Policy & Regulation
Array BioPharma and Pierre Fabre Pharmaceuticals Provide Results from Phase 3 Trial of Encorafenib and Binimetinib Combination Treatment in Patients with BRAF-Mutant Melanoma
12 February 2018 - - Boulder, Colorado-based cancer treatment developer Array BioPharma (NASDAQ: ARRY) and Castres, France-based pharmaceutical and cosmetics company Pierre Fabre Pharmaceuticals have released results of the planned analysis of overall survival from the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma, the companies said.
Treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily.
Median OS was 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.
At the time of the planned analysis comparing COMBO450 to vemurafenib monotherapy, a preliminary analysis of OS in patients treated with 300 mg encorafenib alone daily (ENCO300), demonstrated a median OS of 23.5 months.
The COLUMBUS trial is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation.
Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Prior immunotherapy treatment was allowed.
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK).
Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer.
Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.
Array BioPharma is focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.
Eight registration studies are currently advancing related to seven Array-owned or partnered drugs: binimetinib (MEK162), encorafenib (LGX818), selumetinib (partnered with AstraZeneca), danoprevir (partnered with Roche), ipatasertib (partnered with Genentech), larotrectinib (partnered with Loxo Oncology) and tucatinib (partnered with Cascadian Therapeutics).
Pierre Fabre has a wide-ranging portfolio of complementary products, from prescribed drugs to dermo-cosmetics, also incorporating OTC drugs, and natural health.
The company's products and innovative solutions address the full spectrum of health care needs from high-prevailing pathologies (such as cancer or atopical dermatitis) to rare diseases (such as pediatric hemangioma), from day-to-day illnesses and family hygiene to skin, hair and scalp care.