Innovent Announces Updated Taletrectinib Data in JCO and at 2024 ASCO Annual Meeting

Innovent Biologics, Inc., a prominent biopharmaceutical company headquartered in San Francisco and Suzhou, China, has revealed significant findings from its pivotal Phase 2 TRUST-I study conducted in China. The study assessed the efficacy of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), in treating advanced ROS1-positive non-small cell lung cancer (NSCLC). These results were published in the Journal of Clinical Oncology and will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The TRUST-I study involved 173 patients with advanced ROS1-positive NSCLC. The results indicated that taletrectinib was effective in shrinking tumors in 91% of patients who had not previously been treated with ROS1 TKIs and in 52% of those who had previously been treated with crizotinib. Additionally, the drug showed substantial activity in patients with brain metastases and those with resistance mutations, including the G2032R mutation.

For TKI-naïve patients, taletrectinib demonstrated impressive results with a confirmed objective response rate (cORR) of 90.6%. The median duration of response and progression-free survival were not reached after a median follow-up period of 23.5 months. For TKI-pretreated patients, the cORR was 51.5%, with a median duration of response of 10.6 months and a median progression-free survival of 7.6 months after a median follow-up of 9.7 months. Notably, taletrectinib's efficacy extended to patients with brain metastases and those with the G2032R mutation, with intracranial cORR rates of 87.5% and 73.3%, respectively.

Taletrectinib's safety profile was consistent with previous reports, featuring a low incidence of neurologic treatment-emergent adverse events (TEAEs), with dizziness being the most common at 23%. Other frequent TEAEs included increased liver enzymes, diarrhea, vomiting, and anemia. The incidence of severe side effects leading to discontinuation or dose reduction was low.

The promising results of the TRUST-I study have led to the acceptance of two new drug applications (NDAs) for taletrectinib by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. These applications, which have been granted priority review designations, pertain to the first-line and second-line treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Dr. Caicun Zhou, the Principal Investigator of the TRUST-I study, emphasized the strong efficacy and favorable safety profile of taletrectinib, noting its robust and durable responses, especially in patients with brain metastases and G2032R mutations. Dr. Hui Zhou, Senior Vice President of Innovent Biologics, highlighted the meaningful clinical benefits of taletrectinib and expressed optimism about bringing this new targeted therapy to ROS1-positive NSCLC patients in China.

ROS1-positive NSCLC is a subtype of non-small cell lung cancer, which affects 1-3% of NSCLC patients. This subtype is particularly challenging to treat, especially when it metastasizes to the brain, which occurs in up to 35% of newly diagnosed cases and 55% of cases following initial treatment.

Taletrectinib is an oral, potent, central nervous system-active, selective ROS1 inhibitor designed for advanced ROS1-positive NSCLC. It is being evaluated in two Phase 2 pivotal studies: TRUST-I in China and TRUST-II, a global study. Taletrectinib has received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China's NMPA.

In 2021, Innovent partnered with AnHeart Therapeutics to co-develop and commercialize taletrectinib in Greater China. Innovent Biologics, established in 2011, is dedicated to developing and commercializing high-quality biopharmaceuticals, with a focus on treating cancer, cardiovascular, metabolic, autoimmune, and eye diseases. The company collaborates with over 30 global healthcare entities and has launched multiple products in the market with several others in various stages of regulatory review and clinical trials.