Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: Integrated analysis of three phase 1–2 trials
The Lancet Oncology Dec 18, 2019
Drilon A, Siena S, Dziadziuszko R, et al. - Researchers investigated the utility of entrectinib in patients with locally advanced or metastatic ROS1 fusion-positive non-small-cell lung cancer (NSCLC). Three ongoing phase 1 or 2 trials of entrectinib (ALKA-372-001, STARTRK-1, and STARTRK-2) were included in this integrated analysis. Adult patients (aged ≥ 18 years) with locally advanced or metastatic ROS1 fusion-positive NSCLC who received entrectinib at a dose of at least 600 mg orally once per day, with at least 12 months' follow-up, comprised the efficacy-evaluable population. In ALKA-372–001, enrollment of patients was done from Oct 26, 2012, to March 27, 2018; in STARTRK-1, from Aug 7, 2014, to May 10, 2018; and in STARTRK-2, from Nov 19, 2015 (enrolment is ongoing). On May 31, 2018 (the data cutoff date for this analysis), an objective response was evident in 41 (77%; 95% CI 64–88) of 53 patients in the efficacy-evaluable population. Outcomes revealed that in patients with ROS1 fusion-positive NSCLC, entrectinib is active with durable disease control, and is well tolerated with a manageable safety profile. This suggests it as amenable to long-term dosing in these patients. Data emphasize the requirement to routinely test for ROS1 fusions to broaden therapeutic options for patients with ROS1 fusion-positive NSCLC.
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