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
Innovent Biologics announced publication of Phase 2 TRUST-I study results in the Journal of Clinical Oncology and at the 2024 ASCO Annual Meeting. The study evaluated taletrectinib in 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). Tumor shrinkage was observed in 91% of ROS1 TKI-naïve and 52% of TKI-pretreated patients. Taletrectinib showed efficacy in treating brain metastases and resistance mutations. Median follow-up was 23.5 months for TKI-naïve and 9.7 months for TKI-pretreated patients. Median duration of response was not reached for TKI-naïve and was 10.6 months for TKI-pretreated. Two new drug applications have been accepted by China's NMPA with priority review. The safety profile showed low incidence of neurologic adverse events.
- 91% confirmed objective response rate (cORR) in ROS1 TKI-naïve patients.
- 52% cORR in ROS1 TKI-pretreated patients.
- Efficacy in treating brain metastases and resistance mutations.
- Median follow-up of 23.5 months for TKI-naïve patients without reaching median duration of response.
- Median duration of response of 10.6 months for TKI-pretreated patients.
- Two new drug applications accepted by China’s NMPA with priority review designation.
- Low incidence of neurologic treatment-emergent adverse events.
- Median progression-free survival for TKI-pretreated patients is only 7.6 months.
- Previous treatment with crizotinib shows lower response rates (52%) compared to TKI-naïve patients.
- Long-term efficacy data beyond median 23.5 months follow-up for TKI-naïve patients is not yet available.
Insights
The publication of the Phase 2 TRUST-I study results in the Journal of Clinical Oncology and their presentation at the ASCO Annual Meeting signal significant progress for Innovent Biologics. Taletrectinib's efficacy data, showing a 91% tumor shrinkage in ROS1 TKI-naïve patients and 52% in TKI-pretreated patients, is noteworthy. The inclusion of patients with brain metastases and those with acquired resistance mutations like G2032R adds to the robustness of the study. Additionally, the favorable safety profile with a low incidence of neurologic treatment-emergent adverse events (TEAEs) is promising. This could make taletrectinib a key player in treating ROS1-positive NSCLC, especially considering the limitations of current therapies. The median progression-free survival of 10.6 months in pretreated patients is also substantial, offering hope for durable responses where options have been limited.
From a financial perspective, the acceptance of two new drug applications (NDA) for taletrectinib by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and the priority review designations are critical milestones. This indicates a higher likelihood of market approval and could accelerate the drug's time to market, which is a positive signal for investors. The potential market for ROS1-positive NSCLC therapies is substantial and Innovent's strong clinical data positions them favorably against competitors. The announcement will likely boost investor confidence and could lead to an increase in the company's stock price, reflecting expectations of future revenue growth. However, investors should also be aware of the inherent risks, such as regulatory hurdles and competition from other pharmaceutical companies developing similar therapies.
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, underscoring its potential to become a new treatment option for patients."
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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