Nuvalent, Inc. announced it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts. The presentation marks the first disclosure of data characterizing the safety and clinical activity of NVL-655 from the Phase 1 dose-escalation portion of the ongoing ALKOVE-1 phase 1/2 clinical trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-655 has been designed with the aim to address challenges that limit clinical use of existing ALK tyrosine kinase inhibitors (TKIs), including treatment emergent resistance mutations, lack of brain penetrance, and off-target CNS adverse events.

The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial. Nuvalent plans to host a conference call and webcast on October 13, 2023. NVL-655 has be observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients.

NVL-655 is currently being investigated in the ALKOVE-1 clinical trials (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK- positive non-small cell lung cancer and other solid tumors.