Roche’s Phase I/II STARTRK-NG study yields positive results

Roche’s Phase I/II STARTRK-NG study has been evaluating the investigational medicine entrectinib in children and adolescents with recurrent or refractory solid tumours with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions. The study showed entrectinib shrank tumours in all eleven children and adolescents who had NTRK, ROS1 or ALK fusion-positive solid tumours, including two patients achieving a complete response. Five patients with primary high-grade tumours in the central nervous system had an objective response, including one patient with a complete response. The safety profile of entrectinib was consistent with that seen in previous analyses.
Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “We are encouraged by the results we have seen with entrectinib in children with paediatric and adolescent cancers, including those with tumours in the brain. 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.”