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Nuvalent Highlights Upcoming Data Presentations for Neladalkib and Zidesamtinib at the 2026 American Society of Clinical Oncology Annual Meeting
Nuvalent Highlights Upcoming Data Presentations for Neladalkib and Zidesamtinib at the 2026 American Society of Clinical Oncology Annual
About this update from Nuvalent, Inc.
[{"type":"text","content":"Presentation of pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from ALKOVE-1 trialTKI pre-treated data from ALKOVE-1 trial of neladalkib support recent NDA submission and ongoing investigation in Phase 3 ALKAZAR trial for TKI-naïve patients with advanced ALK-positive NSCLCFirst presentation of encouraging preliminary data for zidesamtinib in patients with advanced ROS1-positive solid tumors other than NSCLC from ARROS-1 trialCAMBRIDGE, Mass., May 21, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today highlighted pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global, single-arm ALKOVE-1 Phase 1/2 clinical trial, and preliminary data in patients with advanced ROS1-positive solid tumors other than NSCLC from the global, single-arm ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1-selective inhibitor, to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago. \"The pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC enabled our recent NDA submission to the FDA, and represent important progress toward our goal of offering a new treatment option for this patient population,\" said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. \"Collectively, these data as well as preliminary data from the TKI-naïve cohort of our ALKOVE-1 study are supportive of further investigation of neladalkib in the global Phase 3 ALKAZAR trial of neladalkib compared to alectinib for TKI-naïve ALK-positive NSCLC, a critical step towards our ultimate goal of moving neladalkib up the treatment paradigm. We look forward to sharing these data with the medical community during an oral presentation at ASCO, and are deeply grateful to the patients, caregivers, and investigators who have made this milestone possible.\"\"These data build on the consistent characterization of neladalkib across preclinical and Phase 1 investigations,\" said Jessica J. Lin, M.D., Program ...