Nuvalent Inc. announced preliminary results from the ongoing ALKOVE-1 Phase 1/2 clinical trial evaluating neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC). The early data, which will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, show an objective response rate of 44% among 34 response-evaluable patients across 14 different solid tumor types. The trial includes both ALK TKI-naïve and ALK TKI pre-treated patients. Global enrollment in the Phase 2 cohort is ongoing for adult and adolescent patients with advanced ALK-positive solid tumors beyond NSCLC.
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