Roche study showed entrectinib shrank tumours (objective response rate; ORR) in all children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumours (11 of 11 patients), including two patients achieving a complete response.
This study was the Phase I/II STARTRK-NG, testing the investigational medicine entrectinib in young patients with recurrent or refractory solid tumours with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.
The Swiss-based company said that, of the 11 patients, five patients with primary high-grade tumours in the central nervous system (CNS) had an objective response, including one patient with a complete response. The safety profile of entrectinib was consistent with that seen in previous analyses.
Data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Sunday, 2 June, 2019, from 8:00 – 8:12 am CDT (Abstract 10009), and was part of yesterday’s official ASCO presscast, Roche said.
Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development said the results shown with entrectinib in children with paediatric and adolescent cancers, including those with tumours in the brain are encouraging.
“The STARTRK-NG study underscores the importance of combining comprehensive genomic profiling with targeted therapies and supports our approach to providing people with personalised medicines developed specifically for their type of cancer.”
The FDA recently granted Priority Review for entrectinib for both the treatment of paediatric and adult patients with NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic ROS1-positive NSCLC.