Zhi Tong Cai Jing·2024-02-26 10:21Core Viewpoint - BeiGene's (06160) application for the marketing authorization of Tislelizumab has received a positive opinion from the European Medicines Agency (EMA) for treating three indications of non-small cell lung cancer (NSCLC) [1][2] Group 1: Approval and Indications - The EMA's Committee for Medicinal Products for Human Use (CHMP) recommends Tislelizumab for use in combination with chemotherapy for adult patients with locally advanced or metastatic squamous NSCLC [1] - The drug is also recommended for use in combination with pemetrexed and platinum-based chemotherapy for adult patients with locally advanced or metastatic non-squamous NSCLC who have specific genetic markers [1] - Tislelizumab can be used as a monotherapy for adult patients with locally advanced or metastatic NSCLC who have previously received platinum-based therapy [1] Group 2: Clinical Trials and Data - The marketing authorization application (MAA) is based on results from three Phase 3 clinical trials involving a total of 1,499 patients [1] - The results of the RATIONALE 307 and RATIONALE 304 studies, which evaluated Tislelizumab in combination therapies, were published in JAMA Oncology and Journal of Thoracic Oncology [1] - The RATIONALE 303 study, which assessed Tislelizumab as a monotherapy, was also published in the Journal of Thoracic Oncology [1] Group 3: Strategic Development and Market Impact - The positive opinion from CHMP marks another significant milestone for Tislelizumab, following its recent approval for treating advanced esophageal squamous cell carcinoma (ESCC) in the EU [2] - BeiGene is advancing Tislelizumab as both a monotherapy and combination therapy to address unmet needs in global patient populations [2] - Over 17 potential registration studies for Tislelizumab have been initiated, enrolling more than 13,000 patients, with 15 studies reporting positive data results [2]