Neladalkib Demonstrates Promising Results in Advanced ALK-Positive lung Cancer Trial
November 17, 2025 – Nuvalent, Inc. announced positive topline data from the pivotal ALKOVE-1 clinical trial evaluating neladalkib, an investigational oral selective tyrosine kinase inhibitor (TKI), in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have progressed on prior TKIs. The findings reveal durable responses and a manageable safety profile, offering a potential new treatment option for a patient population with limited alternatives.
This breakthrough addresses a critical unmet need for individuals with ALK-positive NSCLC whose cancer has become resistant to existing TKIs. Approximately 5% of NSCLC cases harbor ALK fusions, and while initial TKIs provide significant benefit, resistance inevitably develops.Neladalkib’s unique design aims to overcome common resistance mechanisms, potentially extending progression-free survival and improving outcomes for these patients. The data released today will be closely watched by the oncology community as it informs future treatment strategies and the potential for neladalkib’s approval.
The ALKOVE-1 trial assessed neladalkib in patients with advanced ALK-positive NSCLC who had previously received one or more ALK TKIs. Nuvalent reported that neladalkib demonstrated encouraging anti-tumor activity, with a preliminary overall response rate and duration of response that warrant further examination. Detailed results,including progression-free survival and overall survival data,are expected to be presented at a future medical conference and submitted for publication.
Recent insights into the complexities of EGFR mutations and ALK fusions in early-stage NSCLC, as detailed in pharmacy Times on June 19, 2025, underscore the importance of targeted therapies like neladalkib. Understanding these genomic drivers is crucial for personalized treatment approaches and maximizing patient benefit.
