Zai Lab announces NEJM published data from TRIDENT-1 study

Zai Lab announced The New England Journal of Medicine, or NEJM, has published data from the registrational Phase 1/2 TRIDENT-1 study evaluating repotrectinib in patients with ROS1 fusion-positive non-small cell lung cancers, or NSCLCs. Repotrectinib is a tyrosine kinase inhibitor, or TKI, that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models. In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naive and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases. Treatment with repotrectinib was generally well tolerated with a manageable safety profile compatible with long-term administration. Turning Point Therapeutics, a wholly owned subsidiary of the Bristol-Myers Squibb Company, sponsored and designed the global, registrational TRIDENT-1 study. In August 2022, Bristol Myers Squibb acquired the company, including its asset repotrectinib. As part of its exclusive license agreement with Turning Point Therapeutics to develop and commercialize repotrectinib in Greater China, Zai Lab participated and enrolled 81 patients for this trial. Every year in China, more than 800,000 people are newly diagnosed with lung cancer, and NSCLC accounts for approximately 85% of the cases. ROS1 rearrangements occur in less than or equal to2% of patients with NSCLC1. Brain metastases are common among patients with ROS1+ NSCLC and intracranial activity of approved ROS1 TKIs can be suboptimal.