TRIDENT-1: repotrectinib in ROS1 fusion-positive non-small-cell lung cancer
The next-generation ROS1 and TRK inhibitor repotrectinib shrank tumours in almost four in five untreated patients with ROS1-positive lung cancer, kept the disease under control for nearly three years, and worked in about four in ten patients after crizotinib including those with the resistant G2032R mutation.
Overview
Phase 1/2 study of 171 patients with ROS1 fusion-positive non-small-cell lung cancer treated with repotrectinib, including 71 who had not received a ROS1 inhibitor and 56 previously treated with one.
In ROS1 inhibitor-naive patients, objective response was 79 percent with median progression-free survival 35.7 months; in patients after one prior ROS1 inhibitor without chemotherapy, response was 38 percent with median progression-free survival 9.0 months, and 59 percent of G2032R-mutant tumours responded. Dizziness was the most frequent side effect.
- ROS1 inhibitor-naive: objective response 79 percent; median progression-free survival 35.7 months.
- After one prior ROS1 inhibitor: objective response 38 percent; 59 percent in G2032R-mutant tumours.
Repotrectinib is a preferred first-line ROS1 inhibitor because of its durability and coverage of resistance mutations, and it is also approved for NTRK fusion-positive tumours after prior TRK inhibitors.
- Single-arm; dizziness in about 60 percent and dysgeusia in half.
- No randomised comparison with crizotinib or entrectinib.
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