Difference between revisions of "Melanoma, NRAS-mutated"

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#'''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. [https://doi.org/10.1016/S1470-2045(13)70024-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23414587/ PubMed] [https://clinicaltrials.gov/study/NCT01320085 Clinical Trial Registry]
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#'''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. [https://doi.org/10.1016/S1470-2045(13)70024-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23414587/ PubMed] [https://clinicaltrials.gov/study/NCT01320085 NCT01320085]
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#'''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. [https://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract'''  [https://pubmed.ncbi.nlm.nih.gov/28284557/ PubMed] [https://clinicaltrials.gov/study/NCT01763164 Clinical Trial Registry]
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#'''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. [https://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract'''  [https://pubmed.ncbi.nlm.nih.gov/28284557/ PubMed] [https://clinicaltrials.gov/study/NCT01763164 NCT01763164]
 
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==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}==
 
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#'''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. [https://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28284557/ PubMed] [https://clinicaltrials.gov/study/NCT01763164 Clinical Trial Registry]
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#'''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. [https://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28284557/ PubMed] [https://clinicaltrials.gov/study/NCT01763164 NCT01763164]
 
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[[Category:Melanoma regimens]]
 
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Revision as of 12:16, 4 July 2023

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Section editor transclusions 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

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
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

References

  1. 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
  2. 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

Chemotherapy

21-day cycles

References

  1. 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
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