Pierre Fabre, Merck KGaA and Array BioPharma ($ARRY) have teamed up to trial a triple combination therapy in a hard-to-treat subpopulation of colorectal cancer patients. The Phase III trial will test the BRAF and MEK inhibitors Pierre Fabre licensed from Array last year in combination with Merck KGaA’s Erbitux.
By combining binimetinib and encorafenib, the aforementioned late-phase MEK and BRAF inhibitors, with Merck KGaA’s established colorectal cancer drug Erbitux, Array and its partner Pierre Fabre think they have a shot at treating patients with BRAF-mutant forms of the disease. The trial will randomize 615 patients to receive either the binimetinib-encorafenib-Erbitux triple combination, just the latter two drugs or a control mix of Merck KGaA’s drug and irinotecan-based therapy.
The primary endpoint is the overall survival associated with the triple therapy in comparison to the control arm. Investigators will also compare the triple combination to the encorafenib-Erbitux mix, and the latter to the control arm, as part of a suite of secondary efficacy measures. Progression-free survival, objective response rate, duration of response, safety and quality-of-life measures will be assessed by the secondary endpoints.
Castres, France-based Pierre Fabre will cover 40% of the cost of the clinical trial, the same share of R&D spend it committed to when it licensed the European rights to binimetinib and encorafenib from Array in a $455 million (€400 million) deal last year. The outcome of the trial will go some way to determining the success, or otherwise, of the deal, as well as what proportion it will pay of the $425 million in milestones attached to the agreement.
The Array deal was the headline event in a busy year for Pierre Fabre’s cancer business development team, which entered into 7 agreements in 2015. This flurry of activity followed a decision late in 2014 to lay off 272 researchers and focus R&D activities on oncology, neuroscience and dermatology, actions that upped the importance of both cancer and external alliances to the company.
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