A total of 161 patients with ROS-1 fusion positive locally advanced or metastatic NSCLC were enrolled in three ongoing phase I/II trials of entrectinib (ALKA 372-001, STARTRK-1 and STARTRK-2).rr
Median treatment duration was 10.7 months (IQR 6.4-17.7) with an objective response rate (ORR) in 108 patients (67.1%; 95% CI 59.3-74.3) with a complete response achieved in 8.7%, partial response in 58.4%, and stable disease in 8.7%.r The median progression free survival (PFS) was 15.7 months (95% CI 11.0-21.1) and 12 month overall survival (OS) rate was 81% (95% CI 74-87). Median OS and median time to CNS progression was not estimable. 38 (23.6%) patients died during follow-up.
In 24 patients with measurable baseline CNS metastases, the intracranial ORR was 79.2% (95% CI, 57.9-92.9). The median intracranial PFS was 12 months (95% CI 6.2-19.3) and the median intracranial duration of response was 12.9 months (95% CI 6.8-22.1).
Kaplan-Meier curves of (A) duration of response, (B) progression free survival, (C) time to CNS progression and (D) overall survivalr
© J Clin Oncol 2021