When you do your due diligence, you do not lose your faith in what you believed in giving up to the hype that’s sprayed around you. We were happy today to hear Array BioPharma (ARRY) report that results from the Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The trial met its primary endpoints.
We are happy, but not surprised, as we surely expected what was announced.
The NEMO study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine.
Binimetinib was well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.
Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and pre-specified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical meeting in 2016.
Binimetinib is also in Phase 3 COLUMBUS trial for BRAF-mutant melanoma and the Phase 3 MILO trial for low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.
To read about the trials and some other details about the drug Click HERE
Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015.
NRAS mutations occur in approximately 15% to 20% of patients with melanoma, and is a poor prognostic factor. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. Historically, a person with metastatic melanoma typically has a short life expectancy with NRAS melanoma patients living an average of 8.5 months from diagnosis.
The good news is considered great news as the presence of an NRAS mutation brings bad news — a poor prognostic indicator for patients with this type of advanced melanoma. That’s a true statement that Keith T. Flaherty, M.D., Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital has confirmed. Dr. Flaherty stated, “I am encouraged the NEMO trial met its primary endpoint and look forward to sharing the full results soon. As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition in this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy.”
Indeed, the successful results are important because the NRAS mutation is still an unmet need in spite of the advancement of the melanoma treatment in general at the hands of the new immunotherapy drugs and drug combinations. Our enthusiasm towards the benimetinib results is also caused by the fact that current clinical trial results draw optimism regarding the outcome of other trials with the same drug on other cancers that are also of poor prognosis and with no satisfying treatments.
The stock rallied Up 27.5% over yesterday’s closing price. We are expecting the same to happen with EXEL, AGEN and other small firms that were unfairly beaten by investors who might know nothing about these firms or the drugs in their pipelines. Or trying to mislead investors into selling them.
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