An overview of binimetinib for the treatment of melanoma

References

• MEKTOVI EPAR Public assessment report. European Medicines Agency. [cited 2020 Jan 31]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/mektovi-epar-public-assessment-report_en.pdf
   Google Scholar
• Greaves WO, Verma S, Patel KP, et al. Frequency and spectrum of BRAF mutations in a retrospective, single-institution study of 1112 cases of melanoma. J Mol Diagn. 2013 Mar;15(2):220–226.
   PubMed Web of Science ®Google Scholar
• Colombino M, Capone M, Lissia A, et al. BRAF/NRAS mutation frequencies among primary tumors and metastases in patients with melanoma. J Clin Oncol. 2012 Jul 10;30(20):2522–2529.
   PubMed Web of Science ®Google Scholar
• Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun 27;417(6892):949–954.
   PubMed Web of Science ®Google Scholar
• Jakob JA, Bassett RL Jr., Ng CS, et al. NRAS mutation status is an independent prognostic factor in metastatic melanoma. Cancer. 2012 Aug 15;118(16):4014–4023.
   PubMed Web of Science ®Google Scholar
• Zbytek B, Carlson JA, Granese J, et al. Current concepts of metastasis in melanoma. Expert Rev Dermatol. 2008 Oct;3(5):569–585.
   PubMedGoogle Scholar
• Peyssonnaux C, Eychene A. The Raf/MEK/ERK pathway: new concepts of activation. Biol Cell. 2001 Sep;93(1–2):53–62.
   PubMed Web of Science ®Google Scholar
• Robert C, Grob JJ, Stroyakovskiy D, et al. Five-year outcomes with dabrafenib plus trametinib in metastatic melanoma. N Engl J Med. 2019 Aug 15;381(7):626–636.
   PubMed Web of Science ®Google Scholar
• Long GV, Flaherty KT, Stroyakovskiy D, et al. Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study. Ann Oncol. 2017 Jul 1;28(7):1631–1639.
   PubMed Web of Science ®Google Scholar
• Chapman PB, Robert C, Larkin J, et al. Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study. Ann Oncol. 2017 Oct 1;28(10):2581–2587.
   PubMed Web of Science ®Google Scholar
• Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480–1492.
   PubMed Web of Science ®Google Scholar
• Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711–723.
   PubMed Web of Science ®Google Scholar
• Larkin J, Ascierto PA, Dreno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867–1876.
   PubMed Web of Science ®Google Scholar
• Ascierto PA, McArthur GA, Dreno B, et al. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1248–1260.
   PubMed Web of Science ®Google Scholar
• Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507–2516.
   PubMed Web of Science ®Google Scholar
• Hauschild A, Grob JJ, Demidov LV, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358–365.
   PubMed Web of Science ®Google Scholar
• Long GV, Stroyakovskiy D, Gogas H, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877–1888.
   PubMed Web of Science ®Google Scholar
• Flaherty KT, Robert C, Hersey P, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107–114.
   PubMed Web of Science ®Google Scholar
• Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma. 10 Spring Gardens. London: National Institute for Health and Care Excellence. [cited 2020 Jan 31]. Available from: https://www.nice.org.uk/guidance/ta562/evidence/committee-papers-pdf-6713810029
   Google Scholar
• Ascierto PA, Schadendorf D, Berking C, et al. 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):249–256.
   PubMed Web of Science ®Google Scholar
• van Herpen CML, Agarwala SS, Hauschild A, et al. Biomarker results from a phase II study of MEK1/2 inhibitor binimetinib (MEK162) in patients with advanced. Oncotarget. 2019 Mar 5;10(19):1850–1859.
   PubMedGoogle Scholar
• Dummer R, Schadendorf D, Ascierto PA, et al. 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.
   PubMed Web of Science ®Google Scholar
• Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):603–615.
