Difference between revisions of "Melanoma, NRAS-mutated"
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)] | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)] | ||
|2013-2015 | |2013-2015 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (E-switch-ooc) |
|[[#Dacarbazine_monotherapy|Dacarbazine]] | |[[#Dacarbazine_monotherapy|Dacarbazine]] | ||
| style="background-color:#1a9850" |Superior PFS | | style="background-color:#1a9850" |Superior PFS | ||
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)] | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)] | ||
|2013-2015 | |2013-2015 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[#Binimetinib_monotherapy|Binimetinib]] | |[[#Binimetinib_monotherapy|Binimetinib]] | ||
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS |
Revision as of 02:24, 16 December 2021
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
|
Advanced or metastatic disease, TKI-naive
Binimetinib monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Ascierto et al. 2013 (CMEK162X2201) | 2011-2012 | Phase II | ||
Dummer et al. 2017 (NEMO) | 2013-2015 | Phase 3 (E-switch-ooc) | Dacarbazine | Superior PFS |
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 protocol 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 protocol PubMed NCT01763164
Dacarbazine monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Dummer et al. 2017 (NEMO) | 2013-2015 | Phase 3 (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 NCT01763164