Melanoma, NRAS-mutated
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Section editor | |
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Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA |
Note: these are regimens tested in biomarker-specific populations, please see the main melanoma page for other regimens.
2 regimens on this page
2 variants on this page
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Advanced or metastatic disease, TKI-naive
Binimetinib monotherapy
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
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Ascierto et al. 2013 | Phase II | ||
Dummer et al. 2017 (NEMO) | Phase III (E-switch-ooc) | Dacarbazine | Superior PFS |
Chemotherapy
- Binimetinib (Mektovi) 45 mg PO twice per day for NRAS mutation; 45-60 mg twice a day for BRAF mutations
Biomarker eligibility criteria
- Gene: NRAS or BRAF
- Alteration: mutation [Val600 BRAF]
References
- 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 contains protocol PubMed
- 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 contains protocol PubMed
Dacarbazine monotherapy
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
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Dummer et al. 2017 (NEMO) | Phase III (C) | Binimetinib | Inferior PFS |
Chemotherapy
- Dacarbazine (DTIC) 1000 mg/m2 IV once on day 1
21-day cycles
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 contains protocol PubMed