BFAST Cohort D met its primary endpoint; the confirmed ORR per investigator in this analysis was 81.5% (95% CI: 68.6–90.8) and was above the protocol-defined threshold of 70.4%, suggesting that these data are consistent with those from the historical analysis of entrectinib in patients with ROS1-positive NSCLC identified by tissue-based testing (investigator-assessed ORR: 73.4% (95% CI: 63.6–82.0), data cutoff May 2019, ≥12 months of follow-up, n = 94). Here, ROS1 is linked to non-small cell lung carcinoma.