ZAI LAB(US:ZLAB) Businesswire·2024-01-10 22:12Core Insights - Zai Lab Limited announced the publication of data from the Phase 1/2 TRIDENT-1 study in the New England Journal of Medicine, evaluating repotrectinib in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) [1][4] - Repotrectinib demonstrated high response rates and durable activity in both treatment-naïve and treatment-resistant patients, including those with brain metastases [1][3] - The drug has been granted Breakthrough Therapy Designations in China for various patient categories, indicating its potential significance in treating ROS1-positive metastatic NSCLC [6] Company Overview - Zai Lab is a biopharmaceutical company focused on developing innovative products for oncology, autoimmune disorders, infectious diseases, and neuroscience [7] - The company has an exclusive license agreement with Turning Point Therapeutics to develop and commercialize repotrectinib in Greater China [6][7] Study Details - The TRIDENT-1 study involved 519 patients, with primary endpoints including maximum tolerated dose and confirmed objective response rate [3] - The study's results support the efficacy of repotrectinib in addressing limitations of first-generation TKIs for ROS1+ NSCLC [3] Market Context - In China, over 800,000 new lung cancer cases are diagnosed annually, with NSCLC accounting for approximately 85% of these cases [2] - ROS1 rearrangements occur in ≤2% of NSCLC patients, highlighting a niche but critical market for targeted therapies like repotrectinib [2]