On May 21, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that additional results from TRUST-I and TRUST-II, its pivotal Phase 2 clinical studies on the efficacy and safety of taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting taking place May 30–June 3, 2025, in Chicago, Illinois (Press release, Nuvation Bio, MAY 21, 2025, View Source [SID1234653281]).
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"Taletrectinib is a highly selective, next-generation oral tyrosine kinase inhibitor, with the potential to expand what’s possible for patients with ROS1-positive non-small cell lung cancer," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We look forward to presenting data from our pivotal TRUST-I and TRUST-II clinical studies, which further demonstrate the potential efficacy and safety of taletrectinib in patients across ethnicities and regions of the world. With a PDUFA date and potential approval by the U.S. FDA in just over a month, we are looking forward to hopefully bringing a truly meaningful new option to patients living with this disease."
Presentation Overview:
Title: Comparable efficacy and safety of taletrectinib for advanced ROS1+ non–small cell lung cancer across pivotal studies and between races and world regions
Presenter: Maurice Perol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France
Date: Saturday, May 31, 2025
Session Time: 1:30-4:30 p.m. CT
Abstract Number: #8643
Location: Poster #123
The materials will be made available in the Publications section of Nuvation Bio’s website after the session. To learn more about Nuvation Bio, visit Booth #28031 at the ASCO (Free ASCO Whitepaper) Annual Meeting.
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.