BeiGene to Present New Clinical Data on Tislelizumab at ESMO IO Congress 2021

On December 2, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that clinical results and updates from its diverse immuno-oncology portfolio will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2021 being held December 8-11, 2021 (Press release, BeiGene, DEC 2, 2021, View Source [SID1234596410]).

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"Despite recent advances in immuno-oncology, chemotherapy remains the standard of care for many patients living with cancer around the world. We look forward to presenting findings on the potential of our anti-PD-1 antibody tislelizumab to treat nasopharyngeal cancer, a rare cancer that is more common in underserved areas of the world, as well as in melanoma and ovarian cancer," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Our R&D team, one of the largest oncology R&D teams in the world, is exploring novel combinations and mechanisms of action around the PD-1 axis to identify potential synergies and overcome PD-1 resistance, as we work to increase access to innovative medicines for patients with limited treatment options."

To learn more about BeiGene’s research and development and activities at ESMO (Free ESMO Whitepaper) IO, please visit View Source

Broad Clinical Program to Address Unmet Needs

To bring forth potential new treatment options and uncover further insights into checkpoint inhibition in solid tumors and hematological malignancies, BeiGene is evaluating tislelizumab, a potentially differentiated anti-PD-1 antibody, in a broad clinical program, including 13 Phase 3 trials and four pivotal Phase 2 trials, and in collaboration with Novartis.

At ESMO (Free ESMO Whitepaper) IO, results from an interim analysis of the randomized, double-blind, Phase 3 RATIONALE 309 trial (NCT03924986) evaluating tislelizumab in combination with chemotherapy in recurrent or metastatic nasopharyngeal cancer (RM-NPC) will be presented in a Proffered Paper. These results supported the regulatory submission in China for NPC.

Novel Combination Therapies to Expand Clinical Benefit of Anti-PD-1 Antibodies

Combination strategy is considered key to overcoming primary and acquired resistance to anti-PD-1 therapy and expanding clinical benefit of immunotherapy to more patients. BeiGene is investigating the potential of novel tislelizumab combinations to drive stronger and more sustained tumor responses and impede tumor immune escape. At ESMO (Free ESMO Whitepaper) IO, results from two cohorts of a Phase 1b trial (NCT03666143) evaluating tislelizumab in combination with the oral, spectrum-selective kinase inhibitor sitravatinib in metastatic melanoma and platinum-resistant ovarian cancer will be presented. BeiGene is developing sitravatinib in collaboration with Mirati Therapeutics, Inc.

Additionally, BeiGene will share details on the design of the Phase 3 AdvanTIG-301 trial (NCT04866017) evaluating its investigational Fc-competent anti-TIGIT-antibody ociperlimab in combination with tislelizumab and concurrent chemoradiotherapy (eCRT) as a first-line treatment for patients with locally advanced, unresectable non-small cell lung cancer.

BeiGene’s Presentations at ESMO (Free ESMO Whitepaper) IO Congress 2021

Presentation Information

Date and Time

Lead Author

121O—RATIONALE 309: A randomized, global, double-blind, Phase 3 trial of tislelizumab versus placebo, plus gemcitabine + cisplatin, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Proffered Paper Session 2

Fri, Dec 10 at 9 AM CET

Yunpeng Yang

156P—BGB-900-103 Cohort G: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with PD-(L)1-refractory/ resistant unresectable or metastatic melanoma from a Phase 1b study

ePoster Display: Therapeutic Development

Thu, Dec 9 at 11:30 AM CET

Chuanliang Cui

153P—BGB-900-103 Cohort E: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer

ePoster Display: Therapeutic Development

Thu, Dec 9 at 10:30 AM CET

Jeffrey Goh
144P—Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer (TD-NICE): a single arm, phase II study

ePoster Display: Therapeutic Development

Thu, Dec 9 at 7:30 AM CET

Xiaolong Yan

148P—A Phase II Study of tislelizumab plus chemotherapy in EGFR mutated advanced non-squamous NSCLC patients failed to EGFR TKI therapies: first analysis

ePoster Display: Therapeutic Development

Thu, Dec 9 at 8:50 AM CET

Baohui Han

167TiP—AdvanTIG-301: Anti-TIGIT monoclonal antibody ociperlimab plus tislelizumab plus concurrent chemoradiotherapy followed by ociperlimab plus tislelizumab or tislelizumab plus concurrent chemoradiotherapy followed by tislelizumab versus concurrent chemoradiotherapy followed by durvalumab in previously untreated, locally advanced, unresectable non-small cell lung cancer

ePoster Display: Therapeutic Development

Thu, Dec 9 at 3:10 PM CET

Ligang Xing

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 70 clinical trials involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 45 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.