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Molecular Profile ROS1 fusion
Therapy Entrectinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion lung non-small cell carcinoma sensitive Entrectinib FDA approved - On Companion Diagnostic Actionable In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 77% (41/53), a median duration of response of 25 months in patients with ROS1 fusion positive non-small cell lung cancer, with median progression-free survival of 26 and 14 months for patients without (n=30) and with (n=23) CNS disease, respectively (PMID: 31838015; NCT02097810, NCT02568267). detail... 31838015
ROS1 fusion lung non-small cell carcinoma sensitive Entrectinib Phase II Actionable In a Phase II/III trial (BFAST), Rozlytrek (entrectinib) treatment demonstrated safety and efficacy in treatment-naive advanced non-small cell lung cancer patients with ROS1 fusions detected by liquid biopsy, resulting in an investigator-assessed objective response rate of 81.5% (44/54, 2 complete and 42 partial responses), clinical benefit rate of 87% (47/54), stable disease in 7 patients, median duration of response of 13 mo, and median progression-free survival of 12.9 mo (PMID: 38898120; NCT03178552). 38898120
PubMed Id Reference Title Details
Rozlytrek (entrectinib) FDA Drug Label Full reference...
(31838015) Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Full reference...
(38898120) Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial. Full reference...