Pooled results of two phase 2 studies of talectrectinib for ROS1-positive non-small cell lung cancer

Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 tyrosine kinase inhibitor (TKI). The phase 2 studies TRUST-I (China) and TRUST-II (global) evaluated taletrectinib for ROS1 positive non-small cell lung cancer. Patients received taletrectinib 600 mg once daily. Pooled results of the studies have now been published. Among the TKI-naïve patients the confirmed objective response rate and intracranial response rate were 88.8% and 76.5%, respectively; among TKI-pretreated patients they were 55.8% and 65.6%, respectively. Among TKI-naïve patients, the median duration of response and median progression-free survival were 44.2 and 45.6 months, respectively; among TKI-pretreated patients, they were 16.6 and 9.7 months, respectively. Most frequent treatment-emergent adverse events were grade 1. TEAEs resulted in discontinuation in 6.5% of patients. The authors conclude that taletrectinib showed a high response rate with durable responses, robust intracrinial activity, and favorable safety among TKI-naïve and pretreated patients with ROS1-positive NSCLC.