Nuvalent presents data from ARROS-1 trial of zidesamtinib

Nuvalent (NUVL) presented data for zidesamtinib, a novel investigational ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer, NSCLC, from its global ARROS-1 Phase 1/2 clinical trial as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer, WCLC 2025, being held in Barcelona, Spain. The company is on track to complete its rolling NDA submission in the third quarter of 2025, and continues to engage with the FDA on potential opportunities for line-agnostic expansion. “There remains a clear need for new treatment options for patients with ROS1-positive NSCLC, particularly those who are unable to tolerate the currently available TKIs, and those whose disease progresses with brain metastases or resistance mutations,” said Christopher Turner, M.D., Chief Medical Officer at Nuvalent. “We are encouraged by the data presented today, which we believe highlight the potential of zidesamtinib to deliver meaningful outcomes with a generally safe and well-tolerated safety profile. These data represent important progress toward our goal of offering a new standard of care for this patient community. Congratulations to the entire Nuvalent team and our collaborators for the achievement of this important milestone.”