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Array Announces Global Phase 3 Trial Evaluating MEK162 In Patients With Low-Grade Serous Ovarian Cancer
Date:5/6/2013

.  The historic median progression free survival for LGSOC patients treated with chemotherapy is approximately seven months. 

About MEK Inhibition and Low-grade Serous Ovarian Cancer
At AACR 2012, results for selumetinib, a small-molecule MEK inhibitor invented by Array and licensed to AstraZeneca, were presented from a Gynecologic Oncology Group Phase 2 clinical trial in patients with recurrent LGSOC.  In the study, 52 patients received 50-mg of selumetinib orally twice daily in four-week cycles until disease progression or toxicity.  Fifty-eight percent of patients had received three or more rounds of chemotherapy.  The median number of cycles was 4.5; 33 percent of patients underwent 12 or more cycles.  The disease control rate was 81 percent.  Eight patients (15 percent) had complete (1) or partial (7) responses, and 34 patients (65 percent) had progression-free survival of greater than six months.  The median progression free survival was 11 months.  The drug was generally well tolerated.  There were three grade 4 adverse events of cardiac, pain and pulmonary reported.  The most common grade 3 adverse events were gastrointestinal (25%) and dermatological (17%).

About MEK162
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which signals cancer cell proliferation and survival. MEK has been shown to be activated in several tumor types such as non-small cell lung cancer, melanoma, thyroid cancer, ovarian cancer, and, in particular, tumors with BRAF and NRAS mutations.  MEK162 is a small molecule MEK inhibitor that targets a key position in this pathway and is in Phase 2 development in a range of tumor types.   

There are 10 active or completed oncology clinical trials of MEK162 with plans to initiate at least six trials in 2013, including three Phase 3 trials, one each planned in LGSOC, NRAS-mutant melanoma and BRAF-mutant melanoma.

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SOURCE Array BioPharma
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