Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting
Tumors shrank in 91% of taletrectinib-treated patients with advanced ROS1-positive NSCLC who were ROS1 TKI-naïve and 52% of those who were ROS1 TKI-pretreated in the study
Responses were durable with long-term follow-up; 71% of TKI-naïve patients were still progression-free at two years
TRUST-I is one of two registrational Phase 2 studies evaluating taletrectinib for the treatment of patients with advanced ROS1-positive NSCLC
Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib. Results showed tumors shrank (confirmed objective response rate, cORR, as assessed by an independent review committee, IRC) in 91% of taletrectinib-treated patients who had not previously been treated with a ROS1 TKI (ROS1 TKI-naïve) and 52% of taletrectinib-treated 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).
“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
“TRUST-I is one of the largest prospective trials conducted to date in ROS1-positive NSCLC. We now have data with long-term follow-up and are very pleased that results remain highly consistent with previously reported taletrectinib data, demonstrating its best-in-class potential,” said
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 following treatment with taletrectinib (cORR).
- Brain tumors shrank in 87.5% of taletrectinib-treated patients 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 following treatment with taletrectinib were still responding, and 70.5% of patients were still progression-free.
In TKI-pretreated patients (n=66):
- 51.5% of patients’ tumors shrank following treatment with taletrectinib (cORR).
- Brain tumors shrank in 73.3% of taletrectinib-treated patients who had measurable central nervous system tumors (n=15; intracranial cORR).
- Tumors shrank in 66.7% of taletrectinib-treated 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 following treatment with taletrectinib 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, “Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1+ Non-Small Cell
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,
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
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, the potential for taletrectinib to become a new therapeutic option for ROS1-positive NSCLC, taletrectinib’s best-in-class therapeutic potential, the expected timing of establishing a commercial organization, and the expected timing for sharing results from the TRUST-II study. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of
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