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Molecular Profile NTRK1 fusion
Therapy Entrectinib
Indication/Tumor Type Advanced Solid Tumor
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NTRK1 fusion Advanced Solid Tumor 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 72.7% (32/44, 20 complete (CR) and 12 partial (PR) responses) in pediatric patients (median age 4.0 yo) with solid tumors harboring NTRK fusions, with median time to response of 1.86 mo, ORR was 91.7% (22/24, 15 CR, 7 PR) in patients with extracranial solid tumors (PMID: 40086048; NCT02650401, NCT04589845, NCT02568267). 40086048
NTRK1 fusion Advanced Solid Tumor 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 57% (31/54, 4 complete response, 27 partial response) in patients with NTRK1/2/3 fusion-positive advanced solid tumors, with a median duration of response of 10 months (PMID: 31838007; 2012-000148-88, NCT02097810, NCT02568267). detail... 31838007
NTRK1 fusion Advanced Solid Tumor 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 60% (9/15) in patients harboring fusions in NTRK1/2/3 (PMID: 35395680; NCT02650401). 35395680
PubMed Id Reference Title Details
Rozlytrek (entrectinib) FDA Drug Label Full reference...
(31838007) Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Full reference...
(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...