Melanoma, NRAS-mutated
Revision as of 20:23, 11 August 2023 by Warner-admin (talk | contribs) (Text replacement - ":Section editor transclusions|" to ":Editorial board transclusions|")
| Page editor | Section editor | ||
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Ryan Nguyen, DO University of Illinois at Chicago Chicago, IL, USA |
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Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA, USA |
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
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]
Targeted therapy
- Binimetinib (Mektovi) 45 mg PO twice per day
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 contains dosing details in abstract 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 contains dosing details in abstract 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 contains dosing details in abstract PubMed NCT01763164