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Nuvalent Announces Anticipated Timing of Preliminary Phase 1 Dose-Escalation Data for NVL-655 and Reports First Quarter 2023 Financial Results
Preliminary dose-escalation data anticipated in second half of 2023 from ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced
About this update from Nuvalent, Inc.
[{"type":"text","content":"Preliminary dose-escalation data anticipated in second half of 2023 from ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors\nStrong financial position with expected operating runway into the second half of 2025\nCAMBRIDGE, Mass., May 11, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced plans to share preliminary data from the dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial for NVL-655, a novel ALK-selective inhibitor, in the second half of 2023, and reported first quarter 2023 financial results.\n\n \n \n \n \n \n \n\n \nALKOVE-1 is a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. The Phase 1 dose-escalation portion of the study is enrolling patients with previously treated ALK-positive solid tumors and will evaluate the overall safety and tolerability of NVL-655. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. Preclinical data, including those presented recently at the American Association for Cancer Research (AACR) Annual Meeting 2023, demonstrated that NVL-655 had broad preclinical activity across diverse ALK oncoproteins, single and compound resistance mutations, and tumor types while maintaining strong selectivity for ALK over TRKB and CNS penetrance.\n\"2023 is a year of focused, data-driven execution towards our goal of delivering a pipeline of novel kinase inhibitors to patients as efficiently as possible,\" said James Porter, Ph.D., Chief Executive Officer at Nuvalent. \"We plan to report preliminary data from our ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors in the second half of the year. We continue to enroll patients in the Phase 1 portion of the ARROS-1 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors in support of RP2D selection, and to advance NVL-330, our novel HER2-selective inhibitor for patients with HER2 exon 20 i...