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Melanoma Drug Binimetinib Succeeds in Late-Stage Study

Regulatory submission expected in first half of 2016

Positive results have been reported from an ongoing phase III trial of the MEK inhibitor binimetinib in patients with advanced NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine. The median PFS in the binimetinib arm was 2.8 months compared with 1.5 months in the dacarbazine arm (hazard ratio, 0.62; P < 0.001).

The drug’s developer (Array BioPharma) plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. 

The ongoing international, randomized NEMO trial involves 402 patients with advanced NRAS-mutant melanoma who received continuous binimetinib (45 mg twice daily) or dacarbazine (1,000 mg/m2) every 3 weeks. Prior immunotherapy treatment was allowed. Patients undergo radiographic assessment of disease status every 6 weeks. More than 100 sites in North America, Europe, South America, Asia, and Australia are participating in the study.

MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway. Research has shown that this pathway regulates several key cellular activities, including proliferation, differentiation, migration, survival, and angiogenesis. Inappropriate activation of proteins in this pathway occurs in many cancers, including non–small-cell lung cancer, melanoma, and colorectal, ovarian, and thyroid cancers. Binimetinib is a small-molecule MEK inhibitor that targets key enzymes in this pathway. Binimetinib is being studied in three ongoing phase III trials in patients with advanced cancer: NRAS-mutant melanoma (NEMO), low-grade serous ovarian cancer (MILO), and BRAF-mutant melanoma (COLUMBUS).

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the U.S., with approximately 74,000 new cases and nearly 10,000 deaths from the disease expected to occur in 2015. NRAS mutations are found in approximately 15% to 20% of patients with melanoma and are known to be a poor prognostic factor. When melanoma is diagnosed early, it is generally a curable disease. However, when it metastasizes, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has a short life expectancy, with NRAS melanoma patients living an average of 8.5 months after diagnosis.

Source: Array BioPharma; December 16, 2015

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