Innovent Announces Taletrectinib（ROS1 Inhibitor）Updated Data from Pivotal Phase 2 TRUST-I Study of are Published in the JCO and Orally Presentedat 2024 ASCO Annual Meeting
Innovent Biologics announced updated data from its pivotal Phase 2 TRUST-I study of taletrectinib, a next-generation ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting. The study involved 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in China. Results showed a 91% confirmed objective response rate (cORR) in ROS1 TKI-naïve patients and a 52% cORR in those previously treated with crizotinib. Taletrectinib demonstrated favorable outcomes in patients with brain metastases and resistance mutations. The median duration of response and progression-free survival were not reached in TKI-naïve patients after a median follow-up of 23.5 months, while TKI-pretreated patients had a median duration of response of 10.6 months and median progression-free survival of 7.6 months. The safety profile was consistent with previous reports. Two new drug applications have been accepted for priority review by China's NMPA.
- Taletrectinib showed a 91% cORR in ROS1 TKI-naïve patients.
- 52% cORR in patients previously treated with crizotinib.
- Demonstrated robust activity in patients with brain metastases and resistance mutations.
- Median duration of response and progression-free survival not reached in TKI-naïve patients.
- Safety profile consistent with previous reports, with low incidence of neurologic TEAEs.
- Two NDAs accepted by China's NMPA for priority review.
- Median duration of response for TKI-pretreated patients was only 10.6 months.
- Median progression-free survival for TKI-pretreated patients was 7.6 months.
Insights
The TRUST-I study results for taletrectinib present significant implications for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). The study demonstrates a high objective response rate (cORR) of
The publication of the TRUST-I study in the Journal of Clinical Oncology (JCO) and its presentation at the ASCO Annual Meeting underscore the significance of these findings. The study provides compelling evidence of taletrectinib's efficacy, particularly in its ability to target intracranial metastases and overcome resistance mutations like G2032R. From a research perspective, the fact that median DoR and PFS have not been reached in TKI-naïve patients after a median follow-up of indicates durable responses. This is a critical advantage over existing therapies, offering hope for prolonged remission. The acceptance of two new drug applications (NDAs) and their priority review status by the NMPA in China highlight the strategic regulatory advancements, which could accelerate the drug's market entry and availability to patients.
The positive results from the TRUST-I Phase 2 study are likely to bolster Innovent Biologics' market position. The acceptance of the two NDAs and their priority review designation by the NMPA suggest a high likelihood of market approval, which could translate into significant revenue growth. The data showing taletrectinib's effectiveness in both first-line and second-line treatments, particularly in TKI-naïve patients, positions it as a potentially market-leading product in the NSCLC segment. For retail investors, this development could signal a promising growth trajectory for Innovent, especially if the drug receives approval and gains market traction. Moreover, the robust efficacy and favorable safety profile could drive higher adoption rates, further enhancing market share and long-term financial performance.
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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
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 Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of
"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 Department of Oncology at Shanghai East Hospital, Tongji University. "These TRUST-I results reinforce taletrectinib's strong efficacy and favorable safety profile, with longer follow-up, taletrectinib continues to show high and durable overall responses, robust intracranial and G2032R activity, with a low incidence of neurologic AEs. We look forward to taletrectinib benefits ROS1-positive NSCLC patients in the near future."
Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, " The updated data of the TRUST-I study shows remarkably durable response and meaningful clinical benefits of taletrectinib for ROS1-positive NSCLC patients. We will continue close communications with our partner and regulatory authorities in
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
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 Nuvation Bio (NYSE: NUVB) Company, entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in
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 November 29, 2023, results from TRUST-I as assessed by an IRC showed:
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 and70.5% 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 and47.4% were still progression-free.
Taletrectinib's safety profile was consistent with previous reports. The most frequent TEAEs were increased liver enzymes (increased aspartate aminotransferase:
The JCO publication, "Efficacy and Safety of Taletrectinib in Chinese Patients with ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study," is available at https://ascopubs.org/journal/jco.
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 Department of Medical Oncology at Shanghai East Hospital, Tongji University, at the 2024 ASCO Annual Meeting in the "Lung Cancer – Non-Small Cell Metastatic" session occurring today, Saturday, June 1, 2024, at 4:30-6:00 p.m. CT/5:30-7:00 p.m. ET.
About Innovent Biologics:
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, Adimab, LG Chem and MD Anderson Cancer Center.
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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FAQ
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