On September 18, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR (Free AACR Whitepaper)-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts (Press release, Nuvalent, SEP 18, 2023, View Source [SID1234635219]).
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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. Details for the conference call will be provided at a future date and available on the Nuvalent website at www.nuvalent.com.
Details for the presentation are as follows:
Title: Safety and preliminary activity of the selective ALK inhibitor NVL-655 in patients with ALK fusion-positive solid tumors
Abstract Number: 35177
Poster Number: B154
Session: Poster Session B
Session Date and Time: Friday, October 13, 12:30 pm-4:00 pm
Presenting Author: Jessica J Lin, Massachusetts General Hospital (MGH), Boston, MA
About NVL-655
NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been 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 trial (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.