Pierre Fabre receives European Commission Marketing Authorisation for BRAFTOVI® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy

Reading, United Kingdom (June 2020) – Pierre Fabre today announced that the European Commission (EC) has granted Marketing Authorisation for BRAFTOVI^®q (encorafenib) in combination with Erbitux^® (cetuximab) for the treatment of adult patients with BRAF^V600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy. The EC’s review applies to all 27 EU member states plus Iceland, Liechtenstein, Norway and the UK. Currently, there are no other licensed targeted regimens in Europe indicated for this specific patient population, meaning up until now there has been an urgent treatment need.  

“This Marketing Authorisation represents a major milestone for metastatic colorectal cancer patients, with a BRAF^V600E mutation, since we are now able to combine two specific, targeted therapies without the need for any conventional, cytotoxic chemotherapy,” said Dr Harpreet Wasan, Consultant Oncologist, London and BEACON Chief Investigator in the UK. “Conventional, cytotoxic chemotherapy is associated with suppression of the immune system and so this chemotherapy-free option is particularly relevant in the current COVID-19 climate; potentially also avoiding the use of permanent indwelling venous catheters, with the aim of reducing patient visits to hospitals. Currently in the UK, there are no available treatments specifically targeting BRAF^V600E metastatic colorectal cancer. These patients generally have worse outcomes and a poor prognosis, when treated with standard chemotherapy. Today’s licensing offers a significantly better option in their disease management.”

“The licencing of encorafenib and cetuximab has the potential to make a difference to the lives of metastatic colorectal patients who have a BRAF^V600E mutation,” said Sarah Stimpson, who trained originally as a nurse and is now a senior clinical research practitioner in the lead UK centre for the BEACON study. “In the UK, intravenous cytotoxic chemotherapy is the standard treatment for these patients and it is often associated with many side effects. In the pivotal BEACON study, this targeted therapy with a partly oral combination offers improved survival and is generally well-tolerated. Our hope now is that the significant benefits of this combination will be recognised by the UK for routine NHS availability; providing access to all our colorectal cancer patients, who show the BRAF^V600E mutation.”

The EC’s Marketing Authorisation is based on data from the pivotal Phase 3 BEACON CRC trial, the first and only Phase III Study, specifically investigating patients with BRAF^V600E-mutant mCRC to have met its primary endpoint. The data showed that encorafenib in combination with cetuximab significantly improved median overall survival (OS) in patients with BRAF^V600E-mutant mCRC (9.3 months vs 5.9 months; hazard ratio: 0.61; 95% confidence interval: 0.48–0.77; p<0.0001) and reduced the risk of death by 39%, compared to the cetuximab plus irinotecan-containing regimen (control) arm. Furthermore, the combination reported an improved objective response rate (ORR) (20% vs 2%; p<0.0001, per assessment by blinded independent central review [BICR]), compared to the control arm.

Encorafenib plus cetuximab demonstrated a generally well-tolerated side effect profile. The most common adverse drug reactions (>25%) observed in the BEACON CRC trial for encorafenib in combination with cetuximab were fatigue, nausea, diarrhoea, dermatitis acneiform, abdominal pain, arthralgia/musculoskeletal pain, decreased appetite, rash and vomiting. The rate of all study drug discontinuation due to any adverse reaction was 1.9% in patients treated with encorafenib plus cetuximab.

“This is a really promising step forwards for the one in ten people diagnosed with bowel cancer who have a BRAF^V600E mutation, whose treatment options are limited,” said Genevieve Edwards, Chief Executive of Bowel Cancer UK. “We’d like to see decisions made quickly by the relevant bodies in the UK to make this available on the NHS for everyone who could benefit as soon as possible.”

Pierre Fabre has entered discussions with the National Institute for Health and Care Excellence (NICE) in England, the All Wales Medicines Strategy Group (AWMSG) in Wales and the Scottish Medicines Consortium (SMC) in Scotland to discuss the possibility of making encorafenib plus cetuximab available on the NHS.

“We are delighted with today’s granting of Marketing Authorisation, which potentially brings UK patients living with BRAF^V600E-mutant metastatic colorectal cancer a step closer to an innovative new treatment option,” said Laura McMullin, General Manager UK & Ireland, Pierre Fabre. “Looking forward, we will now work in close collaboration with health authorities throughout the UK with a view to securing NHS access to encorafenib plus cetuximab for this high medical need population as soon as possible.”