Safety of Combination Immune Checkpoint Inhibitors Compared to Monotherapy; A Systematic Review and Meta-Analysis

References

• Harris TJ, Drake CG. Primer on tumor immunology and cancer immunotherapy. J Immunother Cancer. 2013;1:12. doi:10.1186/2051-1426-1-12.
   PubMedGoogle Scholar
• Linsley PS, Brady W, Urnes M, Grosmaire LS, Damle NK, Ledbetter JA. CTLA-4 is a second receptor for the B cell activation antigen B7. J Exp Med. 1991;174:561–569. doi:10.1084/jem.174.3.561.
   PubMed Web of Science ®Google Scholar
• Qureshi OS, Zheng Y, Nakamura K, Attridge K, Manzotti C, Schmidt EM, et al. Trans-endocytosis of CD80 and CD86: a molecular basis for the cell-extrinsic function of CTLA-4. Science. 2011;332:600–603. doi:10.1126/science.1202947.
   PubMed Web of Science ®Google Scholar
• Riley JL, Mao M, Kobayashi S, Biery M, Burchard J, Cavet G, et al. Modulation of TCR-induced transcriptional profiles by ligation of CD28, ICOS, and CTLA-4 receptors. Proc Natl Acad Sci USA. 2002;99:11790–11795. doi:10.1073/pnas.162359999.
   PubMed Web of Science ®Google Scholar
• Schneider H, Downey J, Smith A, Zinselmeyer BH, Rush C, Brewer JM, et al. Reversal of the TCR stop signal by CTLA-4. Science. 2006;313:1972–1975. doi:10.1126/science.1131078.
   PubMed Web of Science ®Google Scholar
• Bardhan K, Anagnostou T, Boussiotis VA. The PD1:PD-L1/2 pathway from discovery to clinical implementation. Front Immunol. 2016;7:550. doi:10.3389/fimmu.2016.00550.
   PubMed Web of Science ®Google Scholar
• Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723. doi:10.1056/NEJMoa1003466.
   PubMed Web of Science ®Google Scholar
• Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator’s choice chemotherapy in CheckMate 037: a randomized, controlled, open-label phase III trial. J Clin Oncol. 2018;36:383–390. doi:10.1200/JCO.2016.71.8023.
   PubMed Web of Science ®Google Scholar
• Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, et al. Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017;35:3924–3933. doi:10.1200/JCO.2017.74.3062.
   PubMed Web of Science ®Google Scholar
• Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, et al. CheckMate 025 randomized phase 3 study: outcomes by key baseline factors and prior therapy for nivolumab versus everolimus in advanced renal cell carcinoma. Eur Urol. 2017;72:962–971. doi:10.1016/j.eururo.2017.02.010.
   PubMed Web of Science ®Google Scholar
• Kumar P, Bhattacharya P, Prabhakar BS. A comprehensive review on the role of co-signaling receptors and Treg homeostasis in autoimmunity and tumor immunity. J Autoimmun. 2018;95:77–99. doi:10.1016/j.jaut.2018.08.007.
   PubMed Web of Science ®Google Scholar
• Hodi FS, Chesney J, Pavlick AC, Robert C, Grossmann KF, Mcdermott DF, et al. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016;17:1558–1568. doi:10.1016/S1470-2045(16)30366-7.
   PubMed Web of Science ®Google Scholar
• 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;372:2006–2017. doi:10.1056/NEJMoa1414428.
   PubMed Web of Science ®Google Scholar
• Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, 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;19:1480–1492. doi:10.1016/S1470-2045(18)30700-9.
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1056/NEJMoa1504030.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob J-J, Cowey CL, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377:1345–1356. doi:10.1056/NEJMoa1709684.
   PubMed Web of Science ®Google Scholar
• Long GV, Atkinson V, Lo S, Sandhu S, Guminski AD, Brown MP, et al. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018;19:672–681. doi:10.1016/S1470-2045(18)30139-6.
   PubMed Web of Science ®Google Scholar
• Amaria RN, Reddy SM, Tawbi HA, Davies MA, Ross MI, Glitza IC, et al. Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma. Nat Med. 2018;24:1649–1654. doi:10.1038/s41591-018-0197-1.
   PubMed Web of Science ®Google Scholar
• Angelo SPD, Mahoney MR, Tine BA, Van Atkins J, Milhem MM, Jahagirdar BN, et al. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018;19:416–426. doi:10.1016/S1470-2045(18)30006-8.
   PubMed Web of Science ®Google Scholar
• Hellmann MD, Ciuleanu T-E, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med. 2018;378:2093–2104. doi:10.1056/NEJMoa1801946.
   PubMed Web of Science ®Google Scholar
• Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, et al. CheckMate-032 study: efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer. J Clin Oncol. 2018;36:2836–2844. doi:10.1200/JCO.2017.76.6212.
   PubMed Web of Science ®Google Scholar
• Antonia SJ, López-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016;17:883–895. doi:10.1016/S1470-2045(16)30098-5.
   PubMed Web of Science ®Google Scholar
• Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Dô P, Bylicki O, et al. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2). Lancet Oncol. 2019;20:1–15. doi:10.1016/S1470-2045(18)30765-4.
   PubMed Web of Science ®Google Scholar
• Zhou S, Khanal S, Zhang H. Risk of immune-related adverse events associated with ipilimumab-plus-nivolumab and nivolumab therapy in cancer patients. Ther Clin Risk Manag. 2019;15:211–221. doi:10.2147/TCRM.S193338.
   PubMed Web of Science ®Google Scholar