Pembrolizumab for the treatment of advanced melanoma

Expert Opinion on Orphan Drugs

Volumn 4, Issue 8, 2016, Pages 867-873

  Burns, Michael C ^a   O’donnell, Aidan ^a   Puzanov, Igor ^b  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Immunotherapy; pembrolizumab; programmed death 1; programmed death ligand 1

Indexed keywords

EPACADOSTAT; IPILIMUMAB; PEMBROLIZUMAB;

ADVANCED CANCER; ANEMIA; ARTICLE; CANCER PATIENT; DECREASED APPETITE; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG USE; FATIGUE; HUMAN; MELANOMA; NAUSEA; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; SOLID TUMOR; TREATMENT RESPONSE;

EID: 84976294109     PISSN: None     EISSN: 21678707     Source Type: Journal    
DOI: 10.1080/21678707.2016.1191348     Document Type: Article

References (32)

1. C.M.Balch, J.E.Gershenwald, S.J.Soong, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol. 2009 Dec 20;27(36):6199–6206.
2. P.B.Chapman, A.Hauschild, C.Robert, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507–2516.
3. A.Hauschild, J.J.Grob, L.V.Demidov, 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.
4. K.B.Kim, R.Kefford, A.C.Pavlick, et al. Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor. J Clin Oncol. 2013 Feb 1;31(4):482–489.
5. J.Larkin, P.A.Ascierto, B.Dréno, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867–1876.
6. G.V.Long, D.Stroyakovskiy, H.Gogas, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877–1888.
7. F.S.Hodi, S.J.O’Day, D.F.McDermott, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711–723.• Positive phase II trial of ipilimumab for the treatment of metastatic melanoma.
8. C.Robert, L.Thomas, I.Bondarenko, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517–2526.• Second positive phase II trial of ipilimumab for the treatment of metastatic melanoma.
9. D.Schadendorf, F.S.Hodi, C.Robert, et al. Pooled analysis of long-term survival data from Phase II and Phase III trials of ipilimumab in unresectable or metastatic melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889–1894.
10. C.Robert, B.Karaszewska, J.Schachter, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30–39.
11. G.V.Long, D.Stroyakovskiy, H.Gogas, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma:a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015 Aug 1;386(9992):444–451.
12. I.Puzanov, R.K.Amaravadi, G.A.McArthur, et al. Long-term outcome in BRAF(V600E) melanoma patients treated with vemurafenib:patterns of disease progression and clinical management of limited progression. Eur J Cancer. 2015 Jul;51(11):1435–1443.
13. G.V.Long, J.S.Weber, J.R.Infante, et al. Overall survival and durable responses in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib combined with trametinib. J Clin Oncol. 2016;34(8):871–878.
14. C.Robert, G.V.Long, B.Brady, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320–330.
15. J.S.Weber, S.P.D’Angelo, D.Minor, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037):a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375–384.
16. J.Larkin, V.Chiarion-Sileni, R.Gonzalez, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015 Jul 2;373(1):23–34.
17. D.Hanahan, R.A.Weinberg Hallmarks of cancer:the next generation. Cell. 2011 Mar 4;144(5):646–674.
18. Y.Ishida, Y.Agata, K.Shibahara, et al. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J. 1992 Nov;11(11):3887–3895.
19. O.Hamid, C.Robert, A.Daud, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013 Jul 11;369(2):134–144.•• Phase I trial of pembrolizumab in melanoma demonstrating acceptable safety profile.
20. G.Scapin, X.Yang, W.W.Prosise, et al. Structure of full-length human anti-PD1 therapeutic IgG4 antibody pembrolizumab. Nat Struct Mol Biol. 2015 Dec;22(12):953–958.
21. A.Patnaik, S.P.Kang, D.Rasco, et al. Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res. 2015 Oct 1;21(19):4286–4293.• Pharmacokinetics and pharmacodynamics of pembrolizumab studied in the initial dose escalation phase of KEYNOTE-001.
22. KEYTRUDA® (pembrolizumab) for injection, for intravenous use [prescribing information]. Whitehouse Station, NJ:Merck Sharp & Dohme Corp, a subsidiary of Merck & Co. [Revised:12/2015].
23. J.D.Wolchok, A.Hoos, S.O’Day, et al. Guidelines for the evaluation of immune therapy activity in solid tumors:immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412–7420.
24. C.Robert, A.Ribas, J.D.Wolchok, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma:a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014 Sep 20;384(9948):1109–1117.•• Results reported from the randomized dose-comparison cohort of KEYNOTE-001 for patients with ipilimumab-refractory melanoma.
25. O.Hamid, C.Robert, A.Ribas, et al. Randomized comparison of two doses of the anti-PD-1 monoclonal antibody MK-3475 for ipilimumab-refractory (IPI-R) and IPI-naive (IPI-N) melanoma (MEL). ASCO Meet Abstr. 2014 Jun 11;32(15_suppl):3000.
26. C.Robert, A.M.Joshua, J.S.Weber, et al. LBA34PEMBROLIZUMAB (PEMBRO; MK-3475) for advanced melanoma (MEL):randomized comparison of two dosing schedules. Ann Oncol. 2014;25(suppl 4).
27. A.Ribas, I.Puzanov, R.Dummer, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002):a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908–918.•• Results from KEYNOTE-002, a randomized phase II study, established pembrolizumab as the standard of care for the treatment of ipilimumab-refractory melanoma.
28. C.Robert, J.Schachter, G.V.Long, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015 Jun 25;372(26):2521–2532.•• Results from a randomized, controlled, phase III study (KEYNOTE-006) helped establish pembrolizumab as a frontline treatment option.
29. M.B.Atkins, T.K.Choueiri, F.S.Hodi, et al. Pembrolizumab (MK-3475) plus low-dose ipilimumab (IPI) in patients (pts) with advanced melanoma (MEL) or renal cell carcinoma (RCC):Data from the KEYNOTE-029 phase 1 study. ASCO Meet Abstr. 2015 May 18;33(15_suppl):3009.
30. T.Gangadhar, O.Hamid, D.Smith, et al. Preliminary results from a Phase I/II study of epacadostat (incb024360) in combination with pembrolizumab in patients with selected advanced cancers. J ImmunoTher Cancer. 2015;3(Suppl 2):O7.
31. G.V.Long, R.Dummer, A.Ribas, et al. Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec and pembrolizumab for unresectable stage IIIB-IV melanoma. Soc Melanoma Res 2015 Congr Pigm Cell Melanoma Res. 2015;28:753–826.
32. S.L.Topalian, J.M.Taube, R.A.Anders, et al. Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy. Nat Rev Cancer. 2016;16(5):275–287.