   PubMed Web of Science ®Google Scholar
• Dummer R, Ascierto P, Gogas H, et al. Results of COLUMBUS Part 2: a phase 3 trial of encorafenib (ENCO) plus binimetinib (BINI) versus ENCO in BRAF-mutant melanoma. Ann.Oncol. 2017;28(suppl 5). abstract 1215O, 429.
   Google Scholar
• Dummer R, Ascierto PA, Gogas HJ, et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1315–1327.
   PubMed Web of Science ®Google Scholar
• Liszkay G, Gogas H, Mandala M, et al. Update on overall survival in COLUMBUS: a randomized phase III trial of encorafenib (ENCO) plus binimetinib (BINI) versus vemurafenib (VEM) or ENCO in patients with BRAF V600–mutant melanoma. J Clin Oncol. 2019;37(suppl):9512. abstract 9512.
   Google Scholar
• Highlights of prescribing information. US Food and Drug Administration. [cited 2020 Jan 31]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf
   Google Scholar
• MEKTOVI EPAR Product information. European Medicines Agency. [cited 2020 Jan 31]. Available from: https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf
   Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019 Oct 17;381(16):1535–1546.
   PubMed Web of Science ®Google Scholar
• Dabrafenib and trametinib followed by ipilimumab and nivolumab or ipilimumab and nivolumab followed by dabrafenib and trametinib in treating patients with stage III-IV BRAFV600 melanoma. ClinicalTrials.gov. US National Library of Medicine. [cited 2020 Jan 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT02224781
   Google Scholar
• Immunotherapy with ipilimumab and nivolumab preceded or not by a targeted therapy with encorafenib and binimetinib (EBIN). ClinicalTrials.gov. US National Library of Medicine. [cited 2020 Jan 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT03235245
   Google Scholar
• INTERIM: a randomised phase II feasibility study of INTERmittent versus continuous dosing of oral targeted combination therapy In patients with BRAFV600 mutant stage 3 unresectable or metastatic melanoma. ClinicalTrials.gov. US National Library of Medicine. [cited 2020 Jan 31]. Available from: https://clinicaltrials.gov/ProvidedDocs/47/NCT03352947/Prot_000.pdf
   Google Scholar
• Specenier P, van Gogh E. Adjuvant treatment of stage III melanoma: a tabulated review of randomised phase III trials. Belg J Med Oncol. 2020;14(1):8–12.
   Google Scholar
• Weber J, Mandala M, Del VM, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017 Nov 9;377(19):1824–1835.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018 May 10;378(19):1789–1801.
   PubMed Web of Science ®Google Scholar
• Hauschild A, Dummer R, Schadendorf D, et al. Longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600-mutant stage III melanoma. J Clin Oncol. 2018;36:3441–3449.
   Web of Science ®Google Scholar
• Davies MA, Saiag P, Robert C, et al. Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 July;18(7):863–873.
   PubMed Web of Science ®Google Scholar
• Davies MA, Saiag P, Long GV. Primary medical therapy for BRAF(V600E)-mutant melanoma brain metastases-is this good enough? – authors’ reply. Lancet Oncol. 2017 Sep;18(9):e509.
   PubMed Web of Science ®Google Scholar
• Tawbi HA, Forsyth PA, Algazi A, et al. Combined nivolumab and ipilimumab in melanoma metastatic to the brain. N Engl J Med. 2018 Aug 23;379(8):722–730.
   PubMed Web of Science ®Google Scholar
• Tawbi HA, Chung C, Nivolumab MK. Ipilimumab in melanoma metastatic to the brain. N Engl J Med. 2018 Nov 29;379(22):2178.
   PubMed Web of Science ®Google Scholar
• Long GV, Atkinson V, Lo S, et al. Long-term outcomes from the randomized phase II study of nivolumab (nivo) or nivo+ipilimumab (ipi) in patients (pts) with melanoma brain metastases (mets): anti-PD1 brain collaboration (ABC). Ann.Oncol. 2019;30(Suppl 5):1311O. (Abstract).
   PubMedGoogle Scholar