Written by Prof Tim Maughan, Principal Investigator of the FOCUS4 project
Last weekend (Saturday 18 September 2021) a key outcome from the FOCUS4 trial was presented at oral session in the European Society of Medical Oncology (ESMO) annual meeting. In parallel two papers have been published in the Journal of Clinical Oncology. So what is FOCUS4 and why has it been considered a flagship precision medicine cancer trial?
FOCUS4 opened back in 2014, following approval of funding from both EME/ NIHR and Cancer Research UK. It is a randomised trial investigating treatments for metastatic colorectal cancer using a complex adaptive methodology which is known as Multi-Arm, Multi-Stage (MAMS) design. Such trials, also called umbrella or platform trials, allow for multiple treatments to be tested simultaneously against the standard of care (the control). However, FOCUS4 has the added complexity of stratified medicine, which requires that all eligible patients undergo genome sequencing to identify genetic biomarkers relating to their cancer. Patients are then matched to the trial arm/treatment to which they are most likely to respond.