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BeiGene (NASDAQ: BGNE) announced that results from the RATIONALE 309 trial evaluating tislelizumab with chemotherapy in nasopharyngeal cancer will be presented at the ESMO IO Congress from December 8-11, 2021. This interim analysis supports a regulatory submission in China for recurrent or metastatic nasopharyngeal cancer. Additionally, data from trials involving tislelizumab combined with the kinase inhibitor sitravatinib in melanoma and ovarian cancer will be shared, highlighting the company's commitment to developing effective immunotherapies and addressing unmet medical needs globally.
Positive
Presentation of RATIONALE 309 trial results supports regulatory submission in China for nasopharyngeal cancer.
Extensive clinical program with 13 Phase 3 and 4 pivotal Phase 2 trials, enhancing potential market presence.
Negative
None.
Results from RATIONALE 309 trial of tislelizumab in combination with chemotherapy in nasopharyngeal cancer will be presented in a proffered paper
Accepted abstracts also include new findings from clinical studies of tislelizumab andsitravatinib
CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--
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, today announced 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.
“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 IO, please visit https://beigenemedical.eu/.
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 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 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 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.
About BeiGene
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics 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 over 7,700 colleagues across 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 for development and commercialization of tislelizumab in nasopharyngeal carcinoma, ovarian cancer, melanoma and other solid tumors, plans for making tislelizumab accessible to patients, the potential for tislelizumab to be a differentiated anti-PD-1 antibody and to provide improved clinical benefits to patients, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “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 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 and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, and other operations, as well as 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.
What are the results of the RATIONALE 309 trial for BGNE?
The results of the RATIONALE 309 trial, evaluating tislelizumab in combination with chemotherapy for recurrent or metastatic nasopharyngeal cancer, will support regulatory submission in China.
When will BeiGene present its findings at the ESMO IO Congress?
BeiGene will present its findings at the ESMO IO Congress from December 8-11, 2021.
What is the significance of the tislelizumab and sitravatinib combination therapy?
The combination of tislelizumab with sitravatinib is being investigated to enhance treatment effectiveness in melanoma and platinum-resistant ovarian cancer.
How many clinical trials is BeiGene currently conducting?
BeiGene is currently involved in over 70 clinical trials, including 13 Phase 3 trials.
What are BeiGene's future plans regarding tislelizumab?
BeiGene aims to expand the clinical applications of tislelizumab in various cancers and enhance access to treatment options for patients globally.
