On April 1, 2016 Array BioPharma Inc. (Nasdaq: ARRY) reported its decision to discontinue the MILO study, a Phase 3 trial of binimetinib for the treatment of patients with low-grade serous ovarian cancer (Press release, Array BioPharma, APR 1, 2016, View Source [SID:1234510287]). The decision to stop the study was made after a planned interim analysis showed that the Hazard Ratio for Progression Free Survival (PFS) crossed the predefined futility boundary. Top-line results from the study had been expected in 2017. Schedule your 30 min Free 1stOncology Demo! Array will work with investigators to appropriately conclude the MILO study in a manner consistent with the best interest of each patient, while more detailed results will be shared with the scientific community in the future. All other ongoing studies of binimetinib, including the Phase 3 COLUMBUS (BRAF-mutant melanoma) and NEMO (NRAS-mutant melanoma) trials, are unaffected.
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Victor Sandor, M.D., Chief Medical Officer of Array, said: "While we are disappointed by this outcome, the findings from MILO have no impact on the other studies of binimetinib, including the NEMO trial, which has already met its primary endpoint, and the COLUMBUS trial, which is designed to test a highly precedented combination of mechanisms in patients with BRAF-mutant melanoma."
About MILO
The MILO trial, (NCT01849874), is an international, randomized Phase 3 study of binimetinib or a chemotherapy chosen by a physician (liposomal doxorubicin, paclitaxel or topotecan) in patients with recurrent or persistent low-grade serous ovarian cancer. The primary endpoint of the study is PFS and secondary endpoints include overall survival, overall response rate, duration of response, disease control rate, safety and quality of life.
About Binimetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including non-small cell lung cancer, melanoma, and colorectal cancer. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in this pathway. Binimetinib is in late-stage development, with a primary Phase 3 program (COLUMBUS) in BRAF-mutant melanoma in combination with BRAF inhibitor, encorafenib. Binimetinib is also being investigated in a Phase 3 study (NEMO) in patients with NRAS-mutant melanoma.