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Nuvalent Announces First Patient Dosed in ARROS-1 Phase 1/2 Clinical Trial of NVL-520, its Novel ROS1-selective Inhibitor

ARROS-1 trial enrolling patients with advanced ROS1-positive NSCLC and other solid tumors

Clinical development for parallel lead program, NVL-655, in ALK-positive cancers expected to begin in first half of 2022

Excerpt from the Press Release:

CAMBRIDGE, Mass., Jan. 7, 2022 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been dosed in ARROS-1, its Phase 1/2 clinical trial evaluating NVL-520 in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other advanced solid tumors. NVL-520, Nuvalent’s lead product candidate, is a novel ROS1-selective inhibitor designed to address the clinical challenges of emergent treatment resistance, CNS adverse events, and brain metastases that may limit the use of currently available ROS1 kinase inhibitors.

“The initiation of patient dosing with NVL-520 in ARROS-1 is a significant milestone for Nuvalent as we transition from a preclinical to clinical stage company,” said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. “We designed NVL-520 with the goal of fulfilling a specific target product profile developed in collaboration with leading physician-scientists who are actively treating patients with ROS1-driven cancers today. We are encouraged by the preclinical data generated to date, which provide evidence that NVL-520 represents a differentiated ROS1-selective inhibitor with the potential to overcome the limitations of current tyrosine kinase inhibitor therapies and provide a new therapeutic option for patients in need.”

ARROS-1 is a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-520 as an oral monotherapy. The Phase 1 dose-escalation portion of the study is open and enrolling patients with advanced ROS1-positive solid tumors who have been previously treated with at least one prior ROS1 tyrosine kinase inhibitor (TKI) therapy, and will evaluate the overall safety and tolerability of NVL-520 as well as determine the recommended Phase 2 dose (RP2D), characterize the pharmacokinetic profile, and evaluate preliminary anti-tumor activity.

Once a safe and tolerable dose is determined as the RP2D, the trial is designed to transition directly into the Phase 2 multiple cohort expansion portion, which will evaluate the overall activity of NVL-520 in patients with advanced ROS1-positive NSCLC and other advanced solid tumors. The Phase 2 portion will examine several cohorts of patients based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are designed to support potential registration in ROS1-positive patients with NSCLC who are kinase inhibitor-naïve and in those who have been previously treated with ROS1 kinase inhibitors.

“Nuvalent thoughtfully designed the ARROS-1 trial to support the goal of seamless acceleration from first-in-human dose-exploration of NVL-520 into Phase 2 cohorts that are structured to evaluate multiple opportunities for potential registration,” said Darlene Noci, A.L.M., Senior Vice President of Product Development & Regulatory Affairs for Nuvalent. “Through parallel evaluation of NVL-520 in TKI-naïve and clearly defined cohorts of pre-treated patients, we aim to generate data to comprehensively evaluate NVL-520 throughout the treatment paradigm for ROS1-driven cancers.”

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