Business
Nuvalent Initiates the Phase 2 Portion of ALKOVE-1 Clinical Trial for Patients with ALK-Positive NSCLC and other Solid Tumors
Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for
About this update from Nuvalent, Inc.
[{"type":"text","content":"Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily\nPhase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive NSCLC and Enables Preliminary Evaluation in the TKI-naïve Setting\nCAMBRIDGE, Mass., Feb. 12, 2024 /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 the initiation of the Phase 2 portion of ALKOVE-1, its Phase 1/2 clinical trial of NVL-655 for patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors, following alignment with the US Food and Drug Administration (FDA) on a recommended Phase 2 dose (RP2D) of 150 mg once daily (QD).\n\n \n \n \n \n \n \n\n \nNVL-655 is a novel brain-penetrant ALK-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events associated with inhibition of the structurally-related tropomyosin receptor kinase (TRK) family that may limit the use of currently available ALK TKIs.\nIn the Phase 1 portion of ALKOVE-1, six dose levels (15 mg to 200 mg QD) of NVL-655 were evaluated in heavily pre-treated patients with ALK-positive solid tumors, and a maximum tolerated dose was not reached. The RP2D of 150 mg QD maintained steady state plasma levels above target efficacy thresholds (ALK wild type fusions and ALK single and compound mutations in both the periphery and in the CNS).\n\"The transition of our NVL-655 program into Phase 2 advances a second, parallel opportunity towards our goal of bringing potential best-in-class therapies to patients as efficiently as possible,\" said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. \"This sense of urgency is reflected in the thoughtful design of the Phase 2 portion of the ALKOVE-1 trial which aims to accelerate the clinical investigation that may support a potential marketing application towards an initial approval for previously treated patients with ALK-positive NSCLC. The Phase 2 portion also includes a TKI-naïve cohort which may provide an opportunity to generate early data, and could be conducted in parallel with...