Nuvation Bio Advances with Pooled Data for ROS1-positive Lung Cancer Treatment, Eyes FDA Submission

Efficacy:
Taletrectinib, a next-generation ROS1 TKI, showed significant tumor shrinkage in patients with advanced ROS1-positive NSCLC, with 89% tumor reduction in TKI-naïve patients and 56% in TKI-pretreated patients.

Clinical Trials:
The TRUST-I and TRUST-II studies provided pooled data that highlighted taletrectinib's best-in-class potential for treating ROS1-positive NSCLC, with a median duration of response (DOR) of 44 months and progression-free survival (PFS) of 46 months in TKI-naïve patients.

Safety Profile:
Taletrectinib demonstrated a favorable safety profile with low neurologic treatment-emergent adverse events (TEAEs).

Regulatory Submission:
Nuvation Bio plans to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2024, aiming for a U.S. launch in 2025.

Designations:
Taletrectinib has received Orphan Drug Designation from the FDA for treating ROS1-positive NSCLC and Breakthrough Therapy Designations from both the FDA and China’s NMPA for advanced or metastatic ROS1-positive NSCLC.

Clinical Need:
ROS1-positive NSCLC is a significant unmet need, with limited treatment options available for patients, particularly those with brain metastases.