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Nuvalent to present cancer drug trial data at ASCO meeting

May 21, 2026 5:36 PM

Nuvalent Inc. (NASDAQ: NUVL) will present clinical trial data for two investigational cancer drugs at the American Society of Clinical Oncology Annual Meeting from May 29 to June 2, 2026, in Chicago.

The company will share pivotal data for neladalkib, an ALK-selective inhibitor, in patients with advanced ALK-positive non-small cell lung cancer who previously received tyrosine kinase inhibitor treatment. The data comes from the ALKOVE-1 Phase 1/2 clinical trial and supported Nuvalent's New Drug Application submission to the FDA in April 2026.

Dr. Jessica J. Lin from Mass General Brigham Cancer Institute will present the neladalkib data during an oral session on May 29. The presentation will detail efficacy and safety results from the global, single-arm registration-directed trial.

Nuvalent will also present preliminary data for zidesamtinib, a ROS1-selective inhibitor, in patients with advanced ROS1-positive solid tumors other than lung cancer. The data from the ARROS-1 Phase 1/2 trial includes 15 response-evaluable patients across 10 solid tumor types as of September 22, 2025.

Among the 15 patients treated with zidesamtinib, an objective response rate of 40% was observed. The majority of patients received the recommended Phase 2 dose of 100 mg once daily. Four of six responders remained on treatment as of the data cutoff date.

Dr. Benjamin Solomon from Peter MacCallum Cancer Centre will present the zidesamtinib data during a poster session on May 30.

Nuvalent previously announced topline pivotal data for neladalkib in November 2025. The FDA has accepted the company's NDA submission for zidesamtinib with a target action date of September 18, 2026, for treating patients with ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor.

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