Nuvalent to Present Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC at WCLC 2025 Presidential Symposium

Core Insights - Nuvalent, Inc. announced pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, targeting advanced ROS1-positive non-small cell lung cancer (NSCLC) patients, which will be presented at the IASLC 2025 World Conference on Lung Cancer [1][2] - The company has initiated a rolling NDA submission for zidesamtinib, with the FDA agreeing to accept the NDA for the Real-Time Oncology Review pilot program, aiming for completion in Q3 2025 [2][3] Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, specifically for clinically proven kinase targets [5][6] - The company leverages expertise in chemistry and structure-based drug design to create innovative small molecules that address treatment resistance and minimize adverse events [6] Product Details - Zidesamtinib is designed to be a brain-penetrant ROS1-selective inhibitor, effective against tumors that have developed resistance to existing ROS1 inhibitors, including those with treatment-emergent mutations [3][4] - The ARROS-1 Phase 1/2 clinical trial is investigating zidesamtinib in patients with advanced ROS1-positive NSCLC, with the Phase 1 portion focusing on safety and tolerability [4]