Nuvalent Reports Positive Pivotal Data From ARROS-1 Study Of Zidesamtinib

(RTTNews) - Nuvalent, Inc. (NUVL) Tuesday reported positive pivotal data from ARROS-1 Phase 1/2 study of zidesamtinib for the treatment of TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).

In 117 ROS1 TKI pre-treated patients, overall response rate (ORR) was 44% with durability of 78% at 12 months and 62% at 18 months. In patients treated with one prior ROS1 TKI, ORR was 51% with 93% durability at both 12 and 18 months.

The company plans to initiate a rolling NDA submission in July 2025 with completion targeted for the third quarter of 2025.