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BEIJING, China and CAMBRIDGE, Mass.
Advanced colorectal cancer patients with disease progression after prior fluorouracil, oxaliplatin, and irinotecan therapy; other advanced solid tumor patients with disease progression after prior therapy and no satisfactory alternative treatment options
Mark Lanasa, MD, Senior Vice President and Chief Medical Officer of Solid Tumors at BeiGene, said: "The clinical trial results of Baizean® in patients with MSI-H and dMMR solid tumors demonstrate that the indicators for each tumor type and various clinical endpoints are Baizean® has shown consistent and long-lasting therapeutic effects
Dr.
"In this pivotal Phase 2 trial, we observed tislelizumab The efficacy in different tumor types is consistent and generally well tolerated.
The approval is based on the results of a single-arm, multicenter, open-label, pivotal Phase 2 clinical trial (NCT03736889) designed to evaluate the use of Bazaar monotherapy in previously treated, locally advanced unresectable or Efficacy and safety in patients with metastatic MSI-H or dMMR solid tumors
About microsatellite highly unstable or mismatch repair gene-deficient solid tumors
Microsatellite highly unstable (MSI-H) cancer cells have more genetic markers than normal cells, and these genetic markers are called "microsatellites," short, repetitive DNA sequences
About Baizean® (Tislelizumab Injection)
Baizean® (Tislelizumab Injection) is a humanized IgG4 anti-programmed death receptor 1 (PD-1) monoclonal antibody designed to minimize interaction with macrophages.
The National Medical Products Administration (NMPA) of China has approved Baizean in seven indications, including full approval of Baizean in combination with chemotherapy for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC), Baizean ® combined with chemotherapy for the treatment of first-line advanced non-squamous NSCLC patients, and Bai Zean® for the treatment of second- or third-line locally advanced or metastatic NSCLC patients with disease progression after previous platinum-containing chemotherapy.
In addition, two new indication marketing applications for Baizean are under review by the NMPA Center for Drug Evaluation (CDE), including one for the treatment of locally advanced or intolerable patients who have progressed or are not tolerated after prior first-line standard chemotherapy.
The U.
BeiGene has initiated or completed 17 registrational clinical trials of BeiGene® in China and globally, including 13 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials
In January 2021, BeiGene and Novartis entered into a cooperation agreement to authorize Novartis to develop, manufacture and commercialize Baizean® in North America, Europe and Japan
Bai Zean® has not yet been approved in countries or regions other than China
About the clinical research and development project of Baizean® (Tislelizumab Injection)
Phase 3 clinical trial of the safety and efficacy of tislelizumab versus docetaxel in second- or third-line treatment of patients with non-small cell lung cancer (clinicaltrials.
(clinicaltrials.
Source: BeiGene
