Ipilimumab combined with nivolumab: A standard of care for the treatment of advanced melanoma?

Clinical Cancer Research

Volumn 22, Issue 16, 2016, Pages 3992-3998

  Carlino, Matteo S ^a   Long, Georgina V ^a  

^a UNIVERSITY OF SYDNEY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DABRAFENIB; DACARBAZINE; EPACADOSTAT; GLYCOPROTEIN GP 100; IPILIMUMAB; NIVOLUMAB; PEMBROLIZUMAB; PLACEBO; PROGRAMMED DEATH 1 RECEPTOR; TALIMOGENE LAHERPAREPVEC; TRAMETINIB; ANTINEOPLASTIC AGENT; CTLA4 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; TUMOR MARKER;

ADVANCED CANCER; ARTICLE; CANCER PATIENT; DRUG APPROVAL; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOTOXICITY; MELANOMA; OVERALL SURVIVAL; PATIENT SELECTION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REPEATED DRUG DOSE; T LYMPHOCYTE; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL (TOPIC); HEALTH CARE QUALITY; METABOLISM; MOLECULARLY TARGETED THERAPY; MORTALITY; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS, TUMOR; CLINICAL TRIALS AS TOPIC; CTLA-4 ANTIGEN; HUMANS; IPILIMUMAB; MELANOMA; MOLECULAR TARGETED THERAPY; PATIENT SELECTION; PROGRAMMED CELL DEATH 1 RECEPTOR; STANDARD OF CARE; TREATMENT OUTCOME;

EID: 84982083101     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-15-2944     Document Type: Article

References (40)

1. Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Atkins MB, Byrd DR, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009;27:6199-206.
2. Chen L. Co-inhibitory molecules of the B7-CD28 family in the control of Tcell immunity. Nat Rev Immunol 2004;4:336-47.
3. Lee KM, Chuang E, Griffin M, Khattri R, Hong DK, Zhang W, et al. Molecular basis of T cell inactivation by CTLA-4. Science 1998;282:2263-6.
4. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survivalwith ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
5. Robert C, Thomas L, Bondarenko I, O'Day S, M DJ, Garbe C, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011;364:2517-26.
6. Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, 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;33:1889-94.
7. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009;15:7412-20.
8. Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol 2008;8:467-77.
9. Casey SC, Tong L, Li Y, Do R, Walz S, Fitzgerald KN, et al. MYC regulates the antitumor immune response through CD47 and PD-L1. Science 2016;352: 227-31.
10. Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, 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;16:375-84.
11. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015;373:23-34.
12. Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 2015;372:2521-32.
13. Waterhouse P, Penninger JM, Timms E, Wakeham A, Shahinian A, Lee KP, et al. Lymphoproliferative disorders with early lethality in mice deficient in Ctla-4. Science 1995;270:985-8.
14. Nishimura H, Nose M, Hiai H, Minato N, Honjo T. Development of lupuslike autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity 1999;11:141-51.
15. Nishimura H, Okazaki T, Tanaka Y, Nakatani K, Hara M, Matsumori A, et al. Autoimmune dilated cardiomyopathy in PD-1 receptor-deficient mice. Science 2001;291:319-22.
16. Curran MA, Montalvo W, Yagita H, Allison JP. PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanoma tumors. Proc Natl Acad Sci U S A 2010;107:4275-80.
17. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013;369:122-33.
18. Sznol M, Kluger HM, Callahan MK, Postow MA, Gordon RA, Segal NH, et al. Survival, response duration, and activity by BRAF mutation (MT) status of nivolumab (NIVO, anti-PD-1, BMS-936558, ONO-4538) and ipilimumab (IPI) concurrent therapy in advanced melanoma (MEL). J Clin Oncol 32:5s, 2014 (suppl; abstr LBA9003).
19. Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 2015;372:2006-17.
20. Postow M, Chesney J, Pavlick A, Robert C, Grossmann K, McDermott D, et al. Initial report of overall survival rates from a randomized phase II trial evaluating the combination of nivolumab (NIVO) and ipilimumab (IPI) in patients with advanced melanoma (MEL) [abstract]. In: Proceedings of the 107th AnnualMeeting of the American Association for Cancer Research (AACR); 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; 2016. Abstract nr CT002.
21. Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, et al. Updated results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067). J Clin Oncol 34, 2016 (suppl; abstr 9505).
22. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, et al. Efficacy and safety in key patient subgroups of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naive patients with advanced melanoma (MEL) (CheckMate 067). Eur J Cancer 2015;51:S664-S5.
23. Weber JS, Gibney G, Sullivan RJ, Sosman JA, Slingluff CL Jr, Lawrence DP, et al. Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advancedmelanoma (CheckMate 064): an open-label, randomised, phase 2 trial. Lancet Oncol 2016;17:943-55.
24. Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Ernstoff M, et al. Expanded cohort results from CheckMate 016: a phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma (mRCC). J Clin Oncol 33, 2015(suppl; abstr 4516).
25. Antonia SJ, Gettinger SN, Chow LQM, Juergens RA, Borghaei H, Shen Y, et al. Nivolumab (anti-PD-1; BMS-936558, ONO-4538) and ipilimumab in first-line NSCLC: interim phase I results. J Clin Oncol 32:5s, 2014(suppl; abstr 8023).
26. Atkins MB, Choueiri TK, Hodi FS, Thompson JA, Hwu W-J, McDermott DF, 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. J Clin Oncol 33, 2015 (suppl; abstr 3009).
27. Long GV, Atkinson V, Cebon JS, Jameson MB, Fitzharris BM, McNeil CM, et al. Pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma: results of the KEYNOTE-029 expansion cohort. J Clin Oncol 34, 2016(suppl; abstr 9506).
28. Antonia SJ, Goldberg SB, Balmanoukian AS, Sanborn RE, Steele K, Narwal R, et al. Phase Ib study of MEDI4736, a programmed cell death ligand-1 (PD-L1) antibody, in combination with tremelimumab, a cytotoxic Tlymphocyte- associated protein-4 (CTLA-4) antibody, in patients (pts) with advanced NSCLC. J Clin Oncol 33, 2015(suppl; abstr 3014).
29. Larkin J, D'Angelo SP, Sosman JA, Lebbé C, Brady B, Neyns B, et al. Efficacy and safety of nivolumab alone or in combination with ipilimumab in the treatment of advanced mucosal melanoma [abstract]. In: Proceedings of the Society for Melanoma Research 2015 Congress; 2015 Nov 18-21; San Francisco, CA. Clifton Park (NY): The Society for Melanoma Research; 2015. Available from: http://onlinelibrary.wiley.com/doi/10.1111/pcmr.12419/epdf.
30. Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 2014;515:568-71.
31. McGranahan N, Furness AJ, Rosenthal R, Ramskov S, Lyngaa R, Saini SK, et al. Clonal neoantigens elicit T cell immunoreactivity and sensitivity to immune checkpoint blockade. Science 2016;351:1463-9.
32. Vilain RE, Kakavand H, Menzies AM, Madore J, Wilmott J, Dobney R, et al. PD1 inhibition-induced changes in melanoma and its associated immune infiltrate. Eur J Cancer 2015;51:S666-S.
33. Hellmann MD, Friedman CF, Wolchok JD. Combinatorial cancer immunotherapies. Adv Immunol 2016;130:251-77.
34. Spranger S, Koblish H, Horton B, Scherle P, Newton R, Gajewski T. Mechanism of tumor rejection with doublets of CTLA-4, PD-1/PD-L1, or IDO blockade involves restored IL-2 production and proliferation of CD8+ T cells directly within the tumor microenvironment. J Immunother Cancer 2014;2:3.
35. Hamid O, Gajewski T, Smith D, Bauer T, Wasser J, Luke J, et al. Preliminary data from a phase 1/2 study of epacadostat (INCB024360) with pembrolizumab in patients with advanced/metastaticmelanoma [abstract]. In: Proceedings of the Society for Melanoma Research 2015 Congress; 2015 Nov 18-21; San Francisco, CA. Clifton Park (NY): The Society for Melanoma Research; 2015. Available from: http://onlinelibrary.wiley.com/doi/10.1111/pcmr.12419/epdf.
36. Long GV, Dummer R, Ribas A, Puzanov I, VanderWalde A, Andtbacka RHI, et al. Efficacy analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma. J Clin Oncol 34, 2016(suppl; abstr 9568).
37. Hu-Lieskovan S, Mok S, Homet Moreno B, Tsoi J, Robert L, Goedert L, et al. Improved antitumor activity of immunotherapy with BRAF and MEK inhibitors in BRAF(V600E) melanoma. Sci Transl Med 2015;7: 279ra41.
38. Ribas A, Hodi FS, Lawrence DP, Atkinson V, Starodub A, Carlino MS, et al. Pembrolizumab (pembro) in combination with dabrafenib (D) and trametinib (T) for BRAF-mutant advanced melanoma: Phase 1 KEYNOTE- 022 study. J Clin Oncol 34, 2016(suppl; abstr 3014).
39. Teng MW, Ngiow SF, Ribas A, Smyth MJ. Classifying cancers based on T-cell infiltration and PD-L1. Cancer Res 2015;75:2139-45.
40. Gray ES, Rizos H, Reid AL, Boyd SC, Pereira MR, Lo J, et al. Circulating tumor DNA to monitor treatment response and detect acquired resistance in patients with metastatic melanoma. Oncotarget 2015;6: 42008-18.