Nuvation Bio Announces Positive Pooled Data from the Pivotal Phase 2 TRUST-I ... - MarketScreener
Nuvation Bio announced positive pooled data from Phase 2 TRUST-I and TRUST-II studies on taletrectinib, a next-gen ROS1 TKI, to be presented at ESMO 2024. The analysis highlights taletrectinib's efficacy and safety, with median duration of response at 44 months and progression-free survival at 46 months in TKI-naive patients. The data supports Nuvation Bio's planned NDA submission in the U.S., with taletrectinib granted Orphan Drug and Breakthrough Therapy Designations by the U.S. FDA and China's NMPA for ROS1+ NSCLC treatment.
Related Clinical Trials
Reference News
Nuvation Bio announced positive pooled data from TRUST-I and TRUST-II studies evaluating taletrectinib, a next-generation ROS1 TKI for advanced ROS1-positive NSCLC, showing 89% tumor shrinkage in TKI-naïve patients and 56% in TKI-pretreated patients, with a median DOR of 44 months and PFS of 46 months in TKI-naïve patients. The drug also demonstrated a 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.
Nuvation Bio announced positive pooled data from Phase 2 TRUST-I and TRUST-II studies on taletrectinib, a next-gen ROS1 TKI, to be presented at ESMO 2024. The analysis highlights taletrectinib's efficacy and safety, with median duration of response at 44 months and progression-free survival at 46 months in TKI-naive patients. The data supports Nuvation Bio's planned NDA submission in the U.S., with taletrectinib granted Orphan Drug and Breakthrough Therapy Designations by the U.S. FDA and China's NMPA for ROS1+ NSCLC treatment.