Innovent Publishes Phase 2 TRUST-I Study Data on Taletrectinib in JCO, Reports at 2024 ASCO Meeting

Innovent Biologics, Inc. (HKEX: 01801), a prominent biopharmaceutical enterprise, has unveiled the results of the pivotal Phase 2 TRUST-I study conducted in China, focusing on taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI). The study's findings were published in the Journal of Clinical Oncology (JCO) and will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The TRUST-I study evaluated 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) treated with taletrectinib. The results highlighted a tumor shrinkage (confirmed objective response rate, cORR) of 91% in TKI-naïve patients and 52% in those previously treated with crizotinib. Taletrectinib demonstrated significant efficacy in patients with brain metastases and those with acquired resistance mutations, including G2032R.

With a median follow-up of 23.5 months for TKI-naïve patients, the median duration of response and median progression-free survival were not reached. For TKI-pretreated patients, with a median follow-up of 9.7 months, the median duration of response was 10.6 months and median progression-free survival was 7.6 months. The safety profile of taletrectinib remained consistent with previous data, showing a low incidence of neurologic treatment-emergent adverse events (TEAEs).

Following the positive results from TRUST-I, the National Medical Products Administration (NMPA) of China has accepted two new drug applications (NDA) for taletrectinib and granted them priority review designations. These applications pertain to the first-line and second-line treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Caicun Zhou, M.D., Ph.D., Principal Investigator of the TRUST-I study, emphasized the need for new treatment options for ROS1-positive NSCLC, citing the strong efficacy and favorable safety profile of taletrectinib as promising for patients. Dr. Hui Zhou, Senior Vice President of Innovent Biologics, highlighted the clinical benefits and durable response shown by taletrectinib, reaffirming the company's commitment to working with regulatory authorities to bring this targeted therapy to patients in China.

ROS1-positive NSCLC is a subtype of non-small cell lung cancer, which affects over one million people globally each year. Approximately 1-3% of these patients are ROS1-positive. A significant proportion of these patients have brain metastases, underlining the need for effective treatments.

Taletrectinib, an oral and CNS-active ROS1 inhibitor, is designed for treating advanced ROS1-positive NSCLC. It's being evaluated in two Phase 2 pivotal studies: TRUST-I in China and TRUST-II globally. The U.S. Food and Drug Administration (FDA) and China's NMPA have granted Breakthrough Therapy Designations to taletrectinib for advanced or metastatic ROS1-positive NSCLC. Innovent's partnership with AnHeart Therapeutics aims to develop and commercialize taletrectinib in Greater China.

The TRUST-I study involved 173 patients, including TKI-naïve and TKI-pretreated groups. Patients received 600 mg of taletrectinib daily in 21-day cycles. The study's primary endpoint was cORR, with secondary endpoints including duration of response (DOR), progression-free survival (PFS), and safety. Results showed significant tumor and brain metastases shrinkage, particularly in TKI-naïve patients.

The study's detailed findings underscore the potential of taletrectinib as a new treatment option for ROS1-positive NSCLC, with promising response rates and manageable safety profiles. Innovent's dedication to providing innovative therapies continues to drive advancements in biopharmaceutical development, aiming to make high-quality treatments accessible globally.