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Nuvalent Announces Positive Topline Pivotal Data from ALKOVE-1 Clinical Trial of Neladalkib for TKI Pre-treated Patients with Advanced ALK-positive NSCLC
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and
About this update from Nuvalent, Inc.
[{"type":"text","content":"\n \n In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively\n \n \n In the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively\n \n \n Neladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing design\n \n \n Company plans to discuss pivotal data for the TKI pre-treated ALK-positive NSCLC population with the FDA at a pre-NDA meeting; detailed study results are planned for presentation at a future medical meeting\n \n \n Company to host a conference call today, November 17th at 8:00am ET\n \n \n \n CAMBRIDGE, Mass., Nov. 17, 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 topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 clinical trial. Additionally, the company shared the first report of preliminary data from the Phase 2 exploratory cohort for TKI-naïve patients with advanced ALK-positive NSCLC from the ALKOVE-1 study.\n \n \n \n \n \n \n \n \"Today's announcement adds to the growing body of research that is transforming potential outcomes for ALK-positive lung cancer and offering new hope to patients,\" said Kirk Smith, patient and President of the Board of ALK Positive Inc. \"We encourage the continued innovation and development of new therapeutic options for patients, with the hope that one day, advanced ALK-positive NSCLC could be managed as a chronic condition more often than as a life-threatening disease.\"\n \"In treating ALK-positive lung cancer, our goal is not only to help patients live longer, but also to help them live well with their disease,\" said Alice T. Shaw, ...