Melanoma, NRAS-mutated

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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	Longer 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
21-day cycles
===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 manuscript have been reviewed by our editors EuroPMC 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 EuroPMC NCT01763164
==Dacarbazine monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Dummer et al. 2017 (NEMO)	2013-2015 	Phase 3 (C)	Binimetinib	Shorter PFSMedian PFS: 1.5 vs 2.8 mo(HR 1.61, 95% CI 1.25-2.13)
====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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT01763164
Category:Melanoma regimens
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Category:Skin cancers