Phase 3 Binimetinib Trial in Ovarian Cancer Discontinued Due to Futility
The MILO study, a phase 3 trial of binimetinib for the treatment of patients with low-grade serous ovarian cancer, has been stopped.
The MILO study, a phase 3 trial of binimetinib for the treatment of patients with low-grade serous ovarian cancer, has been stopped, according to a press release issued by Array BioPharma.1
The decision was made after results from a planned interim analysis showed that the hazard ratio for progression-free survival crossed the predefined futility boundary. Final results from the study were expected in 2017.
Victor Sandor, MD, 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.”
MILO is an international, randomized phase 3 trial of binimetinib or physician's choice of chemotherapy (ie, liposomal doxorubicin, paclitaxel, or topotecan) in patients with recurrent or persistent low-grade serous ovarian cancer. Its primary endpoint was progression-free survival and secondary endpoints were overall survival, overall response rate, duration of response, disease control rate, safety, and quality of life.
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Binimetinib is a small-molecule MEK inhibitor that targets key enzymes in this pathway, which has shown to regulate several key cellular activities such as proliferation, differentiation, migration, survival, and angiogenesis.
- Array BioPharma announces decision to discontinue MILO study in ovarian cancer [news release]. Boulder, CO: Array BioPharma; April 1, 2016. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=2152468. Accessed April 4, 2015.