients for BGB-16673) and are positioned to potentially play a significant role in treatment strategies for chronic lymphocytic leukemia (CLL), Waldenström’s macroglobulinemia (WM) and mantle cell lymphoma (MCL). Additionally, presentations further reinforce BRUKINSA’s durable efficacy and consistent safety profile, as well as its position as a foundational therapeutic option in frontline CLL. Key highlights include: Two oral presentations featuring updated results from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in patients with relapsed or refractory (R/R) CLL/SLL and patients with R/R WM, showing continued and promising early efficacy and a tolerable safety profile. Two oral presentations showcasing updated Phase 1 results of sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL, which demonstrate deep and durable responses. This combination is now under evaluation in the ongoing registrational Phase 3 fixed-duration CELESTIAL-TNCLL study ( NCT06073821 ) in patients with treatment-naïve CLL/SLL, which completed enrollment earlier this year, and CELESTIAL-RRMCL study ( NCT06742996 ) in patients with relapsed / refractory MCL, which is currently enrolling. Results from Arm C and D of the SEQUOIA study, which evaluated BRUKINSA in patients with TN CLL/SLL and del(17p) (Arm C) and BRUKINSA plus venetoclax in patients with TN CLL/SLL with del(17p) and/or TP53 mutation or without either mutation (Arm D). Robust analyses across clinical trials and real-world evidence that deepen understanding of treatment patterns, safety, and outcomes in CLL/SLL, MCL and diffuse large B-cell lymphoma (DLBCL). BeiGene Presentations and Publications at EHA2025 Abstract Title Presentation Details (CEST) Lead Author BGB-16673 (BTK CDAC) Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory CLL/SLL: results from the ongoing phase 1 CaDAnCe-101 study Oral Presentation: S158 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 L. Scarfò Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory Waldenström macroglobulinemia: ongoing phase 1 CaDAnCe-101 study results Oral Presentation: S231 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 A.M. Frustaci Sonrotoclax (BCL2 Inhibitor) Updated results from the phase 1 study of sonrotoclax (BGB-11417), a novel BCL2 inhibitor, in combination with zanubrutinib for relapsed/refractory CLL/SLL show deep and durable responses Oral Presentation: S159 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 C.Y. Cheah Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib induces high rate of complete remission for patients with relapsed/refractory mantle cell lymphoma Oral Presentation: S234 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 C.S. Tam Sonrotoclax monotherapy for treatment of patients with relapsed/refractory CLL: data from an ongoing phase 1/1b study (BGB-11417-101) Poster #: PF580 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 S.S. Opat Updated safety and efficacy results of a phase 1 study of the novel BCL2 inhibitor sonrotoclax (BGB-11417) for relapsed/refractory Waldenström's macroglobulinemia Poster #: PF887 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C.Y. Cheah Primary analysis results of novel BCL2 inhibitor sonrotoclax (BGB-11417) monotherapy in patients with relapsed/refractory b-cell malignancies Poster #: PF574 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C. Li Updated safety and antileukemic activity data for sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in patients with relapsed/refractory acute myeloid leukemia Poster #: PF491 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 P. Montesinos Updated safety and antileukemic activity data of sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in treatment-naive patients with acute myeloid leukemia unfit for intensive chemotherapy Poster #: PF477 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 J. Shortt Updated interim results of sonrotoclax plus dexamethasone in patients with t(11;14)-positive relapsed/refractory multiple myeloma: an all-oral treatment Poster #: PF721 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 B. Dhakal BGB-11417-302, a phase 3, randomized, double-blind study of sonrotoclax (BGB-11417) plus zanubrutinib versus placebo plus zanubrutinib in patients with relapsed or refractory mantle cell lymphoma Publication Only M. Hughes BRUKINSA SEQUOIA 5-year follow-up in arm C: frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma Poster #: PS1565 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 C.S. Tam Combination of zanubrutinib plus venetoclax for treatment-naive CLL/SLL: results in SEQUOIA arm D Poster #: PS1566 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 