Array BioPharma achieved a $5 million milestone after the start of its Phase III clinical trial in patients with low-grade serous ovarian cancer (LGSOC).
The study, called MILO (MEK Inhibitor in Low-Grade Serous Ovarian Cancer), is a multinational, randomized Phase III trial that aims to evaluate MEK162 against physician’s choice of standard chemotherapy treatments in 300 patients with recurrent or persistent LGSOC following at least one prior platinum-based chemotherapy regimen and no more than three lines of prior chemotherapy regimens. The primary endpoint is progression-free survival, and the key secondary endpoint is overall survival.
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, and MEK162 is a small molecule MEK inhibitor that, according to Array, targets a key position in this pathway. Array invented MEK162 (formerly known as ARRY-162) and licensed worldwide rights to develop and commercialize the drug to Novartis in April of 2010. Under terms of that agreement, Array received an up-front and milestone payment of $45 million and was eligible to receive an additional $422 million if certain clinical, regulatory, and commercial milestones are achieved. Array achieved another milestone under this agreement back in April of 2011, receiving $10 million.
Novartis recently detailed plans to initiate Phase III trials of MEK162 in both NRAS- and BRAF-mutant melanoma. All three trials will be conducted as part of the Novartis/Array co-development agreement.