In new draft guidance, NICE recommends encorafenib plus cetuximab as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer (mCRC) in adults who have had previous systemic treatment.
The targeted combination therapy represents the first treatment licensed specifically for BRAFV600E-mutant mCRC, and is now funded for these patients on the NHS in England, Wales, and Northern Ireland.
This positive recommendation brings these patients the first licensed chemotherapy-free option.
In the phase 3 BEACON study, encorafenib plus cetuximab significantly improved median overall survival (OS) by more than half (9.3 vs 5.9 months) and reduced the risk of death by over a third (39%), compared with the control arm.
In the draft guidance, NICE acknowledged that the clinical trial evidence shows that encorafenib plus cetuximab increases OS compared with FOLFIRI plus cetuximab or irinotecan plus cetuximab.
However, NICE does not recommend cetuximab beyond first-line treatment for mCRC.
An indirect comparison of encorafenib plus cetuximab with FOLFIRI or trifluridine-tipiracil was carried out by the company using evidence from other clinical trials. However, NICE said this makes the results uncertain.
Despite this, encorafenib plus cetuximab does meet NICE’s criteria for being a life-extending treatment at the end of life. Also, despite the uncertain comparative effectiveness results, the cost-effectiveness estimates were within what NICE normally considers a cost-effective use of NHS resources.
In the UK, over 42,000 people are newly diagnosed with colorectal cancer each year, and around 23-26% have metastases at diagnosis.
The final guidance is due to be published in January 2021.
