French pharma group Pierre Fabre’s Braftovi has been recommended for NHS use by the UK’s National Institute for Health and Care Excellence (NICE) to treat BRAF-positive colorectal cancer.
Braftovi (encorafenib) combined with has been recommended Merck KGaA’s EGFR-targeting antibody Erbitux (cetuximab) has been recommended as a second-line treatment for BRAF-positive metastatic colorectal cancer (mCRC).
The positive recommendation is based on results from the phase 3 BEACON CRC study, in which Braftovi/Erbitux significantly improved overall survival (OS) by 40% compared to Erbitux and irinotecan-based chemotherapy, with a median OS of 9.3 months and 5.9 months respectively.
The trial also demonstrated that the treatment combinations was as effective as a triple therapy which also included Mektovi (binimetinib), which meant that additional toxicity from the MEK inhibitor could be avoided without comprising patient benefit.
“Securing NHS reimbursement is the culmination of collaborative discussions that we have been having with NICE and NHS England since the end of last year,” said Laura McMullin, general manager UK & Ireland, Pierre Fabre.
“In particular, we would like to recognise the efforts of NHS England who have consistently supported appropriate access for this treatment. The result underscores our commitment to the colorectal cancer community and we hope that as many people as possible will benefit from this innovative treatment,” she added.
Pierre Fabre is also looking to prove the Braftovi/Mektovi combination in earlier patient settings – the phase 2 ANCHOR CRC trial is evaluating the drug combo plus Erbitux or another EGFR inhibitor as a chemotherapy-free option for mCRC patients.
Results from this study demonstrated that the three-drug treatment produced a confirmed objective response rate (cORR) of 50%, with tumour-size reduction observed in 85% of patients. In addition, the investigator-measured median progression-free survival (PFS) rate was 4.9 months.
Over 42,000 people in the UK are newly diagnosed with colorectal cancer each year, with approximately 8-12% of patients with mCRC also carrying BRAF mutations.
“Approximately one in ten people diagnosed with advanced bowel cancer have a BRAFV600E mutation, and their treatment options are currently extremely limited,” said Genevieve Edwards, chief executive of Bowel Cancer UK.
“We worked closely with clinicians to submit evidence to the NICE consultation on the benefits of the combined therapy, and are really pleased that today’s announcement offers new hope to patients,” she added.