BeiGene to present new clinical data on Tislelizumab at ESMO IO 2021 congress

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December 2, 2021 08:00 UTC

CAMBRIDGE, Massachusetts and BEIJING – (COMMERCIAL THREAD) – BeiGene (NASDAQ: BGNE; HKEX: 06160), a global science-based biotechnology company focused on the development of innovative and affordable drugs to improve treatment outcomes and access for patients around the world, announced today hui that clinical results and updates from its diverse portfolio of immuno-oncology will be presented at the 2021 congress of the European Society for Medical Oncology and Immuno-Oncology (ESMO IO) to be held from 8 to 11 December 2021.

“Despite recent advances in immuno-oncology, chemotherapy remains the standard of care for many cancer patients around the world. We look forward to presenting results 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 cancer of the nasopharynx. ovary, ”commented Yong (Ben) Ben, MD, 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 resistance to PD. -1, 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 IO, please visit https://beigenemedical.eu/.

Extensive clinical program to address unmet needs

To provide potential new treatment options and uncover new information on checkpoint inhibition in solid tumors and hematologic malignancies, BeiGene is evaluating tislelizumab, a potentially differentiated anti-PD-1 antibody, in the context of a large clinical program, comprising 13 phase 3 trials and four pivotal trials. Phase 2 trials, and in collaboration with Novartis.

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

New Combination Therapies to Extend the Clinical Benefits of Anti-PD-1 Antibodies

The combination strategy is considered essential to overcome primary and acquired resistance to anti-PD-1 therapy and extend the clinical benefits of immunotherapy to a larger number of patients. BeiGene is investigating the potential of novel combinations of tislelizumab to generate stronger and more sustained tumor responses and prevent tumor immune evasion. At ESMO IO, results from two cohorts of a phase 1b trial (NCT03666143) evaluating tislelizumab in combination with the selective spectrum 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 the design details of the AdvanTIG-301 Phase 3 trial (NCT04866017) evaluating its investigational anti-TIGIT-TIGIT antibody ociperlimab in combination with tislelizumab and concomitant chemoradiation therapy (eCRT) as treatment. first-line for patients with locally advanced and unresectable non-small cell lung cancer.

BeiGene presentations at the ESMO IO 2021 congress

Presentation information

Date and time

Principal author

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

Proposed document Session 2

Fri 10 Dec at 9:00 a.m. CET

Yunpeng Yang

156P — BGB-900-103 Cohort G: Safety / tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with unresectable or metastatic melanoma refractory to PD- (L) 1 / resistant 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 anti-tumor 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 in combination with chemotherapy as a neoadjuvant treatment for surgically resectable esophageal cancer (TD-NICE): a phase II single-arm 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 patients with advanced non-squamous cell NSCLC mutated with EGFR who did not receive EGFR TKI therapy: first review

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 concomitant chemoradiotherapy followed by ociperlimab plus tislelizumab or tislelizumab plus concomitant chemoradiotherapy followed by tislelizumab versus concomitant topically untreated chemoradiotherapy previously untreated previously untreated durvalumab

EPoster display: Therapeutic development

Thu. Dec. 9 at 15:10 CET

Ligang Xing

BeiGene Oncology

BeiGene is committed to advancing the best clinical candidates internally or with like-minded partners to develop impactful and affordable drugs for patients around the world. 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 healthy patients and volunteers. Our extensive portfolio is led by a predominantly in-house clinical development team that supports trials in more than 45 countries. Hematology-oncology and targeted therapies against solid tumors and immuno-oncology are key areas of intervention for the Company, with monotherapies and combination therapies being a priority in our research and development. We are currently marketing three drugs discovered and developed in our laboratories: the BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and other international markets; and the FC-gamma receptor non-binding anti-PD-1 antibody, tislelizumab and the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies that share our goal of developing therapies to meet global health needs. We market a range of oncology drugs in China under license from Amgen and Bristol Myers Squibb. We also plan to address larger 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 the rights to develop, manufacture and market tislelizumab in North America, Europe and Japan.

About BeiGene

BeiGene is a science-driven global biotechnology company focused on the development of innovative and affordable medicines to improve treatment outcomes and access for patients around the world. With a large portfolio of over 40 clinical candidates, we are accelerating the development of our diverse portfolio of new therapies through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of more than 7,700 colleagues on five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

Forward-looking statements

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 plans to develop and commercialize tislelizumab in nasopharyngeal cancer, ovarian cancer, melanoma and other solid tumors, plans to make tislelizumab available to patients, the potential of tislelizumab to be a differentiated anti-PD-1 antibody and to provide better clinical benefits to patients, and the plans, commitments, aspirations and objectives of BeiGene under the titles “BeiGene Oncology” and “About BeiGene”. Actual results may differ materially from those shown in forward-looking statements due to various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results of its drug candidates, which may not support further development or marketing authorization; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and market approval; BeiGene’s ability to achieve commercial success for its marketed drugs and drug candidates, if approved; BeiGene’s ability to obtain and maintain intellectual property protection for its drugs and technology; BeiGene’s dependence on third parties for drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceuticals and its ability to obtain additional funding for its operations and complete the development and commercialization of its drug candidates and to achieve and maintain profitability ; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial and other operations, as well as the risks discussed in more detail in the section titled “Risk Factors” in BeiGene’s latest 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 United States Securities and Exchange Commission. All information contained in this press release is as of the date of this press release, and BeiGene does not undertake to update this information, except as required by law.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211202005063/en/


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