Array BioPharma Announces Decision To Discontinue MILO Study In Ovarian Cancer
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.
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.
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future development plans of binimetinib and the timing of the announcement of further results of clinical trials for binimetinib; expectations that events will occur that will result in greater value for Array; and the potential for the results of current and further clinical trials to support regulatory approval or the marketing success of binimetinib. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/array-biopharma-announces-decision-to-discontinue-milo-study-in-ovarian-cancer-300244593.html