The US Food and Drug Administration has accepted for priority review the new drug application for repotrectinib for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Repotrectinib is an oral tyrosine kinase inhibitor (TKI) that targets ROS1– or NTRK-positive locally advanced or metastatic solid tumors. The new drug application is supported by data from the TRIDENT-1 trial (ClinicalTrials.gov Identifier: NCT03093116), which was designed to evaluate the anti-tumor activity and safety of repotrectinib in patients with advanced solid tumors, including NSCLC.
The study included 4 NSCLC expansion cohorts: ROS1 TKI-naïve patients (cohort 1); patients previously treated with 1 ROS1 TKI and 1 platinum-based chemotherapy (cohort 2); patients previously treated with 2 ROS1 TKIs and no chemotherapy (cohort 3); and patients previously treated with 1 ROS1 TKI and no prior chemotherapy (cohort 4).
The objective response rate (the primary endpoint) was 79% in cohort 1, 42% in cohort 2, 28% in cohort 3, and 38% in cohort 4. Repotrectinib demonstrated durable responses in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations.
The most commonly reported treatment-emergent adverse events included dizziness, dysgeusia, constipation, anemia, paresthesia, dyspnea, fatigue, nausea, and increased alanine transaminase.
A Prescription Drug User Fee Act target date of November 27, 2023, has been set for the application.
US Food and Drug Administration accepts for Priority Review Bristol Myers Squibb’s application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. News release. Bristol Myers Squibb. Accessed May 30, 2023.
Cho BC, Lin J, Camidge DR, et al. Pivotal topline data from the phase 1/2 TRIDENT-1 trial of repotrectinib in patients with ROS1+ advanced non-small cell lung cancer (NSCLC). Eur J Cancer. Published online October 28, 2022. doi:10.1016/S0959-8049(22)00812-7
This article originally appeared on MPR