Innovent Announces Data from Pivotal Phase 2 TRUST-I Study of Taletrectinib（ROS1 Inhibitor) are Published in the JCO and Reported at 2024 ASCO Annual Meeting
Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. Results showed taletrectinib shrank tumors (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 91% of patients who were ROS1 TKI-naïve and 52% of patients who had previously been treated with crizotinib (ROS1 TKI-pretreated). Taletrectinib continued to show robust activity in patients with disease that spread to the brain, as well as in patients with acquired resistance mutations, including G2032R.
After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached. After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively. Taletrectinib's safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).
Based on positive results from the pivotal Phase 2 TRUST-I study, two new drug applications (NDA) of taletrectinib have been accepted by the
"Current treatments for advanced ROS1-positive NSCLC have significant limitations, and people living with this disease remain in need of new options that are both well tolerated and offer durable responses," said Caicun Zhou, M.D., Ph.D., Principal Investigator of the TRUST-I study and Professor and Director of the
Dr.
About ROS1-positive NSCLC
More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 1-3% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.
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 2 single-arm pivotal studies: TRUST-I (NCT04395677) in
In 2021, Innovent and AnHeart Therapeutics, a
About Phase 2 TRUST-I Study Results
TRUST-I (NCT04395677) is a pivotal Phase 2, multicenter, single-arm, open-label study evaluating taletrectinib as a monotherapy in 173 patients with advanced ROS1-positive NSCLC in
As of
In TKI-naïve patients (n=106):
- 90.6% of patients' tumors shrank in response to taletrectinib treatment (cORR).
- Taletrectinib shrank brain tumors in 87.5% of people who had measurable central nervous system tumors (n=8; intracranial cORR).
- After median follow-up of 23.5 months, median duration of response and median progression-free survival were not reached.
- At two years, 78.6% of patients who responded to taletrectinib treatment were still responding and 70.5% of patients were still progression-free.
In TKI-pretreated patients (n=66):
- 51.5% of patients' tumors shrank in response to taletrectinib treatment (cORR).
- Taletrectinib shrank brain tumors in 73.3% of people who had measurable central nervous system tumors (n=15; intracranial cORR).
- Taletrectinib shrank tumors in 66.7% of patients with G2032R mutations (n=12).
- After median follow-up of 9.7 months, median duration of response was 10.6 months and median progression-free survival was 7.6 months.
- At nine months, 69.8% of patients who responded to taletrectinib treatment were still responding and 47.4% were still progression-free.
Taletrectinib's safety profile was consistent with previous reports. The most frequent TEAEs were increased liver enzymes (increased aspartate aminotransferase: 76%; increased alanine aminotransferase: 68%); diarrhea (70%); vomiting (53%), and anemia (49%), most of which were grade 1 or 2. Incidence of neurologic TEAEs were low; the most common was dizziness (23%), most of which was grade 1. Discontinuations (5%) and dose reductions (19%) due to TEAEs were low.
The JCO publication, "Efficacy and Safety of Taletrectinib in Chinese Patients with ROS1+ Non-Small Cell
The corresponding oral presentation of the same name (Abstract #8520) will be delivered by Wei Li, M.D., a TRUST-I investigator and Professor at the
About
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte,
Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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