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Journal Article

PMID

(40086048)

Authors

Desai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, André N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E

Title

Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions.

Journal	Vol	Issue	Date	Pages	Journal Short Title
European journal of cancer (Oxford, England : 1990)	220		2025 Feb 22	115308	Eur J Cancer

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Abstract Text

Entrectinib, a central nervous system (CNS)-penetrant TRK/ROS1 inhibitor, has demonstrated clinical activity in children with NTRK1/2/3 or ROS1 fusion-positive extracranial solid and CNS tumours. We present integrated data of entrectinib in children with NTRK or ROS1 fusion-positive tumours from the STARTRK-NG, TAPISTRY, and STARTRK-2 trials.Efficacy analyses were undertaken on TRK/ROS1 inhibitor-naïve patients aged <18 years with metastatic/locally advanced NTRK1/2/3 or ROS1 fusion-positive extracranial solid or CNS tumours who received ≥1 entrectinib dose and had ≥6 months of follow-up from enrolment. Tumour responses were confirmed by blinded independent central review (BICR) per RECIST v1.1/RANO criteria.BICR-assessed confirmed objective response rate (cORR). Key secondary endpoints: duration of response (DoR); time to response (TtR); safety.As of 16 July 2023, out of 91 safety-evaluable patients, 64 (NTRK: n=44; ROS1: n=20) were efficacy evaluable. In the NTRK and ROS1 subgroups, respectively, median age was 4.0 years and 7.5 years; median survival follow-up was 24.2 months and 27.6 months. cORR was 72.7 % (NTRK, 95 % confidence interval [CI]: 57.2-85.0) and 65.0 % (ROS1, 95 % CI: 40.8-84.6). Median DoR was not reached (NTRK, 95 % CI: 25.4-not evaluable [NE]); ROS1, 95 % CI: 16.2-NE); median TtR was 1.9 months in both subgroups. The most frequently reported treatment-related adverse events included weight gain (35.2 %) and anaemia (31.9 %).Integrated data from three trials confirm entrectinib induces rapid and durable responses in children with NTRK or ROS1 fusion-positive tumours. The increased duration of safety monitoring does not demonstrate new or cumulative toxicity. Registered clinical trials: STARTRK-NG: NCT02650401; TAPISTRY: NCT04589845; STARTRK-2: NCT02568267.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ROS1 fusion	central nervous system cancer	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 75.0% (6/8, 2 CR, 4 PR) in patients with CNS tumors (PMID: 40086048; NCT02650401, NCT04589845, NCT02568267).	40086048
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

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