Pierre Fabre’s triplet therapy makes strong showing in BRAF V600E-mutant metastatic colorectal cancer
Pierre Fabre chose the European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain, to unveil new Phase 3 data on its encorafenib triplet therapy in the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC), in patients who have already received one or two lines of therapy.
“BEACON is a Phase 3 global trial investigating the combination of three targeted therapies to treat BRAF V600E-mutant metastatic colorectal cancer. It is the first Phase 3 study designed specifically to test a BRAF/MEK inhibitor in combination with cetuximab in patients with advanced colorectal cancer who have a mutation in the BRAF V600E gene in their cancer,” said Dr Harpreet Wasan, Consultant Oncologist, London and BEACON Chief Investigator in the UK. “By combining three targeted therapies, without conventional cytotoxic chemotherapy, we have shown significantly improved survival outcomes not seen before in this patient population.”
The triplet contains the BRAF inhibitor encorafenib, the MEK inhibitor binimetinib, and the anti-EGFR antibody cetuximab. The data revealed that the combo “demonstrated a statistically significant improvement in median overall survival(OS)”, extending it by nine months compared to 4.3 months in the control group treated with cetuximab plus irinotecan-containing regimens. The triplet also registered an improved overall response (OS) rate of 26% compared to 2% for the encorafenib triplet and control group respectively, while median progression-free survival (PFS) stood at 4.3 months versus 1.5 months.
Additionally, interim analysis showed that the combination of encorafenib and cetuximab, known as the encorafenib doublet, improved median OS by 8.4 months with an objective response rate (ORR) of 20% compared to 5.4 months and 2% in the control group.
“The BEACON trial is the first and only Phase 3 study specifically investigating patients with BRAFV600E-mutant metastatic colorectal cancer to have reached its primary endpoint,” commented Laura McMullin, General Manager UK & Ireland at Pierre Fabre. “Today’s results demonstrate the potential of combining targeted therapies and we are thrilled with the survival outcomes and generally manageable adverse event profile. While the data are from an investigational study only at the moment, they will now be used in our licensing discussions with regulatory bodies so that we can potentially bring this innovative combination to patients as soon as possible.”
Both the doublet and triplet were “generally well-tolerated with no unexpected toxicities” and their safety profiles were found to be consistent with previous studies, though severe Grade 3 adverse events occurred in 58% of patients with the encorafenib triplet, 50% with the doublet, and 61% in the control group.
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