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.

ChiCTR2400092029

/ RecruitingPhase 2IIT

The efficacy and safety of Tislelizumab combined with Ociperlimab and chemotherapy in the perioperative treatment of resectable esophageal squamous cell carcinoma: a single arm phase II study

Start Date15 Mar 2023

Sponsor / Collaborator-

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 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 ; Yao, Desheng ; Zhang, Xiang ; 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.

01 May 2024·Structure (London, England : 1993)

Structural insights into the unique pH-responsive characteristics of the anti-TIGIT therapeutic antibody Ociperlimab

Article

Author: Li, Kang ; Chen, Xin ; Zhang, Xiangxiang ; Xue, Liu ; Huang, Chichi ; Song, Jing ; Shen, Zhirong ; Cheng, Liang ; Sun, Jian ; Wang, Lai ; Zhang, Jing

TIGIT is mainly expressed on T cells and is an inhibitory checkpoint receptor that binds to its ligand PVR in the tumor microenvironment. Anti-TIGIT monoclonal antibodies (mAbs) such as Ociperlimab and Tiragolumab block the TIGIT-PVR interaction and are in clinical development. However, the molecular blockade mechanism of these mAbs remains elusive. Here, we report the crystal structures of TIGIT in complex with Ociperlimab_Fab and Tiragolumab_Fab revealing that both mAbs bind TIGIT with a large steric clash with PVR. Furthermore, several critical epitopic residues are identified. Interestingly, the binding affinity of Ociperlimab toward TIGIT increases approximately 17-fold when lowering the pH from 7.4 to 6.0. Our structure shows a strong electrostatic interaction between ASP103_HCDR3 and HIS76_TIGIT explaining the pH-responsive mechanism of Ociperlimab. In contrast, Tiragolumab does not show an acidic pH-dependent binding enhancement. Our results provide valuable information that could help to improve the efficacy of therapeutic antibodies for cancer treatment.

01 Oct 2023·Journal for immunotherapy of cancer

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors

Article

Author: Rizwan, Ahsan ; Frentzas, Sophia ; Budha, Nageshwar ; Tan, Wei ; Zheng, Hao ; Meniawy, Tarek ; Kao, Steven ; de la Hoz Pedroza, Luz ; Gao, Rang

Background:

Ociperlimab, a novel, humanized monoclonal antibody (mAb), binds to T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) with high affinity and specificity. Tislelizumab is an anti-programmed cell death protein 1 mAb. We report results from a phase I, first-in-human, dose escalation study evaluating the safety, pharmacokinetics (PK), and preliminary antitumor activity of ociperlimab plus tislelizumab in patients with advanced solid tumors.

Methods:

Eligible patients previously treated with standard systemic therapy, or for whom treatment was not available or tolerated, received ociperlimab intravenously on Cycle (C) 1 Day (D) 1 and tislelizumab 200 mg intravenously on C1 D8. If tolerated, patients received ociperlimab plus tislelizumab 200 mg sequentially on D29 and every 3 weeks (Q3W) thereafter until discontinuation. Dose escalation for ociperlimab was planned with four dose levels (50 mg, 150 mg, 450 mg, and 900 mg) according to a 3+3 design. An additional dose level of ociperlimab 1800 mg was also assessed. Primary endpoints were safety, determination of the maximum tolerated (or administered) dose, and the recommended phase II dose (RP2D). Secondary endpoints included overall response rate (ORR), duration of response (DoR), disease control rate (DCR) (Response Evaluation Criteria in Solid Tumors version 1.1), PK, and biomarker analysis.

Results:

At data cut-off (September 29, 2022), 32 patients had received ≥1 dose of ociperlimab plus tislelizumab 200 mg Q3W. The maximum administered dose was ociperlimab 1800 mg plus tislelizumab 200 mg Q3W. The median age of enrolled patients was 59.5 years (range: 31–79). Most patients (96.9%) experienced ≥1 treatment-emergent adverse event (TEAE); 62.5% of patients experienced ≥grade 3 TEAEs and 50.0% of patients experienced serious TEAEs. No dose limiting toxicity events were reported. The maximum tolerated dose was not reached. The RP2D was ociperlimab 900 mg plus tislelizumab 200 mg Q3W. Overall, ORR was 10.0%, median DoR was 3.6 months, and DCR was 50.0%.

Conclusions:

Ociperlimab plus tislelizumab was well tolerated in patients with advanced solid tumors, and preliminary antitumor activity was observed with 450 mg, 900 mg, and 1800 mg ociperlimab. Phase II/III trials of ociperlimab 900 mg plus tislelizumab 200 mg Q3W are underway in a range of solid tumors.

