Nuvalent reports preliminary Phase 1 clinical data from ARROS-1 trial

Nuvalent announced the initial data from the Phase 1 dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive non-small cell lung cancer, NSCLC, and other solid tumors. As of the preliminary data cut-off date of September 13, 2022, no dose-limiting toxicities, treatment-related serious adverse events, treatment-emergent dizziness, or adverse events leading to treatment reductions or discontinuations were observed. Preliminary activity data reported as of the data cut-off date were available from 21 heavily pre-treated response-evaluable NSCLC patients, of which partial responses were observed in 48%. To evaluate key target characteristics of NVL-520, activity was examined in subgroups including: Patients with ROS1 G2032R mutations - Objective Response Rate, ORR, 78%, 7/9; Patients with a history of CNS metastases - ORR 73%, 8/11; The most heavily pre-treated of patients, receiving two or more prior ROS1 TKIs and one or more prior lines of chemotherapy - ORR 53%, 9/17; and Patients previously treated with lorlatinib or repotrectinib - ORR 50%, 9/18. As of the preliminary data cut-off date, 76% of response-evaluable patients continued on NVL-520 treatment. Enrollment in the Phase 1 portion of the trial is ongoing. "We believe today's preliminary results further support Nuvalent's approach of applying innovative chemistry and structure-based drug design to well-defined target product profiles focused on addressing medical needs that have been identified in collaboration with leading physician-scientists," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "Not only has this approach rapidly delivered the encouraging preliminary results for NVL-520 presented today, it underpins our work across our entire pipeline, including parallel lead candidate NVL-655 for ALK-positive NSCLC, and our recently announced development candidate for HER2ex20-driven cancers, NVL-330"