Avelumab: clinical trial innovation and collaboration to advance anti-PD-L1 immunotherapy

Annals of Oncology

Volumn 28, Issue 7, 2017, Pages 1658-1666

  Chin, K ^a   Chand, V K ^a   Nuyten, D S A ^b  

^a EMD Serono Research and Development Institute Inc   (United States)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AVELUMAB; CD274 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; PROGRAMMED DEATH 1 LIGAND 1;

ANTAGONISTS AND INHIBITORS; DOSE RESPONSE; HUMAN; IMMUNOLOGY; NEOPLASM; PHASE 1 CLINICAL TRIAL (TOPIC);

ANTIBODIES, MONOCLONAL; B7-H1 ANTIGEN; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; NEOPLASMS;

EID: 85038613485     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdx170     Document Type: Article

References (50)

1. Dunn, G.P., Bruce, A.T., Ikeda, H., et al. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol 3:11 (2002), 991–998.
2. Schreiber, R.D., Old, L.J., Smyth, MJ., Cancer immunoediting: integrating immunity's roles in cancer suppression and promotion. Science 331:6024 (2011), 1565–1570.
3. Hanahan, D., Weinberg, RA., Hallmarks of cancer: the next generation. Cell 144:5 (2011), 646–674.
4. Pardoll, DM., The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 12:4 (2012), 252–264.
5. Dong, H., Strome, S.E., Salomao, D.R., et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 8:8 (2002), 793–800.
6. Iwai, Y., Ishida, M., Tanaka, Y., et al. 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 99:19 (2002), 12293–12297.
7. Latchman, Y.E., Liang, S.C., Wu, Y., et al. PD-L1-deficient mice show that PD-L1 on T cells, antigen-presenting cells, and host tissues negatively regulates T cells. Proc Natl Acad Sci U S A 101:29 (2004), 10691–10696.
8. Freeman, G.J., Long, A.J., Iwai, Y., et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 192:7 (2000), 1027–1034.
9. Butte, M.J., Keir, M.E., Phamduy, T.B., et al. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity 27:1 (2007), 111–122.
10. Keir, M.E., Freeman, G.J., Sharpe, AH., PD-1 regulates self-reactive CD8+ T cell responses to antigen in lymph nodes and tissues. J Immunol 179:8 (2007), 5064–5070.
11. Latchman, Y., Wood, C.R., Chernova, T., et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol 2:3 (2001), 261–268.
12. Rozali, E.N., Hato, S.V., Robinson, B.W., et al. Programmed death ligand 2 in cancer-induced immune suppression. Clin Dev Immunol, 2012, 2012, 656340.
13. Topalian, S.L., Drake, C.G., Pardoll, DM., Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol 24:2 (2012), 207–212.
14. Postow, M.A., Callahan, M.K., Wolchok, JD., Immune checkpoint blockade in cancer therapy. J Clin Oncol 33:17 (2015), 1974–1982.
15. Heery, C.R., O'Sullivan-Coyne, G., Madan, R.A., 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.
16. 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 3:10 (2015), 1148–1157.
17. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/results?term=avelumab&Search=Search. Updated 2016 (20 December 2016, date last accessed).
18. Gulley, J.L., Rajan, A., Spigel, D.R., et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol, 2017.
19. Apolo, A.B., Infante, J.R., Balmanoukian, A., et al. Avelumab, an anti-programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter phase 1b study. J Clin Oncol, 2017.
20. Chung, H.C., Arkenau, H.T., Wyrwicz, L., et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from JAVELIN Solid Tumor phase 1b trial: analysis of safety and clinical activity. J Clin Oncol, 34(Suppl 15), 2016.
21. Disis, M.L., Patel, M., Pant, S., et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian cancer from the JAVELIN Solid Tumor phase 1b trial: safety and clinical activity. J Clin Oncol, 34(Suppl 15), 2016.
22. Dirix, L.Y., Takacs, I., Nikolinakos, P., et al. Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase lb JAVELIN Solid Tumor trial. Cancer Res, 76(4), 2016.
23. Hassan, R., Thomas, A., Patel, M., et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN solid tumor phase 1b trial: safety, clinical activity, and PD-L1 expression. J Clin Oncol, 34(15), 2016.
24. Kaufman, H.L., Russell, J., Hamid, O., et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol 17:10 (2016), 1374–1385.
