Roche's personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents

F. Hoffmann-La Roche Ltd / Roche's personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Phase I/II study of entrectinib, an investigational medicine, showed responses in all paediatric tumour types harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) fusions, including those in the central nervous system

Data featured in the ASCO presscast on Wednesday, 15 May, and will be presented at the 2019 ASCO Annual Meeting on Sunday, 2 June

Basel, 16 May 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive data from the Phase I/II STARTRK-NG study, 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 (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.¹ 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.¹ The safety profile of entrectinib was consistent with that seen in previous analyses.¹ 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.

"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," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "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."