Pooled analysis safety profile of nivolumab and ipilimumab combination therapy in patients with advanced melanoma

Journal of Clinical Oncology

Volumn 35, Issue 34, 2017, Pages 3815-3822

  Sznol, Mario ^a   Ferrucci, Pier Francesco ^b   Hogg, David ^d   Atkins, Michael B ^e   Wolter, Pascal ^f   Guidoboni, Massimo ^c   Lebbé, Celeste ^g   Kirkwood, John M ⁱ   Schachter, Jacob ^j   Daniels, Gregory A ^k   Hassel, Jessica ^l   Cebon, Jonathan ^m   Gerritsen, Winald ^n,q   Atkinson, Victoria ^o,p   Thomas, Luc ^h   McCaffrey, John ^r   Power, Derek ^s   Walker, Dana ^t   Bhore, Rafia ^t   Jiang, Joel ^t   Hodi, F Stephen ^u   Wolchok, Jedd D ^v   more..

^a YALE CANCER CENTER   (United States)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^c DEPARTMENT OF MEDICAL ONCOLOGY   (Italy)

^d PRINCESS MARGARET HOSPITAL   (Canada)

^e GEORGETOWN UNIVERSITY   (United States)

^f UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^g UNIVERSITÉ PARIS DESCARTES   (France)

^h CENTRE HOSPITALIER LYON SUD   (France)

ⁱ UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^j SHEBA MEDICAL CENTER   (Israel)

^k UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^l UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^m OLIVIA NEWTON JOHN CANCER RESEARCH INSTITUTE   (Australia)

ⁿ UNIVERSITY OF QUEENSLAND   (Australia)

^o Gallipoli Medical Research Foundation   (Australia)

^p PRINCESS ALEXANDRA HOSPITAL   (Australia)

^q RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^r All Ireland Cooperative Oncology Research Group   (Ireland)

^s Irish Clinical Oncology Research Group   (Ireland)

^t BRISTOL MYERS SQUIBB   (United States)

^u DANA FARBER CANCER INSTITUTE   (United States)

^v MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IPILIMUMAB; NIVOLUMAB; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ADVERSE DRUG REACTION; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER GROWTH; COLITIS; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEVER; FOLLOW UP; HEADACHE; HUMAN; HYPERTHYROIDISM; HYPOPHYSITIS; HYPOTHYROIDISM; LIVER TOXICITY; MACULOPAPULAR RASH; MAJOR CLINICAL STUDY; MELANOMA; METASTATIC MELANOMA; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RASH; RETROSPECTIVE STUDY; TREATMENT DURATION; UNTREATED UNRESECTABLE MELANOMA; VITILIGO; VOMITING; ADULT; AGED; CANCER STAGING; COMBINATION DRUG THERAPY; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; EVALUATION STUDY; FEMALE; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; PARASITOLOGY; PATHOLOGY; PATIENT SAFETY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SKIN TUMOR; SURVIVAL ANALYSIS; TUMOR INVASION;

ADULT; AGED; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IPILIMUMAB; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PATIENT SAFETY; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SKIN NEOPLASMS; SURVIVAL ANALYSIS;

EID: 85034087223     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.72.1167     Document Type: Article

References (25)

