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Updated: Jan 15, 2026
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Real-World Efficacy and Safety of MEK Inhibitor for Patients With Advanced NRAS-Mutant Melanoma: A Single-Center
Eiji Nakano1, Yuta Kage1, Dai Ogata1
1Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Abstract:
NRAS mutations represent the second most common genetic alteration in melanoma and are associated with aggressive disease and limited treatment options. While MEK inhibitors have shown clinical benefit in patients with NRAS-mutant melanoma in clinical trials, real-world data in Asian populations remain limited. We conducted a retrospective analysis of patients with advanced NRAS-mutant melanoma treated with binimetinib at the National Cancer Center Hospital. NRAS mutations were confirmed via comprehensive genomic profiling. Fifteen patients were included, with a median age of 66 years. Most had mucosal melanoma (80.0%), and NRAS mutations at codons 12, 13, and 61 were seen in seven, one, and seven patients, respectively. One patient (6.7%) achieved a partial response, and eight (53.3%) had stable disease, resulting in a disease control rate of 60.0%. The median PFS was 3.1 months (95% confidence intervals, 1.5-4.6), and the median OS was 4.8 months (95% confidence intervals, 1.8-8.8). Fourteen patients (93.3%) experienced at least one adverse event (AE), with skin rash being the most common. Grade ≥ 3 AEs occurred in 4 patients (26.7%), and 8 (53.5%) required dose interruption. Binimetinib demonstrated modest clinical activity and manageable safety in Japanese patients with advanced NRAS-mutant melanoma, with outcomes comparable to those observed in Western populations. This study is limited by its retrospective design and small sample size, warranting cautious interpretation of results. These findings provide supportive evidence for the use of binimetinib in patients with NRAS-mutant melanoma following immune checkpoint inhibitor failure.
Insights
Binimetinib showed modest effectiveness and manageable safety in Japanese patients with advanced NRAS-mutant melanoma. Real-world data suggest comparable outcomes to Western populations, supporting its use after other treatments fail.
Area of Science:
- Oncology
- Dermatology
- Genetics
Background:
- NRAS mutations are common in melanoma, linked to poor prognosis and few treatment options.
- MEK inhibitors show promise for NRAS-mutant melanoma, but real-world data in Asian populations are scarce.
Purpose of the Study:
- To evaluate the real-world clinical activity and safety of binimetinib in Japanese patients with advanced NRAS-mutant melanoma.
Main Methods:
- Retrospective analysis of 15 advanced NRAS-mutant melanoma patients treated with binimetinib.
- NRAS mutations confirmed by comprehensive genomic profiling.
- Data collected on demographics, mutation types, treatment response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
Main Results:
- Disease control rate was 60.0% (1 partial response, 8 stable disease).
- Median PFS was 3.1 months; median OS was 4.8 months.
- 93.3% experienced AEs, most commonly skin rash; 26.7% had Grade ≥3 AEs.
Conclusions:
- Binimetinib demonstrated modest clinical activity and manageable safety in this Japanese cohort.
- Outcomes appear comparable to Western populations, suggesting binimetinib's potential role post-immune checkpoint inhibitor therapy.
- Study limitations include retrospective design and small sample size, requiring cautious interpretation.
