On March 23, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported an upcoming poster presentation for the ongoing Phase 1/2 ALKOVE-1 study of its ALK-selective inhibitor, NVL-655 (Press release, Nuvalent, MAR 23, 2023, View Source [SID1234629267]). The poster will be presented at the European Lung Cancer Congress (ELCC 2023), taking place in Copenhagen, Denmark, and virtually, March 29 – April 1, 2023.

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The "Trial in Progress" poster includes background and study design considerations for the ALKOVE-1 Phase 1/2 study (NCT05384626) evaluating the safety and preliminary activity of NVL-655 in patients with solid tumors harboring oncogenic ALK alterations, including those with acquired ALK resistance mutations and CNS metastases. The first-in-human, multicenter, open-label, dose-escalation and expansion study is currently evaluating NVL-655 as an oral monotherapy in the Phase 1 portion.

The poster will be archived on the Nuvalent website at www.nuvalent.com following the presentation.

Details for the poster presentation are as follows:

Title: NVL-655, a Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor, in Patients with Advanced ALK-Positive Solid Tumors: The Phase 1/2 ALKOVE-1 Study
Authors: Melissa Johnson1, Sai-Hong Ignatius Ou2, Enriqueta Felip3, Christina Baik4, Benjamin Besse5, Julien Mazieres6, D. Ross Camidge7, Shirish Gadgeel8, Alexander Drilon9, Yasir Elamin10, Geoffrey Liu11, Joshua E. Reuss12, Tina Kehrig13, Henry E. Pelish13, Viola Zhu13, Jessica J. Lin14
Presentation Number: 81TiP
Abstract Category: Advanced NSCLC
Session Date and Time: Friday, March 31, 2023 from 12:00 – 12:45pm CEST
Location: Bella Center Copenhagen, Exhibition and Poster Area

1Sarah Cannon Research Institute, Nashville, TN, United States of America, 2University of California Irvine Medical Center, Orange, CA, United States of America, 3Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain, 4Fred Hutchinson Cancer Center, Seattle, WA, United States of America, 5Institut Gustave Roussy, Villejuif, France, 6Institut Universitaire du Cancer, Toulouse, France, 7University of Colorado Cancer Center – Anschutz Medical Campus, Aurora, CO, United States of America, 8Henry Ford Cancer Institute, Detroit, MI, United States of America, 9Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY, United States of America, 10MD Anderson Cancer Center, Houston, TX, United States of America, 11Princess Margaret Cancer Center, Toronto, Ontario, Canada, 12Georgetown University, Washington, DC, United States of America, 13Nuvalent, Inc., Cambridge, MA, United States of America, 14Massachusetts General Hospital, Boston, MA, United States of America

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 study (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.