FDA Grants Taletrectinib Priority Review in ROS1+ Advanced NSCLC
The FDA has granted priority review to the NDA seeking the approval of taletrectinib (AB-106) for the treatment of patients with ROS1-positive advanced NSCLC. Data from a pooled analysis of the phase 2 TRUST-1 (NCT04395677) and TRUST-II (NCT04919811) trials presented at the 2024 ESMO Congress support this review. Taletrectinib led to a confirmed overall response rate (ORR) of 88.8% (95% CI, 82.8%-93.2%) among treatment-naive patients (n = 160). In those previously treated with a ROS1 tyrosine kinase inhibitor (TKI; n = 113), the confirmed ORR was 55.8%. Patients with the ROS1 G2032R mutation (n = 13) within the previously treated cohort achieved a 61.5% confirmed ORR.
Trials and Results
The trials enrolled adult patients with locally advanced or metastatic ROS1-positive NSCLC, including those with stable central nervous system (CNS) involvement. All patients received taletrectinib at a dose of 600 mg once daily. According to David Hung, MD, founder, president, and chief executive officer of Nuvation Bio, "We are thrilled to reach this important milestone for taletrectinib, a significant step forward for people living with ROS1-positive NSCLC who urgently need new treatment options." With data from over 300 patients, taletrectinib has demonstrated the potential to deliver durable and meaningful benefits.
Additional results from the TKI-naive cohort showed that at a median follow-up of 21.2 months, the median progression-free survival (PFS) was 45.6 months, and the median duration of response (DOR) was 44.2 months. For CNS activity, the intracranial ORR (IC-ORR) was 76.5% among evaluable patients. In the TKI-pretreated cohort at a median follow-up of 21.0 months, the median PFS was 9.7 months, and the median DOR was 16.6 months. The confirmed IC-ORR in this group of 32 evaluable patients was 65.6%.
Safety and Adverse Events
In terms of safety, the treatment showed a high incidence of treatment-emergent adverse events (TEAEs). Among evaluable patients, 99.7% experienced any-grade TEAEs, and 51.6% had grade 3 or higher TEAEs. Common AEs included liver enzyme elevations, diarrhea, and nausea. TEAEs led to dose reductions and treatment discontinuation in a percentage of patients.
The NDA is currently under review by the FDA, with a target decision date set for June 23, 2025.
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