Roche reports positive Phase I/II data for entrectinib

17th May 2019 (Last Updated May 17th, 2019 00:00)

Roche has reported that its investigational personalised medicine entrectinib shrank tumours in the Phase I/II STARTRK-NG clinical trial involving children and adolescents with recurrent or refractory solid tumours.

Roche reports positive Phase I/II data for entrectinib
IBI188 is a fully human monoclonal antibody designed to target the CD47 antigen on tumour cells. Credit: Penn State/Flickr.

Roche has reported that its investigational personalised medicine entrectinib shrank tumours in the Phase I/II STARTRK-NG clinical trial involving children and adolescents with recurrent or refractory solid tumours.

The trial enrolled patients with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.

All 11 subjects with NTRK, ROS1 or ALK fusion-positive solid tumours experienced shrinkage in tumours and two of them achieved a complete response.

Of the 11 patients, five suffering from primary high-grade tumours in the central nervous system (CNS) experienced an objective response and one patient achieved a complete response.

The safety profile of the study drug was also found to be consistent with that observed in prior analyses.

Roche chief medical officer and global product development head Sandra Horning 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.”

Entrectinib is a selective tyrosine kinase inhibitor intended to inhibit the TRK A/B/C and ROS1 proteins’ kinase activity. Activating fusions of these proteins are known to cause proliferation in some cancer types.

"We are encouraged by the results we have seen with entrectinib in children with paediatric cancers."

The medicine can block ROS1 and NTRK kinase activity, leading to the death of cancer cells harbouring these gene fusions.

The open-label, dose-escalation and expansion STARTRK-NG trial assessed the safety and efficacy of entrectinib in children and adolescent patients lacking curative first-line treatment.

Results from the study will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, on 2 June.