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 nonclinical data for taletrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 25–30, 2025 in Chicago, Illinois (Press release, Nuvation Bio, MAR 25, 2025, View Source [SID1234651437]).
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Presentation Overview:
Title: Taletrectinib, a next generation selective ROS1 inhibitor, inhibits growth of ROS1 wild-type and ROS1-G2032R xenografts
Presenter: Hitisha Patel, Ph.D., Director of Research, Nuvation Bio
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 3
Date: Tuesday, April 29, 2025
Session Time and Location: 2:00 – 5:00 p.m. CT / 3:00 – 6:00 p.m. ET; Poster Section 20
Poster Board Number: 22
Abstract Number: 5612
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.