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Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the
About this update from Nuvalent, Inc.
[{"type":"text","content":"Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial estimated durability of response of 78% at the 12-month landmark and 62% at the 18-month landmarkIn the subset of 55 patients treated with 1 prior ROS1 TKI (crizotinib or entrectinib) ± chemotherapy, ORR was 51% (95% CI: 37, 65) with initial estimated durability of response of 93% at the 12- and 18-month landmarksZidesamtinib demonstrated intracranial responses, activity against tumors with a ROS1 G2032R resistance mutation, and a generally well-tolerated safety profile, including low rates of dose reduction (10%) and discontinuation (2%), consistent with its ROS1-selective, TRK-sparing designCompany announces progress in the front-line development strategies for its parallel lead programs in ROS1-positive and ALK-positive NSCLCCompany to host a conference call today, June 24th at 8:00am ETCAMBRIDGE, Mass., June 24, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial.\n\n \n \n \n \n \n \n\n \nIn addition, Nuvalent announced progress on the front-line development strategies for its parallel lead programs in ROS1-positive and ALK-positive NSCLC, including:\nThe first report of preliminary data from the Phase 2 TKI-naïve cohort in its ARROS-1 clinical trial, in which global enrollment is ongoing; and,The advancement of clinical startup activities to support the global initiation of the ALKAZAR Phase 3, randomized, controlled trial. The trial is designed to evaluate neladalkib, a novel ALK-selective inhibitor, versus alectinib, a front-line standard of care, for the treatment of patients with TKI-naïve ALK-positive NSCLC...