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news.Array BioPharma, Pierre Fabre and Merck have started a phase 3 trial to evaluate safety and efficacy of binimetinib, encorafenib and Erbitux (cetuximab) in BRAF-mutant colorectal cancer.
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The primary endpoint of the Beacon CRC trial is overall survival (OS), whiles secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).
The companies will carry out the trial at more than 250 investigational sites in North America, South America, Europe and the Asia Pacific region. Patient enrollment is planned to be completed in 2018.
About 615 patients are anticipated to be randomized 1:1:1 to receive triplet therapy (binimetinib, encorafenib and Erbitux), doublet therapy (encorafenib and Erbitux) or the scontrol arm (irinotecan-based therapy and Erbitux).
Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor.
Erbitux is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).
It has already secured market authorization in more than 90 countries globally to treats colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN).
Array BioPharma chief medical officer of Victor Sandor said: "We believe the encouraging results shown in our Phase 2 study suggest that concurrent inhibition of EGFR and MAPK signaling pathways has the potential to improve outcomes for this high unmet need patient population."