Nuvalent, Inc. (<NASDAQ: NUVL>) presented key data from its global ARROS-1 Phase 1/2 clinical trial at the IASLC 2025 World Conference on Lung Cancer (<WCLC 2025>) in Barcelona, Spain. The trial focused on zidesamtinib, a novel ROS1-selective inhibitor, in patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) previously treated with tyrosine kinase inhibitors (TKIs).
The data, initially revealed in June 2025, underpins Nuvalent‘s ongoing rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (<FDA>). The FDA accepted the NDA for its Real-Time Oncology Review (<RTOR>) program, expediting the review process. Nuvalent anticipates completing this submission by the third quarter of 2025. Discussions with the FDA are ongoing regarding potential broader application of the drug.
Nuvalent‘s Chief Medical Officer, Christopher Turner, M.D., expressed optimism about the findings. He highlighted the significant unmet need for new treatments in this patient population, particularly those with ROS1-positive NSCLC who don’t tolerate existing TKIs or experience disease progression with brain metastases or resistance mutations. Dr. Turner emphasized the potential for zidesamtinib to provide meaningful benefits with a favorable safety profile.
Zidesamtinib is a novel, brain-penetrant ROS1-selective inhibitor designed to address limitations of current ROS1 inhibitors. It aims to maintain effectiveness even in tumors resistant to existing treatments, including those with specific mutations. Furthermore, its design facilitates penetration of the central nervous system (CNS), addressing brain metastases and avoiding adverse events associated with related therapies. These characteristics may lead to durable responses across multiple treatment lines.
The ARROS-1 trial (NCT05118789) is a first-in-human Phase 1/2 study in patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 evaluated safety, tolerability, and determined the recommended Phase 2 dose. The ongoing Phase 2, a single-arm, open-label study, is designed with the intent of achieving registration for both TKI-naïve and TKI pre-treated patients with adva
Related
