Results Of Nemo: A Phase Iii Trial Of Binimetinib (Bini) Vs Dacarbazine (Dtic) In Nras-Mutant Cutaneous Melanoma.

9500Background: NRAS mutation in melanoma occurs in ~20% of patients (pts). There are no specific therapies for NRAS melanoma. Despite emergence of immunotherapies (ITs) as effective treatments in melanoma, there is a high unmet need in these pts, particularly after failure of IT. Methods: In this open-label phase III study (ClinicalTrials.gov, NCT01763164), pts with advanced unresectable/metastatic cutaneous NRAS-mutant melanoma who were previously untreated or had progressed on/after prior IT were randomized 2:1 to BINI 45 mg PO BID or DTIC 1000 mg/m2 IV every 3 wk. Pts were stratified by stage, ECOG PS and prior IT for unresectable/metastatic disease. Progression-free survival (PFS) per independent central review was the primary endpoint. Overall survival (OS) was the key secondary endpoint; other secondary endpoints included confirmed overall response rate (ORR) and disease control rate (DCR). Results: 402 pts were randomized to BINI (n = 269) or DTIC (n = 133). The planned primary PFS analysis and pr...