Trial registration number:

NCT04047862.

News (Medical) associated with Ociperlimab

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.

Phase 1Phase 3Clinical ResultDrug ApprovalFast Track

14 May 2025

·www.pharmaceutical-technology.com

GSK and iTeos drop anti-TIGIT drug following trial failure

GSK and iTeos have said they are stopping all development programmes for their anti-TIGIT antibody belrestotug. Image credit: Shutterstock / FON’s Fasai. GSK and iTeos are the latest companies to scrap a jointly developed anti-TIGIT drug after it failed to demonstrate a meaningful benefit in two Phase II trials. Belrestotug, a human IgG1 antibody created to bind with high-affinity T cell immunoglobulin and ITIM domains (TIGIT), was being developed as part of a partnership harnessed between the companies in June 2021 . The companies announced on 13 May that they were slashing the programme after receiving new interim analyses from the Phase II GALAXIES Lung-201 (NCT05565378) and GALAXIES H&N-202 (NCT06062420) studies, which did not meet their efficacy endpoints. Both trials were investigating the drug in combination with the PD-1 monoclonal antibody Jemperli (dostarlimab). However, the GALAXIES Lung-201 study was in patients with previously untreated, advanced/metastatic non-small-cell lung cancer (NSCLC). Meanwhile, the GALAXIES H&N-202 trial was in patients with PD-L1 positive recurrent/metastatic squamous cell carcinoma of the head and neck. iTeos reported that while the GALAXIES Lung-201 trial demonstrated clinically meaningful improvements in the primary endpoint of objective response rate (ORR), however, the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression-free survival (PFS). Analysis from the GALAXIES H&N-202 trial showed a trend below the meaningful threshold for ORR in the combination cohort. In a company statement, GSK says that due to the failures, the collaboration and all belrestotug study cohorts are ending. iTeos clarified that this includes enrolment in the ongoing GALAXIES Lung-301 Phase III trial. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence iTeos’ president and chief executive officer Dr Michel Detheux said: “We are truly disappointed by the results from GALAXIES Lung-201. Following the analysis of the TIGIT data generated to date with GSK, we have made the mutual decision to discontinue the development of all ongoing TIGIT studies.” GSK joins pharma giants dropping anti-TIGIT drugs The news may come as a shock to the oncology field, as GSK and iTeos provided the first data for the GALAXIES Lung-201 study at the European Society for Medical Oncology (ESMO) Congress 2024 last September. The data seemed to show a positive trend with an ORR of between 63.3% and 76.7% versus 37.5% for Jemperli as a monotherapy. The mechanism has proven challenging, with GSK and iTeos becoming the latest companies to terminate an anti-TIGIT asset. Last month, BeiGene announced it was terminating development of ociperlimab , which it had been manufacturing as a treatment for lung cancer. In December 2024, MSD scrapped the development of its anti-TIGIT antibody vibostolimab after the Phase III KeyVibe-003 and KeyVibe-007 trials met the pre-specified futility criteria for the primary endpoint of overall survival (OS) in patients with NSCLC. The company stopped the KeyVibe-008 trial last year . In November 2024, Roche reported a failure with its candidate tiragolumab , which was being trialled in the Phase III Skyscraper-01 study. This came after earlier setbacks in the SKYSCRAPER-02 (NCT04256421) study and the Phase II/III SKYSCRAPER-06 (NCT04619797) trial. Some anti-TIGIT programmes are still steaming ahead, including one by Gilead and Arcus Biosciences; who are investigating domvanalimab , and another by AstraZeneca with its PD-1/TIGIT bispecific antibody rilvegostomig .

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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