M. Shadman Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1918 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Z. Song Additional Abstracts Integrative Evidence Generation and Health Economics Related to Zanubrutinib Final independent review data supports sustained benefit of zanubrutinib over ibrutinib in patients with R/R CLL/SLL in ALPINE Publication Only J. Brown Preference Survey and Patient Experience Study Preferences for treatment in first-line chronic lymphocytic leukemia: A multi-criteria decision analysis in Italy Publication Only P. Sportoletti A qualitative study to explore the patient experience of continuous covalent Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: study methodology Publication Only L. Scarfò Real-World Evidence Real-world burden of disease, treatment patterns and outcomes in patients with mantle cell lymphoma Poster #: PF899 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Alencar Real-world comparative effectiveness of first-line Bruton tyrosine kinase inhibitors in patients with chronic lymphocytic leukemia Poster #: PS1578 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 R. Jacobs Real-world treatment utilization patterns, discontinuation and healthcare resource utilization of first-line Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: age-related disparity Poster #: PF585 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 K. Yang Risk of hypertension in patients newly diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and treated with covalent Bruton tyrosine kinase inhibitors: a real-world study Poster #: PF588 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Ali Real-world Bruton tyrosine kinase inhibitor use and clinical outcomes among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma Publication Only J. Hou Real-world zanubrutinib treatment patterns in chronic lymphocytic leukemia/small lymphocytic lymphoma among US community oncology patients with prior acalabrutinib therapy Publication Only J. Hou Real-world zanubrutinib treatment patterns in mantle cell lymphoma among US community oncology patients with prior Bruton tyrosine kinase inhibitor therapy Poster #: PF914 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 R. Choksi Evaluating uptake of targeted agents by race/ethnicity in patients receiving first-line treatment for chronic lymphocytic leukemia Publication Only A.S. Kittai Serious infections in patients with CLL/SLL treated with combination venetoclax and obinutuzumab compared with those treated with zanubrutinib: a real-world study Poster #: PS1571 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 N. Lamanna Matching-Adjusted Indirect Comparison Comparative efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax for first-line treatment of chronic lymphocytic leukemia: a matching-adjusted indirect comparison Poster #: PS1581 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 T. Munir Efficacy of continuous zanubrutinib vs fixed-duration venetoclax in combination with obinutuzumab in treatment-naive chronic lymphocytic leukemia: a matching-adjusted indirect comparison Publication only T. Munir Adverse events of interest with zanubrutinib vs fixed-duration combination of venetoclax plus obinutuzumab in treatment-naive chronic lymphocytic leukemia Publication only N. Lamanna Network Meta-Analysis A network meta-analysis of efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax in treatment-naïve chronic lymphocytic leukemia Publication Only M. Shadman Ociperlimab (BGB-A1217) Advantig-101: a phase 1b/2 study of ociperlimab plus tislelizumab or rituximab in relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1995 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Q. Cai About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB‑16673 BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeiGene’s chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström’s macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. This information is intended for a global audience. Product indications vary by region. About BeiGene BeiGene, which will change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength of BeiGene’s hematology portfolio; BeiGene’s commitment to transform treatment for B-cell malignancies; BeiGene’s commitment to targeted therapies that raise the standard of care; the future impact of BRUKINSA; the advancement of BeiGene’s next-generation assets including clinical activities and safety profiles; the role BGB-16673 and sonrotoclax will play in treatment strategies for CLL, WM and MCL; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. To access BeiGene media resources, please visit our News & Media site.