07-05-2016

Pierre Fabre, Array BioPharma and Merck Announce the launch of the first Phase 3 BEACON CRC Trial in BRAF-mutant colorectal cancer

Pierre Fabre, Array BioPharma (Nasdaq: ARRY) and Merck (MRCG / MRK GY / MRK.DE) announced the initiation of the BEACON CRC (Binimetinib, Encorafenib And Cetuximab Combined to treat BRAF-mutant Colorectal Cancer) trial, a randomized, global Phase 3 clinical trial designed to assess the safety and efficacy of binimetinib (MEK inhibitor), encorafenib (BRAF inhibitor) and Erbitux (monoclonal antibody) in comparison to Erbitux and irinotecan-based therapy in patients with BRAF-mutant colorectal cancer (BRAFm CRC). The primary endpoint is overall survival (OS) and key secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).

We are pleased to announce the initiation of the BEACON trial with our US and German partners Array BioPharma and Merck,This is the first time that a triple combination of targeted therapies: BRAF inhibitor, MEK inhibitor and EGFR inhibitor is evaluated in a large, international phase 3 trial for patients with BRAF-mutant colorectal cancer, said Eric Chetaille Head of Oncology R&D Unit within Pierre Fabre Pharmaceuticals R&D team. This trial offers new hope for improving outcomes in a population of patients with a particularly poor prognosis and a high unmet medical need.

Trial Design 

BEACON CRC is a randomized, open-label, global study evaluating the efficacy and safety of binimetinib, encorafenib and Erbitux in patients with BRAFm metastatic CRC who have previously received first-line systemic therapy.  Approximately 615 patients are expected to be randomized 1:1:1 to receive triplet therapy (binimetinib, encorafenib and Erbitux), doublet therapy (encorafenib and Erbitux) or the control arm (irinotecan-based therapy and Erbitux). 

The primary endpoint of the trial is overall survival (OS) of the triplet therapy compared to the control arm. The secondary endpoints address efficacy of the doublet therapy compared to the control arm, and the triplet therapy compared to the doublet therapy. Other key secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response, safety and tolerability. Health related quality of life data will also be assessed. 

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 Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d’Hebron University Hospital and elected ESMO President 2018-2019. 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.

The trial will be conducted at over 250 investigational sites in North America, South America, Europe and the Asia Pacific region. Patient enrollment is expected to be completed in 2018.

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