Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications.

ABSTRACT:

Background

Entrectinib is a tropomyosin receptor kinase inhibitor approved for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours based on single-arm trials. Traditional randomised clinical trials in rare cancers are not feasible; we conducted an intrapatient analysis to evaluate the clinical benefit of entrectinib versus prior standard-of-care systemic therapies.

Methods

Patients with locally advanced/metastatic NTRK fusion-positive tumours enrolled in the global phase II, single-arm STARTRK-2 trial were grouped according to prior systemic therapy and response. The key analysis used growth modulation index [GMI; ratio of progression-free survival (PFS) on entrectinib to time to discontinuation (TTD) on the most recent prior therapy];

SUBMITTER: Krebs MG 

PROVIDER: S-EPMC8103537 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature