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Merck, a leading science and technology company, jointly announced with Array BioPharma Inc. and Pierre Fabre, the initiation of a prospective, randomised, global Phase III clinical trial of BRAF-mutant metastatic colorectal cancer (mCRC), investigating a new combination of Erbitux® (cetuximab), a standard-of-care treatment for RAS wild-type mCRC, plus encorafenib with or without binimetinib. The BEACON CRC (Binimetinib, Encorafenib And Cetuximab Combined to treat BRAF-mutant Colorectal Cancer) trial will assess the efficacy and safety of these two novel combinations in patients with BRAF-mutant tumours, compared with investigator’s choice of Erbitux plus irinotecan or Erbitux plus FOLFIRI.
“This trial looking specifically at BRAF-mutated tumours exemplifies our ongoing commitment to exploring Erbitux as an ‘anchor’ treatment in combination with other therapies,” said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. “There is a clear need for effective treatment regimens for the BRAF-mutant mCRC population; the results of the BEACON CRC trial will hopefully provide us with the prospective information we need to take us one step closer to achieving that goal.”
Colorectal cancer (CRC) is one of the most challenging types of cancers, with an estimated 10% of CRCs associated with an oncogenic mutation in the BRAF gene.1 Studies have observed that patients with BRAF-mutant mCRC have shorter progression-free survival and overall survival.2 Additional treatment regimens are needed that can effectively combat these cancers.
“Historical studies suggest that BRAF-mutant colorectal cancer patients who have progressed after first-line systemic treatment have an estimated median overall survival of less than six months,” said Dr Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d’Hebron University Hospital. “The BEACON CRC trial will explore innovative combinations which have the potential to offer new treatment options to these patients, who currently have few good choices remaining.”
“We are pleased to join Merck on this innovative trial for patients with BRAF-mutant metastatic colorectal cancer,” said Victor Sandor, MD, Chief Medical Officer of Array BioPharma. “The encouraging results from our Phase II study suggest that concurrent inhibition of EGFR and enzymes in the MAPK signalling pathway has the potential to improve outcomes for this patient population, and we look forward to the results of this further investigation.”
Approximately 650 patients are expected to be enrolled by 2018 and, after a lead-in period to assess the safety and tolerability of Erbitux plus encorafenib (BRAF inhibitor) and binimetinib (MEK inhibitor), will be randomised to receive one of the two novel combinations, or investigator’s choice. The primary endpoint of the trial is overall survival. Key secondary endpoints include progression-free survival, objective response rate, duration of response, safety and tolerability. The trial will also assess health-related quality of life.