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Nuvalent Initiates the Phase 2 Portion of ARROS-1 Clinical Trial for Patients with ROS1-Positive NSCLC and other Solid Tumors
Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily CAMBRIDGE, Mass., Sept. 5, 2023 /PRNewswire/ --
About this update from Nuvalent, Inc.
[{"type":"text","content":"Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily\nCAMBRIDGE, Mass., Sept. 5, 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 the initiation of the Phase 2 portion of ARROS-1, its Phase 1/2 clinical trial of NVL-520 for patients with ROS1-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 100 mg daily.\n\n \n \n \n \n \n \n\n \nNVL-520 is a novel brain-penetrant ROS1-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, off-target central nervous system (CNS) adverse events associated with TRK inhibition, and brain metastases that may limit the use of currently available ROS1 TKIs.\n\"The ARROS-1 trial was designed to support a seamless transition from first-in-human dose-exploration in a heavily pre-treated population to a Phase 2 portion designed with the potential to support registration. We are thrilled to achieve this milestone towards our goal of bringing a potential best-in-class therapy to patients with ROS1-positive NSCLC as efficiently as possible,\" said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent.\n\"The Phase 2 portion of the ARROS-1 trial includes multiple cohorts which enable the parallel investigation of NVL-520 for patients with ROS1-positive NSCLC who are either TKI naïve or pre-treated with a ROS1 TKI,\" Ms. Noci continued. \"Support for the Phase 2 cohort design includes the demonstrated nonclinical activity of NVL-520 in the periphery and in the CNS, and its selective inhibition of ROS1 and ROS1 drug-resistance mutant G2032R over the structurally-related TRK kinases. Combined with the broad clinical activity and favorable tolerability observed to date in heavily pre-treated patients in the Phase 1 portion of ARROS-1, we believe there is the potential for NVL-520 to provide durable responses while minimizing adverse events and dose limiting toxicities for patients with ROS1-positive cancers throughout the treatment paradigm.\"\nIn the Phase 1 portion of ARROS-1, six do...