25. Bavencio (avelumab) [package insert]. Darmstadt, Germany; Merck KGaA; March, 2017.
26. Grenga, I., Donahue, R.N., Lepone, L.M., et al. A fully human IgG1 anti-PD-L1 MAb in an in vitro assay enhances antigen-specific T-cell responses. Clin Transl Immunol, 5(5), 2016, e83.
27. Brown, J.A., Dorfman, D.M., Ma, F.R., et al. Blockade of programmed death-1 ligands on dendritic cells enhances T cell activation and cytokine production. J Immunol 170:3 (2003), 1257–1266.
28. Fujii, R., Friedman, E.R., Richards, J., et al. Enhanced killing of chordoma cells by antibody-dependent cell-mediated cytotoxicity employing the novel anti-PD-L1 antibody avelumab. Oncotarget 7:23 (2016), 33498–33511.
29. Weiner, L.M., Surana, R., Wang, S., Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nat Rev Immunol 10:5 (2010), 317–327.
30. Herbst, R.S., Soria, J.C., Kowanetz, M., et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515:7528 (2014), 563–567.
31. Khleif, S.N., Lutsky, J., Segal, N., et al. MEDI4736, an anti-PD-L1 antibody with modified Fc domain: preclinical evaluation and early clinical results from a phase 1 study in patients with advanced solid tumors. Eur J Cancer, 49(2), 2013.
32. Gettinger, S., Herbst, RS., B7-H1/PD-1 blockade therapy in non-small cell lung cancer: current status and future direction. Cancer J 20:4 (2014), 281–289.
33. Donahue, R.N., Lepone, L.M., Grenga, I., et al. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer, 5, 2017, 20.
34. Shitara, K., Yamada, Y., Yoh, K., et al. Phase I, open-label, multi-ascending dose trial of avelumab (MSB0010718C), an anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors. J Clin Oncol, 33, 2015.
35. Agelli, M., Clegg, LX., Epidemiology of primary Merkel cell carcinoma in the United States. J Am Acad Dermatol 49:5 (2003), 832–841.
36. Goh, G., Walradt, T., Markarov, V., et al. Mutational landscape of MCPyV-positive and MCPyV-negative Merkel cell carcinomas with implications for immunotherapy. Oncotarget 7:3 (2016), 3403–3415.
37. Feng, H., Shuda, M., Chang, Y., Moore, PS., Clonal integration of a polyomavirus in human Merkel cell carcinoma. Science 319:5866 (2008), 1096–1100.
38. Lipson, E.J., Vincent, J.G., Loyo, M., et al. PD-L1 expression in the Merkel cell carcinoma microenvironment: association with inflammation, Merkel cell polyomavirus and overall survival. Cancer Immunol Res 1:1 (2013), 54–63.
39. Lemos, B.D., Storer, B.E., Iyer, J.G., et al. 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 63:5 (2010), 751–761.
40. Santamaria-Barria, J.A., Boland, G.M., Yeap, B.Y., et al. Merkel cell carcinoma: 30-year experience from a single institution. Ann Surg Oncol 20:4 (2013), 1365–1373.
41. Grabowski, J., Saltzstein, S.L., Sadler, G.R., et al. A comparison of Merkel cell carcinoma and melanoma: results from the California Cancer Registry. Clin Med Oncol 2 (2008), 327–333.
42. NCCN Clinical Practice Guidelines in Oncology. Merkel Cell Carcinoma. V1.2017.
43. Lebbe, C., Becker, J.C., Grob, J.J., et al. Diagnosis and treatment of Merkel cell carcinoma. European consensus-based interdisciplinary guideline. Eur J Cancer 51:16 (2015), 2396–2403.
44. Iyer, J.G., Blom, A., Doumani, R., et al. Response rates and durability of chemotherapy among 62 patients with metastatic Merkel cell carcinoma. Cancer Med 5:9 (2016), 2294–2301.
45. Mullard, A., Reining in the supersized phase I cancer trial. Nat Rev Drug Discov, 15(7), 2016, 516.
46. Kelly, K., Heery, C.R., Patel, M.R., et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer: Safety data from 1300 patients enrolled in the phase 1b JAVELIN Solid Tumor trial. J Clin Oncol, 34(15), 2016.
47. Eisenhauer, E.A., Therasse, P., Bogaerts, J., et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:2 (2009), 228–247.
48. Wolchok, J.D., Hoos, A., O'Day, S., et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 15:23 (2009), 7412–7420.
49. Weber, J.S., Yang, J.C., Atkins, M.B., Disis, ML., Toxicities of immunotherapy for the practitioner. J Clin Oncol. 33:18 (2015), 2092–2099.
50. Spain, L., Diem, S., Larkin, J., Management of toxicities of immune checkpoint inhibitors. Cancer Treat Rev 44 (2016), 51–60.