Multicenter phase 2 study of taletrectinib for ROS1+ non-small cell lung cancer: long-term results from TRUST-I

Taletrectinib is a next-generation, CNS-active, selective ROS1 TKI with activity against the ROS1 G203R resistance mutation. Initial results from the phase 2 TRUST-I study, at 4 centers in China, demonstrated high response rates and intracranial (IC) actitivity with promising durability in patients with advanced ROS1+ non-small cell lung cancer (NSCLC). Longer follow-up results from the trial have now been published. Talectrinib continued to demonstrate high and durable response rates in both TKI-naïve and crizotinib-pretreated patients. Among 103 TKI naive patients who started taletrectinib at 600 mg once daily (median follow-up 51.0 months) the objective response rate was 90.3%, the median duration of response was 49.7 months, the median progression-free survival was 49.6 months, and the median overall survival was not reached. Among 66 crizotinib-pretreated patients (median follow-up 45.2 months), the ORR was 51.5%, the median DOR was 13.2 months, the median PFS was 7.6 months, and the median OS was 25.6 months. The safety profile was consistent with prior reports. The authors conclude that talectrinib demonstrated durable long-term efficacy and a manageable safety profile in patients with advanced ROS1+ NSCLC.