Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib

Core Insights - Nuvalent, Inc. is set to host a webcast and conference call on November 17, 2025, to discuss pivotal data for neladalkib, an investigational ALK-selective inhibitor for advanced ALK-positive non-small cell lung cancer [1][2] Company Overview - Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, specifically designed to overcome limitations of existing treatments for kinase targets [5] - The company is advancing a robust pipeline that includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs [5] Product Information - Neladalkib is designed to be a brain-penetrant ALK-selective inhibitor, aimed at overcoming resistance seen with current ALK inhibitors and improving treatment options for patients with brain metastases [3] - The drug has received FDA breakthrough therapy designation for patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors [3] Clinical Trial Details - The ALKOVE-1 trial is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer and other solid tumors, focusing on safety, tolerability, and preliminary anti-tumor activity [4] - The Phase 1 portion of the trial has been completed, and the ongoing Phase 2 portion is designed with registrational intent for TKI pre-treated patients [4]