Nuvalent Reports Positive Data From Phase 1/2 Trial of Zidesamtinib in Lung Cancer

MT Newswires Live

Jun 24, 2025

Nuvalent (NUVL) reported Tuesday positive data from its phase 1/2 clinical trial of zidesamtinib in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer, or NSCLC.

The company said 117 patients under the study demonstrated an objective response rate by blinded independent central review, or ORR by BICR, of 44% with an initial estimated durability of response of 78% at 12 months. A subset of 55 patients had a 51% ORR with an initial estimated durability of response of 93% at year one, the company added.

Zidesamtinib also demonstrated intracranial responses and activity against tumors, along with a well-tolerated safety profile, according to Nuvalent.

Nuvalent said it plans to start a rolling new drug application for zidesamtinib in July and targets completion in Q3.

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