On March 25, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be reported in a mini oral presentation at the European Lung Cancer Congress taking place March 26–29, 2025 in Paris, France (Press release, Nuvation Bio, MAR 25, 2025, View Source [SID1234651441]).
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Mini Oral Presentation Overview:
Title: Taletrectinib vs crizotinib in ROS1-positive non-small cell lung cancer: A matching-adjusted indirect comparison
Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine
Date: Thursday, March 27, 2025
Session Time: 4:00 p.m. – 5:05 p.m. CET / 11:00 a.m. – 12:05 p.m. ET
Session: Mini Oral Session 1
Presentation Number: LBA2
The materials will be made available in the Publications section of Nuvation Bio’s website after the presentation.
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 pooled 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.