Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial

Agelli, 2003, Epidemiology of primary Merkel cell carcinoma in the United States, J Am Acad Dermatol, 49, 832, 10.1016/S0190-9622(03)02108-X Feng, 2008, Clonal integration of a polyomavirus in human Merkel cell carcinoma, Science, 319, 1096, 10.1126/science.1152586 Lebbé, 2015, Diagnosis and treatment of Merkel cell carcinoma. European consensus-based interdisciplinary guideline, Eur J Cancer, 51, 2396, 10.1016/j.ejca.2015.06.131 Fitzgerald, 2015, Dramatic increase in the incidence and mortality from Merkel cell carcinoma in the United States, Am Surg, 81, 802, 10.1177/000313481508100819 Youlden, 2014, Incidence and survival for Merkel cell carcinoma in Queensland, Australia, 1993–2010, JAMA Dermatol, 150, 864, 10.1001/jamadermatol.2014.124 Allen, 2005, Merkel cell carcinoma: prognosis and treatment of patients from a single institution, J Clin Oncol, 23, 2300, 10.1200/JCO.2005.02.329 Lemos, 2010, Pathologic nodal evaluation improves prognostic accuracy in Merkel cell carcinoma: analysis of 5823 cases as the basis of the first consensus staging system, J Am Acad Dermatol, 63, 751, 10.1016/j.jaad.2010.02.056 Tai, 2000, Chemotherapy in neuroendocrine/Merkel cell carcinoma of the skin: case series and review of 204 cases, J Clin Oncol, 18, 2493, 10.1200/JCO.2000.18.12.2493 Santamaria-Barria, 2013, Merkel cell carcinoma: 30-year experience from a single institution, Ann Surg Oncol, 20, 1365, 10.1245/s10434-012-2779-3 Voog, 1999, Chemotherapy for patients with locally advanced or metastatic Merkel cell carcinoma, Cancer, 85, 2589, 10.1002/(SICI)1097-0142(19990615)85:12<2589::AID-CNCR15>3.0.CO;2-F Iyer, 2016, Response rates and durability of chemotherapy among 62 patients with metastatic Merkel cell carcinoma, Cancer Med, 10.1002/cam4.815 Sharma, 1991, Chemotherapy of metastatic Merkel cell carcinoma: case report and review of the literature, Am J Clin Oncol, 14, 166, 10.1097/00000421-199104000-00014 Satpute, 2014, Role of platinum-based chemotherapy for Merkel cell tumor in adjuvant and metastatic settings, Proc Am Soc Clin, 32 Desch, 2013, Merkel cell carcinoma: chemotherapy and emerging new therapeutic options, J Skin Cancer, 2013, 327150, 10.1155/2013/327150 Santos-Juanes, 2015, Merkel cell carcinoma and Merkel cell polyomavirus: a systematic review and meta-analysis, Br J Dermatol, 173, 42, 10.1111/bjd.13870 Rodig, 2012, Improved detection suggests all Merkel cell carcinomas harbor Merkel polyomavirus, J Clin Invest, 122, 4645, 10.1172/JCI64116 Bhatia, 2011, Immunobiology of Merkel cell carcinoma: implications for immunotherapy of a polyomavirus-associated cancer, Curr Oncol Rep, 13, 488, 10.1007/s11912-011-0197-5 Wong, 2015, UV-associated mutations underlie the etiology of MCV-negative Merkel cell carcinomas, Cancer Res, 75, 5228, 10.1158/0008-5472.CAN-15-1877 Goh, 2016, Mutational landscape of MCPyV-positive and MCPyV-negative Merkel cell carcinomas with implications for immunotherapy, Oncotarget, 7, 3403, 10.18632/oncotarget.6494 Harms, 2015, The distinctive mutational spectra of polyomavirus-negative Merkel cell carcinoma, Cancer Res, 75, 3720, 10.1158/0008-5472.CAN-15-0702 Heath, 2008, Clinical characteristics of Merkel cell carcinoma at diagnosis in 195 patients: the AEIOU features, J Am Acad Dermatol, 58, 375, 10.1016/j.jaad.2007.11.020 Paulson, 2013, Systemic immune suppression predicts diminished Merkel cell carcinoma-specific survival independent of stage, J Invest Dermatol, 133, 642, 10.1038/jid.2012.388 Dong, 2002, Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion, Nat Med, 8, 793, 10.1038/nm0902-1039c Hirano, 2005, Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity, Cancer Res, 65, 1089, 10.1158/0008-5472.1089.65.3 Iwai, 2002, Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade, Proc Natl Acad Sci USA, 99, 12293, 10.1073/pnas.192461099 Patel, 2015, PD-L1 expression as a predictive biomarker in cancer immunotherapy, Mol Cancer Ther, 14, 847, 10.1158/1535-7163.MCT-14-0983 Aguiar, 2016, The role of PD-L1 expression as a predictive biomarker in advanced non-small-cell lung cancer: a network meta-analysis, Immunotherapy, 8, 479, 10.2217/imt-2015-0002 Lipson, 2013, PD-L1 expression in the Merkel cell carcinoma microenvironment: association with inflammation, Merkel cell polyomavirus and overall survival, Cancer Immunol Res, 1, 54, 10.1158/2326-6066.CIR-13-0034 Afanasiev, 2013, Merkel polyomavirus-specific T cells fluctuate with Merkel cell carcinoma burden and express therapeutically targetable PD-1 and Tim-3 exhaustion markers, Clin Cancer Res, 19, 5351, 10.1158/1078-0432.CCR-13-0035 Iyer, 2011, Merkel cell polyomavirus-specific CD8(+) and CD4(+) T-cell responses identified in Merkel cell carcinomas and blood, Clin Cancer Res, 17, 6671, 10.1158/1078-0432.CCR-11-1513 Nghiem, 2016, PD-1 blockade with pembrolizumab in advanced Merkel-cell carcinoma, N Engl J Med, 374, 2542, 10.1056/NEJMoa1603702 Heery, 2014, Phase I open-label, multiple ascending dose trial of MSB0010718C, an anti-PD-L1 monoclonal antibody, in advanced solid malignancies, Proc Am Soc Clin Oncol, 32 Boyerinas, 2015, Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on human tumor cells, Cancer Immunol Res, 3, 1148, 10.1158/2326-6066.CIR-15-0059 Heery, 2015, Pharmacokinetic profile and receptor occupancy of avelumab (MSB00110718C), an anti-PD-L1 monoclonal antibody, in a phase I, open-label, dose escalation trial in patients with advanced solid tumors, Proc Am Soc Clin Oncol, 33 Kelly, 2015, Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic or locally advanced solid tumors: assessment of safety and tolerability in a phase I, open-label expansion study, Proc Am Soc Clin Oncol, 33 Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Shuda, 2009, Human Merkel cell polyomavirus infection I. MCV T antigen expression in Merkel cell carcinoma, lymphoid tissues and lymphoid tumors, Int J Cancer, 125, 1243, 10.1002/ijc.24510 Wolchok, 2009, Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria, Clin Cancer Res, 15, 7412, 10.1158/1078-0432.CCR-09-1624 Jennison, 2000 Veness, 2005, Merkel cell carcinoma: improved outcome with adjuvant radiotherapy, ANZ J Surg, 75, 275, 10.1111/j.1445-2197.2005.03353.x Weber, 2015, Toxicities of immunotherapy for the practitioner, J Clin Oncol, 33, 2092, 10.1200/JCO.2014.60.0379