NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced 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.
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.
About Nuvation Bio
Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, please visit www.nuvationbio.com or follow the Company on LinkedIn and X (@nuvationbioinc).
Contacts
Nuvation Bio Investor Contact:
ir@nuvationbio.com
Nuvation Bio Media Contact:
media@nuvationbio.com
