Avelumab for the treatment of urothelial cancer

References

• Ploeg M, Aben KK, Kiemeney LA. The present and future burden of urinary bladder cancer in the world. World J Urol. 2009;27(3):289–293.
   PubMed Web of Science ®Google Scholar
• Muñoz JJ, Ellison LM. Upper tract urothelial neoplasms: incidence and survival during the last 2 decades. J Urol. 2000;164(5):1523–1525.
   PubMed Web of Science ®Google Scholar
• Freedman ND, Silverman DT, Hollenbeck AR, et al. Association between smoking and risk of bladder cancer among men and women. JAMA. 2011;306(7):737–745.
   PubMed Web of Science ®Google Scholar
• Ferlay J, Shin H-R, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010;127(12):2893–2917.
   PubMed Web of Science ®Google Scholar
• Witjes JA, Compérat E, Cowan NC, et al. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 2014;65(4):778–792.
   PubMed Web of Science ®Google Scholar
• Abouassaly R, Alibhai SM, Shah N, et al. Troubling outcomes from population-level analysis of surgery for upper tract urothelial carcinoma. Urology. 2010;76(4):895–901.
   PubMed Web of Science ®Google Scholar
• Loehrer PJ, Einhorn LH, Elson PJ, et al. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992;10(7):1066–1073.
   PubMed Web of Science ®Google Scholar
• Von der Maase H, Sengelov L, Roberts JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602–4608.
   PubMed Web of Science ®Google Scholar
• de Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012;30(2):191–199.
   PubMed Web of Science ®Google Scholar
• Bellmunt J, Théodore C, Demkov T, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009;27(27):4454–4461.
   PubMed Web of Science ®Google Scholar
• Sweeney CJ, Roth BJ, Kabbinavar FF, et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006;24(21):3451–3457.
   PubMed Web of Science ®Google Scholar
• Joly F, Houédé N, Noal S, et al. Do patients with advanced urothelial carcinoma benefit from weekly paclitaxel chemotherapy? A GETUG phase II study. Clin Genitourin Cancer. 2009;7(2):E28–33.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Ross RW, Jacobus S, et al. Double-blind, randomized trial of docetaxel plus vandetanib versus docetaxel plus placebo in platinum-pretreated metastatic urothelial cancer. J Clin Oncol. 2012;30(5):507–512.
   PubMed Web of Science ®Google Scholar
• Bellmunt J, De Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376:1015–1026.
   PubMed Web of Science ®Google Scholar
• Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017;18(3):312–322.
   PubMed Web of Science ®Google Scholar
• Apolo AB, Infante JR, Balmanoukian A, et al. Avelumab, an anti-programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol. 2017;35(19):2117–2124.
   PubMed Web of Science ®Google Scholar
• Powles T, O’Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study. JAMA Oncol. 2017;3(9):e172411.
   PubMed Web of Science ®Google Scholar
• Powles T, Durán I, van der Heijden MS, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748–757.
   Google Scholar
• Balar AV, Galsky MD, Rosenberg JE, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76.
   Google Scholar
• O’Donnell PH, Grivas P, Balar AV, et al. Biomarker findings and mature clinical results from KEYNOTE-052: first-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC). J Clin Oncol 2017;35:suppl; abstr 4502.
   Web of Science ®Google Scholar
• EMD Serono Inc. and Pfizer Inc. Bavencio (avelumab) injection: US prescribing information. 2017 [cited 2017 Sept 3]. Available from: http://www.fda.gov.
   Google Scholar
• Rozali EN, Hato SV, Robinson BW, et al. Programmed death ligand 2 in cancer-induced immune suppression. Clin Dev Immunol. 2012;2012:1–8.
   Google Scholar
• Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. Expert Opin Biol Ther. 2017;17(4):515–523.
   PubMed Web of Science ®Google Scholar
• Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res. 2015;3(10):1148–1157.
   PubMed Web of Science ®Google Scholar
• Heery CR, O’Sullivan-Coyne GH, Marte JL, et al. Pharmacokinetic profile and receptor occupancy of avelumab (MSB0010718C), an anti-PD-L1 monoclonal antibody, in a phase I, open-label, dose escalation trial in patients with advanced solid tumors. J Clin Oncol. 2015;33S:abstract 3055.
   Google Scholar
• Heery CR, O’Sullivan-Coyne G, Madan RA, et al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017;18(5):587–598.
   PubMed Web of Science ®Google Scholar
• Avelumab (MSB0010718C) investigator’s Brochure version 7. Darmstadt (Germany): Merck KGaA; 2017.
   Google Scholar
• Apolo AB, Ellerton J, Infante JR, et al. Avelumab treatment of metastatic urothelial carcinoma (mUC) in the phase 1b JAVELIN solid Tumor study: updated analysis with ≥6 months of follow-up in all patients. Ann Oncol. 2017;28(suppl_5):v295–v329 (abstract 856P).
   Google Scholar
• Bracci L, Schiavoni G, Sistigu A, et al. Immune-based mechanisms of cytotoxic chemotherapy: implications for the design of novel and rationale-based combined treatments against cancer. Cell Death Differ. 2014;21(1):15–25.
   PubMed Web of Science ®Google Scholar
• Kelly K, Infante JR, Taylor MH, et al. Safety profile of avelumab in patients with advanced solid tumors: a JAVELIN pooled analysis of phase 1 and 2 data. J Clin Oncol. 2017 May;15_suppl:3059–3059.
   Google Scholar
• Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. N Engl J Med. 2017;377(20):1919–1929.
   PubMed Web of Science ®Google Scholar