Phase III BEACON trial of Erbitux (cetuximab) + encorafenib with or without binimetinib for colorectal cancer- Merck KGaA, Array BioPharma and Pierre Fabre

Merck KGaA, jointly announced with Array BioPharma Inc. (Boulder, Colorado, U.S.A) and Pierre Fabre (Paris, France), 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.

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 randomized 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.