Express first-line treatment of esophageal cancer, BeiGene/Novartis PD-1 antibody combination therapy achieves the primary endpoint of Phase 3 clinical trials

▎WuXi AppTec content team editor Today, BeiGene and Novartis announced that the anti-PD-1 antibody tislelizumab (tislelizumab, Chinese brand name Bai Zean) in combination with chemotherapy, in the first-line treatment of advanced stage or met the primary endpoint in a phase 3 clinical trial in patients with metastatic esophageal squamous cell carcinoma (ESCC)
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An interim analysis showed that the combination of tislelizumab and chemotherapy significantly improved overall survival compared with chemotherapy
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Novartis plans to submit these data to regulatory agencies and to present detailed results at an upcoming medical meeting in collaboration with BeiGene
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ESCC is the most common esophageal cancer in the world, with an estimated over 600,000 newly diagnosed cases and over 540,000 deaths in 2020
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Tislelizumab, originally developed by BeiGene, is an anti-PD-1 monoclonal antibody that improves the anti-cancer immune response of T cells by blocking PD-1-mediated signaling pathways
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It has been approved by the National Medical Products Administration (NMPA) in China for the treatment of eight indications, including the most recent approval for patients with locally advanced or metastatic ESCC who have progressed or were not tolerated after prior first-line standard chemotherapy
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Image source: 123RF Novartis and BeiGene reached a research and development agreement to obtain the research and development and commercialization rights of tislelizumab in North America, Europe and Japan
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The company is evaluating tislelizumab in a variety of solid tumors in a clinical development program that includes 14 pivotal clinical trials
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Currently, the Biologics License Application (BLA) for tislelizumab in the second-line treatment of ESCC is under review by the US FDA
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"Esophageal cancer patients face painful challenges every day, and the prognosis is poor.
The 5-year survival rate of metastatic patients is only about 5%, which reflects the urgency of the need for more immunotherapy options.

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"We plan to discuss these data with regulatory agencies and will continue to expand the clinical development program of tislelizumab in an effort to discover innovative, synergistic combination therapies," said Jeff Legos, Novartis Global Head of Oncology and Hematology Development.
, prolonging the lives of more patients
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"Reference: [1] BeiGene Announces Global Phase 3 Clinical Trial of Baizean® Combined with Chemotherapy in First-Line Advanced Esophageal Squamous Cell Carcinoma Meets Primary Endpoint.
Retrieved April 27, 2022, from https:// com/story/359444-1.
shtml[2] Novartis tislelizumab plus chemotherapy significantly improved overall survival as first-line treatment for advanced esophageal cancer in Phase III study.
Retrieved April 27, 2022, from https:// /news/media-releases/novartis-tislelizumab-plus-chemotherapy-significantly-improved-overall-survival-first-line-treatment-advanced-esophageal-cancer-phase-iii-studyDisclaimer: WuXi AppTec Content Team Focused Introduction Global biomedical health research progress
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