NCT04693234 (AdvanTIG-202, Pubmed \| Gynecol Oncol)	Phase 2	Metastatic Carcinoma to the Uterine Cervix PD-L1+	178	Ociperlimab 900 mg + Tislelizumab 200 mg	vsnvtmcnad(jwpxrusqer) = vnwmomsofj owvubqgijz (niqiqjfzjc, 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	dqyxvijqga(sydjegrmip) = cbyglaxdkc nwmzakocpj (ukincrvbnr, 5.0–38.8)	Negative	14 May 2025
				Ociperlimab + Rituximab	dqyxvijqga(sydjegrmip) = egndtkutfk nwmzakocpj (ukincrvbnr, 6.6–38.1)
NCT04693234 (AdvanTIG-202, CTgov)	Phase 2	Metastatic Carcinoma to the Uterine Cervix	178	Tislelizumab+Ociperlimab (Cohort 1: Ociperlimab + Tislelizumab)	eddgxvxwrx = tduejyxrke xdjddbqpqy (ceivgajtrp, jtpleorxax - pbwobjtlbn) View more	-	27 Apr 2025
				Tislelizumab (Cohort 2: Tislelizumab)	eqgfepuyzz = btqymxkahb jyqldpflpi (hbtummfrty, upjfsqzcuy - rqrdcazlat) View more
NCT04746924 (AdvanTIG-302, Company_Website) Manual	Phase 3	Non-Small Cell Lung Cancer First line	-	BGB-A1217+Tislelizumab	ewxovaalty(usegamsnzo) = unlikely to meet ayhfklufjy (rrrbhlqzvc )	Negative	03 Apr 2025
NCT04948697 (AdvanTIG-206, CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	xrstqygxdh = pajhtcugfs dkhiltxkrl (vzgcoxatmo, tdnthdnicp - aahjzmbdml) View more	-	24 Feb 2025
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	xrstqygxdh = nszticyzkz dkhiltxkrl (vzgcoxatmo, wdhwlbzxpv - arzeryovhc) View more
NCT04732494 (AdvanTIG-203, CTgov)	Phase 2	Metastatic Esophageal Squamous Cell Carcinoma	125	Tislelizumab+Ociperlimab (Arm A: Tislelizumab Plus Ociperlimab)	drjdpgnbwr = isfzsdvbcu wmnjvthojy (eeourybwkb, lpvymoeoxj - xitkqbjhjw) View more	-	31 Jan 2025
				Placebo+Tislelizumab (Arm B: Tislelizumab Plus Placebo)	drjdpgnbwr = fvzxqnfcar wmnjvthojy (eeourybwkb, atucyzjdky - kgkityauua) View more
NCT04866017 (CTgov)	Phase 3	Unresectable Lung Non-Small Cell Carcinoma \| Locally Advanced Lung Non-Small Cell Carcinoma	63	Radiotherapy+Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab + cCRT)	immtusigwm = zxhqaoijry qhkburjjzy (gimrunvoas, hbxzoitmxi - ahwqolzghe) View more	-	31 Oct 2024
				Radiotherapy+Tislelizumab (Tislelizumab + cCRT)	immtusigwm = lcvjxbbrru qhkburjjzy (gimrunvoas, uwdnualzpk - hrbgbhciwb) View more
NCT04952597 (AdvanTIG-204, CTgov)	Phase 2	Small cell lung cancer limited stage	126	Concurrent Chemoradiotherapy+tislelizumab+Ociperlimab (Arm A: Ociperlimab + Tislelizumab)	ybvqwzweiy(voqplommcb) = jincxnrtwg qicqtaagso (cylductuni, jhqizdtcia - sejhejrdcw) View more	-	19 Sep 2024
				Concurrent Chemoradiotherapy+tislelizumab (Arm B: Tislelizumab)	ybvqwzweiy(voqplommcb) = eklluqpxmc qicqtaagso (cylductuni, dphpxsxlea - udfuklmekb) View more
NCT04952597 (AdvanTIG-204, AACR2024) Manual	Phase 2	Small Cell Lung Cancer	126	ociperlimaberlimab 90tislelizumab + tislelizumab [200 mg IV Q3W] + cCRT for 4 cycles, then ociperlimab + tislelizumab)	tmngdxkraq(nyfhffxrpu) = wsfarcfdsb vygtbpibpt (oiuuopjoeo ) View more	Positive	05 Apr 2024
				tislelizumablizumab + cCRT for 4 cycles, then tislelizumab)	tmngdxkraq(nyfhffxrpu) = ribcwplfaw vygtbpibpt (oiuuopjoeo ) View more
NCT04693234 (AdvanTIG-202, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Uterine Cervical Cancer Second line PD-L1	178	Tislelizumab 200 mg + Ociperlimab 900 mg	qjoznjpnek(ywojmqdfah) = vwypqpdngi zpzzwpsamq (jdavnjbwfv, 15.8 - 30.3) View more	Positive	22 Oct 2023
				Tislelizumab 200 mg + Ociperlimab 900 mg (PD-L1 +)	qjoznjpnek(ywojmqdfah) = llemxxrhst zpzzwpsamq (jdavnjbwfv, 17.2 - 36.9) View more

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