1. Wolchok JD, Hodi FS, Weber JS, et al: Development of ipilimumab: A novel immunothera-peutic approach for the treatment of advanced melanoma. Ann N Y Acad Sci 1291:1-13, 2013
2. Hodi FS, O’Day SJ, McDermott DF, et al: Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363:711-723, 2010
3. Robert C, Thomas L, Bondarenko I, et al: Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 364:2517-2526, 2011
4. Wang C, Thudium KB, Han M, et al: In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res 2:846-856, 2014
5. Larkin J, Chiarion-Sileni V, Gonzalez R, et al: Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373: 23-34, 2015
6. Postow MA, Chesney J, Pavlick AC, et al: Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 372:2006-2017, 2015
7. Hodi FS, Chesney J, Pavlick AC, et al: Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, rando-mised, controlled, phase 2 trial. Lancet Oncol 17: 1558-1568, 2016
8. Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al: Updated results from a phase III trial of nivolumab (NIVO) combined with ipilimumab (IPI) in treatment-naïve patients (pts) with advanced melanoma (MEL) (CheckMate 067). J Clin Oncol 34, 2016 (suppl; abstr 9505)
9. Schadendorf D, Larkin J, Postow M, et al: Efficacy and safety outcomes in patients with advanced melanoma (MEL) who discontinued treatment with nivolumab (NIVO) plus ipilimumab (IPI) due to toxicity. Presented at the 12th Congress of the European Association of Dermato Oncology, Vienna, Austria, August 31-September 3, 2016
10. Boutros C, Tarhini A, Routier E, et al: Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nat Rev Clin Oncol 13:473-486, 2016
11. Bristol-Myers Squibb: Opdivo: Immune-mediated adverse reactions management guide, 2015. http://www.opdivohcp.com/servlet/servlet.FileDownload?file=00Pi000000ijs1vEAA
12. Berman D, Korman A, Peck R, et al: The development of immunomodulatory monoclonal antibodies as a new therapeutic modality for cancer: The Bristol-Myers Squibb experience. Pharmacol Ther 148:132-153, 2015
13. Snzol M, Callahan MK, Kluger H, et al: Updated survival, response and safety data in a phase 1 dose-finding study (CA209-004) of concurrent nivolumab (NIVO) and ipilimumab (IPI) in advanced melanoma. Presented at the Society for Melanoma Research (SMR) 2015 International Congress, San Francisco, CA, November 18-21, 2015
14. Weber JS, Hodi FS, Wolchok JD, et al: Safety profile of nivolumab monotherapy: A pooled analysis of patients with advanced melanoma. J Clin Oncol 35:785-792, 2017
15. Weber JS, Kähler KC, Hauschild A: Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 30: 2691-2697, 2012
16. Johnson DB, Balko JM, Compton ML, et al: Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med 375:1749-1755, 2016
17. Hodi FS, Postow MA, Chesney JA, et al: Overall survival in patients with advanced melanoma (MEL) who discontinued treatment with nivolumab (NIVO) plus ipilimumab (IPI) due to toxicity in a phase II trial (CheckMate 069). J Clin Oncol 34, 2016 (suppl; abstr 9518)
18. Downey SG, Klapper JA, Smith FO, et al: Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res 13: 6681-6688, 2007
19. Bronstein Y, Ng CS, Hwu P, et al: Radiologic manifestations of immune-related adverse events in patients with metastatic melanoma undergoing anti-CTLA-4 antibody therapy. AJR Am J Roentgenol 197: W992-W1000, 2011
20. Sarnaik AA, Yu B, Yu D, et al: Extended dose ipilimumab with a peptide vaccine: Immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma. Clin Cancer Res 17:896-906, 2011
21. Weber J, Thompson JA, Hamid O, et al: A randomized, double-blind, placebo-controlled, phase II studycomparingthetolerabilityandefficacyofipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 15:5591-5598, 2009
22. Phan GQ, Yang JC, Sherry RM, et al: Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A 100:8372-8377, 2003
23. Ascierto PA, Simeone E, Sileni VC, et al: Clinical experience with ipilimumab 3 mg/kg: Real-world efficacy and safety data from an expanded access programme cohort. J Transl Med 12:116, 2014
24. Horvat TZ, Adel NG, Dang TO, et al: Immune-related adverse events, need for systemic immunosuppression, and effects on survival and time to treatment failure in patients with melanoma treated with ipilimumab at Memorial Sloan Kettering Cancer Center. J Clin Oncol 33:3193-3198, 2015
25. Freeman-Keller M, Kim Y, Cronin H, et al: Nivolumab in resected and unresectable metastatic melanoma: Characteristics of immune-related adverse events and association with outcomes. Clin Cancer Res 22:886-894, 2016