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Molecular Profile ROS1 fusion
Therapy Entrectinib
Indication/Tumor Type Advanced Solid Tumor
Response Type predicted - sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 fusion Advanced Solid Tumor predicted - sensitive Entrectinib Case Reports/Case Series Actionable In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival no reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 62.5% (5/8) in patients harboring ROS1 fusions (PMID: 35395680; NCT02650401). 35395680
ROS1 fusion Advanced Solid Tumor predicted - sensitive Entrectinib Clinical Study - Cohort Actionable In a combined analysis of 3 clinical trials (STARTRK-NG, TAPISTRY, STARTRK-2), Rozlytrek (entrectinib) treatment resulted in an objective response rate (ORR) of 65.0% (13/20, 3 complete (CR) and 10 partial (PR) responses) in pediatric patients (median age 7.5 yo) with solid tumors harboring ROS1 fusions, with median time to response of 1.87 mo, ORR was 58.3% (7/12, 1 CR, 6 PR) in patients with extracranial solid tumors (PMID: 40086048; NCT02650401, NCT04589845, NCT02568267). 40086048
PubMed Id Reference Title Details
(35395680) Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG). Full reference...
(40086048) Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Full reference...