Nuvalent Unveils Positive Zidesamtinib Data for Lung Cancer Trial, Pursuing New Standard of Care

Nuvalent (NUVL) presented promising data for zidesamtinib in a lung cancer trial, targeting ROS1-positive NSCLC patients. The company aims to complete its NDA by Q3 2025 and is discussing potential expansions with the FDA. Zidesamtinib has shown significant patient outcomes and an acceptable safety profile. Nuvalent continues to pursue its goal of establishing a new standard of care in this therapeutic area.

Nuvalent, Inc. (NUVL) has presented compelling data from its ARROS-1 clinical trial, showcasing the potential of zidesamtinib in treating advanced ROS1-positive non-small cell lung cancer (NSCLC). The company aims to complete its New Drug Application (NDA) submission by the third quarter of 2025, with the FDA's Real-Time Oncology Review (RTOR) program facilitating earlier submission of topline efficacy and safety results.

The pivotal data, initially announced in June 2025, highlight zidesamtinib's ability to deliver meaningful outcomes and a generally safe and well-tolerated safety profile in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive NSCLC. The drug has shown promise in overcoming resistance to currently available ROS1 inhibitors, including those with treatment-emergent ROS1 mutations such as G2032R, and demonstrates potential for deep, durable responses in patients with brain metastases.

Nuvalent's Chief Medical Officer, Christopher Turner, M.D., emphasized the need for new treatment options for ROS1-positive NSCLC patients who are unable to tolerate existing TKIs or whose disease progresses with brain metastases or resistance mutations. The company is optimistic about the data presented, which represent significant progress towards establishing a new standard of care in this therapeutic area.

Zidesamtinib, a novel brain-penetrant ROS1-selective inhibitor, is currently being investigated in the ARROS-1 Phase 1/2 clinical trial. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who had previously received at least one ROS1 TKI, while the ongoing Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.

Nuvalent's pipeline includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. The company continues to engage with the FDA on potential opportunities for line-agnostic expansion of zidesamtinib.

Nuvalent's forward-looking statements include the expected timing of data announcements and NDA submissions, the clinical development program for zidesamtinib, and the potential benefits and effects of its product development candidates. The company acknowledges the risks associated with drug development, including the potential for clinical trial enrollment delays, unexpected safety events, and regulatory approval timelines.

References:
[1] https://www.prnewswire.com/news-releases/nuvalent-presents-pivotal-data-from-arros-1-clinical-trial-of-zidesamtinib-for-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-at-wclc-2025-302548220.html
[2] https://www.morningstar.com/news/pr-newswire/20250907ne67220/nuvalent-presents-pivotal-data-from-arros-1-clinical-trial-of-zidesamtinib-for-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-at-wclc-2025