Nuvalent, Inc. has presented pivotal data for zidesamtinib, a novel investigational ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from its global ARROS-1 phase 1/2 clinical trial.
The presentation was given at the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona, Spain.
The pivotal data presented, initially announced in June 2025, serve as the foundation for the company’s ongoing rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC.
The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) programme, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application. 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, 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.”
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