Melanoma, NRAS-mutated
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| Page editor | Section editor | ||
|---|---|---|---|
 |
Ryan Nguyen, DO University of Illinois at Chicago Chicago, IL, USA |
 |
Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA, USA |
Note: these were regimens tested in patients with NRAS-mutated melanoma, please see the main melanoma page for other regimens.
| Last updated on 2024-07-23: 2 regimens on this page
2 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Melanoma: Cutaneous.
Advanced or metastatic disease, TKI-naive
Binimetinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Ascierto et al. 2013 (CMEK162X2201) | 2011-2012 | Phase 2 | ||
| Dummer et al. 2017 (NEMO) | 2013-2015 | Phase 3 (E-switch-ooc) | Dacarbazine | Superior PFS (primary endpoint) Median PFS: 2.8 vs 1.5 mo (HR 0.62, 95% CI 0.47-0.80) |
Note: dosing is different for BRAF mutations (45 to 60 mg twice per day)
Biomarker eligibility criteria
- Gene: NRAS or BRAF
- Alteration: mutation [Val600 BRAF]
References
- CMEK162X2201: Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. Epub 2013 Feb 13. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01320085
- NEMO: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01763164
Dacarbazine monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Dummer et al. 2017 (NEMO) | 2013-2015 | Phase 3 (C) | Binimetinib | Inferior PFS |
References
- NEMO: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01763164