Innovent Biologics Reveals Breakthrough Data from Phase 2 TRUST-I Study of Taletrectinib at 2024 ASCO Annual Meeting
SAN FRANCISCO, U.S. and SUZHOU, China – Innovent Biologics, Inc. announced the publication of results from the pivotal Phase 2 TRUST-I study evaluating taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor, in the Journal of Clinical Oncology (JCO). The data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, showcased promising outcomes in the treatment of advanced ROS1-positive non-small cell lung cancer (NSCLC) patients with taletrectinib.
The study included 173 patients with advanced ROS1-positive NSCLC, with results indicating a significant tumor shrinkage rate of 91% in ROS1 TKI-naïve patients and 52% in ROS1 TKI-pretreated patients. Taletrectinib demonstrated strong activity in patients with brain metastases and acquired resistance mutations, including G2032R.
Furthermore, the safety profile of taletrectinib was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events. Based on the positive results of the TRUST-I study, two new drug applications for taletrectinib have been accepted by the Center for Drug Evaluation of the National Medical Products Administration of China for first-line and second-line treatment of ROS1-positive NSCLC.
Principal Investigator of the TRUST-I study, Dr. Caicun Zhou, emphasized the need for new treatment options for patients with advanced ROS1-positive NSCLC, highlighting the potential of taletrectinib to address this unmet medical need. Dr. Hui Zhou, Senior Vice President of Innovent Biologics, expressed optimism about the durable response and clinical benefits of taletrectinib for ROS1-positive NSCLC patients.
Taletrectinib is an oral, potent, selective ROS1 inhibitor designed for the treatment of advanced ROS1-positive NSCLC. It has been granted Breakthrough Therapy Designations by the U.S. FDA and China’s NMPA. The updated data from the TRUST-I study underscore the efficacy and safety of taletrectinib, positioning it as a potential new treatment option for patients with ROS1-positive NSCLC.
The results of the Phase 2 TRUST-I study mark a significant advancement in the field of oncology, offering hope to patients with ROS1-positive NSCLC who are in need of effective and well-tolerated treatment options. As research in this area continues to evolve, taletrectinib stands out as a promising therapy with the potential to improve outcomes for patients with this challenging disease.