Multicenter phase 2 trial of foritinib for advanced ROS1-rearranged non-small cell lung cancer

Currently approved targeted treatment for ROS1-rearranged advanced non-small cell lung cancer (aNSCLC) has either inadequate intracranial activity or CNS-related toxicities. The phase 2 SAF001 trial, at 29 centers in China, evaluated efficacy and safety of foritinib, a novel ALK and ROS1 inhibitor, in patients with ROS1-rearranged aNSCLC. Among patients who were ROS1-inhibitor-pretreated, the ORR to foritinib was 40% (95% CI 21-61). Among patients who were ROS1-inhibitor-naïve, the ORR to foritinib was 88% (95% CI 76-95), and among ROS1-inhibitor-naïve patients with baseline CNS metastases the ORR was 90% (70-99). Grade 3 or 4 treatment-related adverse events occurred in 32% of patients; there was no grade 5 TRAE. The authors conclude that foritinib showed systemic and intracranial antitumor activity and good tolerability in ROS1-inhibitor-naïve patients with ROS1-rearranged aNSCLC.