At the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, Array BioPharma, Inc. (NASDAQ:ARRY) presented the full results of its Phase 3 NRAS MELANOMA AND MEK INHIBITOR (NEMO) trial of binimetinib.
Reinhard Dummer, M.D., lead study investigator, reiterated that the findings suggest that new and better treatment options might soon be available for NRAS-mutant melanoma patients.
Median PFS Enhancements
The results showed that binimetinib is capable of extending the median progression-free survival (PFS) at nearly three months. Patients who receive dacarbazine, on the other hand, only have a median PFS of 1.5 months. Dacarbazine is the first trial that met a PFS study endpoint among advanced NRAS-mutant melanoma patients.
Under the subset of patients who received prior treatment (ipilimumab, nivolumab, pembrolizumab), the median PFS was seen at 5.5 months. Those who received dacarbazine only have a median PFS of not more than two months. Dummer noted that the results in this pre-specified subset of patients is significantly promising.
Other Key Findings
Binimetinib has also illustrated improved overall response rate (ORR) and disease control rate (DCR). The ORR among binimetinib patients is 15% while the ORR among dacarbazine patients is only 7%. Patients who received binimetinib had a DCR of 58% while those who received dacarbazine had a DCR of 25%.
According to Keith Flaherty, M.D., study investigator and Termeer Center for Targeted Therapy Director at Massachusetts General Hospital, one out of five patients with advanced melanoma are affected by the NRAS-mutant melanoma. Consequently, there is a need for further treatment options.
What is binimetinib?
Binimetinib primarily inhibits MEK, a key protein in the RAS-RAF-MEK-ERK signaling pathway that regulates proliferation, angiogenesis, survival, and differentiation processes. Presently, binimetinib is being studied in several clinical trials among advanced cancer patients.
Victor Sandor, M.D., Array BioPharma Chief Medical Officer (CMO), elaborated that the latest results of the Phase 3 NEMO study strongly indicate the potentials of binimetinib in slowing the disease progression among cancer patients.
In line with these results, Sandor confirmed that Array BioPharma is looking forward to submit a regulatory filing for binimetinib later this month.