Merck Partners with Array BioPharma and Pierre Fabre to Initiate BRAF-mutant CRC Phase III Trial

DARMSTADT, Germany, June 4, 2016 /PRNewswire/ --

Not intended for UK- or US-based media 

• BEACON CRC trial will assess efficacy of combination regime Erbitux^® (cetuximab), binimetinib and encorafenib in BRAF-mutant metastatic colorectal cancer (mCRC) 

Merck, a leading science and technology company, jointly announced with Array BioPharma Inc. and Pierre Fabre, the initiation of a prospective, randomized, 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 tumors, compared with investigator's choice of Erbitux plus irinotecan or Erbitux plus FOLFIRI.

     (Logo: http://photos.prnewswire.com/prnh/20151207/293543LOGO )

     (Logo: http://photos.prnewswire.com/prnh/20151019/278051LOGO )

"This trial looking specifically at BRAF-mutated tumors 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 percent 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 6 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."