Overview

• ARROS-1 investigators reported in 117 previously treated patients an objective response rate of 44% with a 12-month duration-of-response rate of 78%, with nearly half having CNS disease.
• In patients who had received one prior ROS1 TKI (n=55), the ORR was 51% and DOR rates at 6, 12, and 18 months were each 93%, with no progression events among prior-crizotinib responders.
• Intracranial efficacy included an 83% intracranial response rate with four complete responses and no CNS progression events at the data cutoff.
• Preliminary results in TKI-naive patients (n=35) showed an 89% response rate and a 12-month DOR rate of 96%.
• Safety was generally manageable, with peripheral edema, constipation, CPK increase, fatigue, and dyspnea most common; dose reductions occurred in 10% of patients and discontinuations in 2%.