Presentation of new data from pivotal phase II clinical studies of taletrectinib, a novel ROS1 inhibitor, in patients with advanced ROS1-positive Non-Small Lung Cancer at ASCO 2025
2025/06/02Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Atsuhiro Wakumoto; hereinafter "Nippon Kayaku") announces that additional results from the two Phase 2 pivotal clinical studies (TRUST-I and TRUST-II) of taletrectinib (development code: AB-106) were presented at American Society of Clinical Oncology (ASCO) 2025 Annual Meeting.
TRUST-I and TRUST-II studies have been conducted in various regions worldwide for the purpose of applying manufacturing and marketing approval in multiple countries, and the main results of these studies were positive, as reported in international scientific conferences and published papers. In order to confirm the safety and efficacy data are consistent across different ethnicities and regions, the efficacy and safety of taletrectinib within and between the pivotal regional TRUST-I and global TRUST-II studies were compared through subgroup analyses. The results were presented at ASCO 2025 annual meeting on May 31 2025 (Eastern Standard Time)
Please refer to Nuvation Bio Inc’s website for details on the presented content.
https://nuvationbio.com/wp-content/uploads/2025/05/ASCO-Taletrectinib-TRUST-I-and-TRUST-II-Poster.pdf
The pivotal cohorts (ROS1 TKI-naïve and ROS1 TKI-pretreated) of TRUST-I and TRUST-II had similar study designs, which included the same primary endpoint and secondary endpoints, as well as similar inclusion/exclusion criteria and safety evaluation methods. Key efficacy and safety profiles were compared in 3 ways: (a) across Western (North America and Europe) and Asian regions, and racial subgroups, in the pooled study population of TRUST-I and TRUST-II, (b) between TRUST-I and TRUST-II, and (c) between Western and Asian regions and other subgroups in the global TRUST-II study. Relative risk and associated 95% confidence intervals via the Wald method were used to compare data.
The subgroup analysis showed that the main safety and efficacy profiles were consistent between the two pivotal studies and demonstrated consistency across races and regions in the combined population.
In the comparison targeting the TRUST-II study, the confirmed overall response rate, the primary efficacy endpoint, was favorable regardless of region, chemotherapy history, or race, and the main safety profile was similar among Asian and Western patients, as well as among different races.
Nippon Kayaku will continue its efforts to obtain marketing authorization for taletrectinib in Japan to provide a new treatment options for patients with advanced ROS1-positive NSCLC.
Reference information
Outline of Nuvation Bio Inc.
(1) Name: Nuvation Bio Inc.
(2) Headquarters: 1500 Broadway, Suite 1401, New York, NY 10036
(3) Representative and CEO: David Hung, M.D.
(4) Established: 2018
(5) Fiscal Year End: December 31
(6) Main Business: Biotechnology
(7) Number of employees (including affiliates): 273 as of March 31, 2025
(8) Past relationship with Nippon Kayaku: Capital, personal and business relationships have not previously occurred.
About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients’ lives. Their pipeline indicates taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor.
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.
About ROS1 gene fusion
ROS1 is an enzyme protein called tyrosine kinase that is involved in cell growth. ROS1 gene fusion is formed by the fusion of the ROS1 gene and a part of a partner gene. ROS1 gene fusion has been confirmed in various cancers, including NSCLC, and the proliferation of cancer cells can be suppressed by suppressing the function of ROS1.
About ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1-positive disease. Up to 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. 1-3 Despite recent progress for patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable treatment options.
1. Journal of Clinical Oncology. 2012 Mar 10; 30 (8):863-70.
2. Journal of Thoracic Oncology. 2018 Jul 5; 13 (11):1717–1726
3. Lung Cancer. 2019 Apr: 130:201-207.
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-positive NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase II single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.
The results from the TRUST-I study, which was conducted in China were presented at the American Society of Clinical Oncology (ASCO) 2024. The results from the TRUST-II study, which enrolled almost a quarter of patients in Japan, were presented at WCLC 2024. The pooled results from the TRUST-I and TRUST-II studies were presented at the European Society for Medical Oncology (ESMO) 2024 and published in Journal of Clinical Oncology (Journal of Clinical Oncology. 2025 Apr 3:JCO2500275. doi: 10.1200/JCO-25-00275).
Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC (line agnostic, full approval) and assigned a Prescription Drug User Fee Act (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-positive NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications. In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. In Japan Nippon Kayaku announced that submission of a marketing authorization application for taletrectinib had been completed on March 3, 2025.
Please visit Nuvation Bio’s website to refer to the detailed data presented at past scientific conferences. https://www.nuvationbio.com/publications/
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