Nuvalent Starts Phase 2 of ALKOVE-1 Trial for ALK-Positive NSCLC and Solid Tumors
Nuvalent, a biopharmaceutical firm, has commenced the Phase 2 stage of the ALKOVE-1 clinical trial for NVL-655, a novel ALK-selective tyrosine kinase inhibitor (TKI), after agreeing with the FDA on a daily dose of 150 mg. The drug is designed to address treatment resistance, brain metastases, and CNS adverse events associated with TRK inhibition. Phase 1 evaluated various doses in pre-treated patients with ALK-positive tumors, with the 150 mg dose showing stable plasma levels above efficacy thresholds without reaching a maximum tolerated dose.
Darlene Noci, Nuvalent's Chief Development Officer, highlighted the strategic design of Phase 2 to expedite clinical investigation for potential marketing approval, including a TKI-naïve cohort for early data generation. The CEO, James Porter, Ph.D., emphasized the importance of this milestone in their OnTarget 2026 plan, aiming to deliver targeted therapies and improve treatment paradigms.
The Phase 2 trial will be international, focusing on TKI pre-treated and TKI-naïve patients with ALK-positive NSCLC, as well as other ALK-positive solid tumors. The selection of the 150 mg dose was based on its efficacy, tolerability, and early anti-tumor activity. Nuvalent anticipates providing an update on the trial in 2024.
NVL-655 is intended to be active against resistant tumors, including those with ALK mutations like G1202R, and is designed to penetrate the CNS without inhibiting TRK, potentially avoiding CNS adverse events. It has received orphan drug status for ALK-positive NSCLC and is part of Nuvalent's pipeline targeting various cancer types.
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