Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

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Nuvalent announced positive pivotal data from the ARROS-1 Phase 1/2 trial for zidesamtinib (a ROS1-selective inhibitor) in previously treated ROS1-positive non-small cell lung cancer (NSCLC) patients125.

The overall objective response rate (ORR) reported was 44% in 117 patients heavily pretreated with tyrosine kinase inhibitors (TKIs); in a subset of 55 patients who had only one prior ROS1 TKI, the ORR was 51%25.

The drug demonstrated notable durability:
78% of all responders maintained their response at 12 months, and 62% at 18 months. Among patients with brain metastases, the intracranial ORR was 48%5.

Nuvalent plans to initiate a rolling New Drug Application (NDA) submission to the FDA in July 2025, targeting completion in the third quarter of 2025, in alignment with the FDA's Real-Time Oncology Review program145.

The patient population studied is considered highly refractory, with many having already received two or more prior ROS1 TKIs, including newer brain-penetrant agents2.

Sources:

1. https://investors.nuvalent.com/2025-06-24-Nuvalent-Announces-Positive-Pivotal-Data-from-ARROS-1-Clinical-Trial-of-Zidesamtinib-for-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC

2. https://www.fiercebiotech.com/biotech/competitive-pivotal-data-nuvalent-eyes-fda-rolling-submission-crowded-lung-cancer-niche

4. https://investors.nuvalent.com/image/Nuvalent+OverviewJune+24,+2025vFINAL.pdf

5. https://www.investing.com/news/company-news/nuvalent-plans-fda-submission-for-lung-cancer-drug-zidesamtinib-93CH-4107514