Array BioPharma Inc. recently presented the latest results of its Phase 2 clinical trial of binimetinib in patients with advanced NRAS mutant melanoma, at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain.
Binimetinib, which is licensed to Novartis, is a small-molecule MEK inhibitor, an essential protein kinase in the RAS/RAF/MEK/ERK pathway, essential for multiple aspects of cancer progression that specifically targets a key enzyme in this pathway.
There are 15 to 25% of melanoma patients who carry NRAS mutations, transforming it into a more severe form of skin cancer with an associated median overall survival of only 8.2 months.
This clinical study, which was in agreement with previous results presented at the American Society of Clinical Oncology 2012 annual meeting, enrolled 117 patients and showed median progression free survival of 3.6 months, median overall survival of 12.2 months, and an objective response rate of 14.5%. Additionally, one of the patients was able to achieve a complete response, which is a very promising result, considering that this population of melanoma patients is associated with very poor prognosis.
There are currently three Phase 3 clinical trials assessing the efficacy and safety of binimetinib in advanced cancer patients — low-grade serous ovarian cancer (MILO), BRAF-mutant melanoma (COLUMBUS) and NRAS-mutant melanoma (NEMO), which has been specifically designed to evaluate the difference in progression-free survival between patients treated with binimetinib versus those treated with dacarbazine, a chemotherapy drug commonly used to treat malignant melanoma.
So far, NRAS-mutant melanoma is the only potential indication for binimetinib, with a projected regulatory filing estimated in 2015.
“Patients with NRAS mutations have no targeted treatment available and prognosis is poor. These data reinforce our view that binimetinib is an important new potential treatment option for these patients and I look forward to seeing the results from the ongoing Phase 3 NEMO trial to validate these findings,” Reinhard Dummer, M.D., University of Zurich Hospital, Zurich, Switzerland said in an Array BioPharma press release.