Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• In ROS1 fusion-positive Non-Small Cell Lung Cancer (NSCLC) patients who had not previously received a ROS1 Tyrosine Kinase Inhibitor (TKI), the objective response rate (ORR) was 79% (95% Confidence Interval (CI), 68 to 88), while patients who had received one ROS1 TKI showed an ORR of 38% (95% CI, 25 to 52). For patients with the ROS1 G2032R mutation, the ORR was 59% (95% CI, 33 to 82).
• The median duration of response (DOR) for ROS1 fusion-positive NSCLC patients without prior ROS1 TKI treatment was 34.1 months (95% CI, 25.6 to not estimated). For patients who had received one ROS1 TKI, the median DoR was 14.8 months (95% CI, 7.6 to not estimated).
• The median progression-free survival (PFS) was 35.7 months (95% CI, 27.4 to not estimated) in patients without prior ROS1 TKI treatment and 9.0 months (95% CI, 6.8 to 19.6) in patients who had received one ROS1 TKI.
• The most common treatment-related adverse events in ROS1 fusion-positive NSCLC patients treated with repotrectinib were dizziness (58%), dysgeusia (50%), and paresthesia (30%), all of which were primarily low grade. 6. 3% of patients discontinued repotrectinib due to treatment-related adverse events.
• The study included ROS1 fusion-positive NSCLC patients, with subgroups consisting of those who had not previously received a ROS1 TKI, those who had received one ROS1 TKI, and those with the ROS1 G2032R mutation; patients without prior ROS1 TKI treatment had a higher response rate (79%) and longer median duration of response (34.1 months) compared to those who had received one ROS1 TKI (38% ORR, 14.8 months DoR).