WEEKEND NEWS
Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC, Supporting Planned New Drug Application Submission in the Fourth Quarter of 2024
Nuvation Bio (NYSE: NUVB) announced positive pooled data from TRUST-I and TRUST-II studies evaluating taletrectinib, a next-generation ROS1 TKI for advanced ROS1-positive NSCLC. Key findings include:
- 89% tumor shrinkage in TKI-naïve patients
- 56% tumor shrinkage in TKI-pretreated patients
- Median DOR of 44 months and PFS of 46 months in TKI-naïve patients
- Favorable safety profile with low neurologic TEAEs
- 89% tumor shrinkage in TKI-naïve patients
- 56% tumor shrinkage in TKI-pretreated patients
- Median DOR of 44 months and PFS of 46 months in TKI-naïve patients
- Favorable safety profile with low neurologic TEAEs
Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025. The data support taletrectinib's potential as a best-in-class treatment for ROS1-positive NSCLC.
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