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	BeOne Medicines Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	BeOne Medicines Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	BeOne Medicines Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Spain	BeOne Medicines Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	BeOne Medicines Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	United States	BeOne Medicines Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	China	BeOne Medicines Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Australia	BeOne Medicines Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Spain	BeOne Medicines Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	BeOne Medicines Ltd.	17 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04746924 (AdvanTIG-302, Pubmed \| J Thorac Oncol)	Phase 3	Non-Small Cell Lung Cancer First line	662	Ociperlimab + Tislelizumab	qlhghidtxz(wicmpbucqs) = qmgyfthyyy yrzlnvtnle (lnqyzkcpgm, 25.7 - NE) View more	Negative	01 Jul 2026
				Pembrolizumab	qlhghidtxz(wicmpbucqs) = zdtcnjdoof yrzlnvtnle (lnqyzkcpgm, 25.8 - 35.0) View more
NCT04746924 (AdvanTIG-302, CTgov)	Phase 3	Non-Small Cell Lung Cancer \| metastatic non-small cell lung cancer	669	Tislelizumab+Ociperlimab (Arm A: Ociperlimab Plus Tislelizumab)	rjeijaeted(yriolwpzak) = ghojwtvnqu zpxnrefvtx (olbtxrlvtf, nrfvyjolal - rsgbdydave) View more	-	12 May 2026
				Placebo+Pembrolizumab (Arm B: Pembrolizumab Plus Placebo)	rjeijaeted(yriolwpzak) = tkyfieiycg zpxnrefvtx (olbtxrlvtf, poosigeiue - wpizcisacu) View more
NCT04746924 (AdvanTIG-302, ESMO_IO2025)	Phase 3	Non-Small Cell Lung Cancer First line PD-L1 High	662	OCI + TIS	ojnfozdvao(kattpbgrnq) = sphcxgvijw iayfnwhekw (kaxyqboczn, 25.7 - NE) View more	Negative	12 Oct 2025
				PEM	ojnfozdvao(kattpbgrnq) = dspsveolgw iayfnwhekw (kaxyqboczn, 25.8 - 35.0) View more
NCT05014815 (AdvanTIG-205, CTgov)	Phase 2	Non-small cell lung cancer stage IIIB \| metastatic non-small cell lung cancer \| Locally Advanced Lung Non-Small Cell Carcinoma	272	Tislelizumab+nab paclitaxel+Carboplatin+Pemetrexed+cisplatin+Ociperlimab (Arm A (O+T+C))	gempusuywp(bkxvgiwmww) = lgsgmcchey rhuschdhcg (utczuhwrsl, yyyvxxvsmh - liucggxubj) View more	-	16 Sep 2025
				Placebo+Tislelizumab+nab paclitaxel+Carboplatin+Pemetrexed+cisplatin (Arm B (P+T+C))	gempusuywp(bkxvgiwmww) = fgolngifrg rhuschdhcg (utczuhwrsl, kutnhdbvwf - bubkpzuavl) View more
NCT05267054 (ADVANTIG-101, CTgov)	Phase 1/2	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent	53	Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab)	vhptyteoxj = tgmwxnzoau jqodnwslop (cjtwcrysxo, pepzdjwnce - hrnhzwhpox) View more	-	15 Sep 2025
				Rituximab+Ociperlimab (Ociperlimab + Rituximab)	vhptyteoxj = pobelfrses jqodnwslop (cjtwcrysxo, tzshuizmsi - gjwdmtfkcj) View more
NCT05577702 (BGBLC202, WCLC2025)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	121	Tislelizumab (PD-L1 TC ≥50%, TIS (anti-PD-1))	oebhbdktha(pbdjcupmig) = wozfpqqnmf xlcmzseoiv (kiaqmvyzws ) View more	Positive	08 Sep 2025
				Tislelizumab+OciperlimabTislelizumab+Ociperlimabociperlimab (anti-TIGIT) (PD-L1 TC ≥50%, TIS plus ociperlimab (anti-TIGIT))	oebhbdktha(pbdjcupmig) = exorcbprlh xlcmzseoiv (kiaqmvyzws ) View more
NCT05023109 (ZSAB-TOP, Signal Transduct Target Ther) Manual	Phase 2	Advanced biliary tract cancer First line TIGIT	45	Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin	mxvstretii(buhyytdwmj) = vlmoztwobi rarpxnrthb (syyesisieg, 35.1 - 67.1) View more	Positive	21 Aug 2025
				Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin (TIGIT+/PD-L1+)	mxvstretii(buhyytdwmj) = simdhngsbn rarpxnrthb (syyesisieg, 47.6 - 92.7)
NCT04693234 (AdvanTIG-202, Pubmed \| Gynecol Oncol)	Phase 2	Metastatic Carcinoma to the Uterine Cervix PD-L1+	178	Ociperlimab 900 mg + Tislelizumab 200 mg	lgpiryveuk(toamtvneyd) = bezvixpipi zyycwpijlc (omujxvsiza, 16.4% - 31.1) View more	Positive	01 Jul 2025
NCT05267054 (ADVANTIG-101, EHA2025)	Phase 1/2	Diffuse Large B-Cell Lymphoma PD-L1 \| TIGIT positive	53	Ociperlimab + Tislelizumab	qpsazxdcok(dqujniixmf) = asewoquzdb opliloncxc (hzmkjyfuyx, 5.0–38.8)	Negative	14 May 2025
				Ociperlimab + Rituximab	qpsazxdcok(dqujniixmf) = ucxjpcjrel opliloncxc (hzmkjyfuyx, 6.6–38.1)
NCT04693234 (AdvanTIG-202, CTgov)	Phase 2	Metastatic Carcinoma to the Uterine Cervix	178	Tislelizumab+Ociperlimab (Cohort 1: Ociperlimab + Tislelizumab)	xhrjxykqdi = hghtrmhtzw quomsoonmd (oqbgzmckhi, uqgrijhjer - qvojqtnbrz) View more	-	27 Apr 2025
				Tislelizumab (Cohort 2: Tislelizumab)	zxmqjqgzif = gnfyqshcse cxaozbjlrz (zufavvkufe, kwxmxbicmb - dvdftizqet) View more

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