Atezolizumab, an anti-programmed death-ligand 1 antibody, in metastatic renal cell carcinoma: Long-term safety, clinical activity, and immune correlates from a phase Ia study

Journal of Clinical Oncology

Volumn 34, Issue 8, 2016, Pages 833-842

  McDermott, David F ^a   Sosman, Jeffrey A ^b   Sznol, Mario ^d   Massard, Christophe ^e   Gordon, Michael S ^f   Hamid, Omid ^g   Powderly, John D ⁱ   Infante, Jeffrey R ^c   Fassò, Marcella ^h   Wang, Yan V ^h   Zou, Wei ^h   Hegde, Priti S ^h   Fine, Gregg D ^h   Powles, Thomas ^j  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

^d YALE CANCER CENTER   (United States)

^e INSTITUT GUSTAVE ROUSSY   (France)

^f Pinnacle Oncology Hematology   (United States)

^g Angeles Clinic and Research Institute   (United States)

^h GENENTECH INC   (United States)

ⁱ Carolina BioOncology Institute   (United States)

^j QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE PHASE PROTEIN; ATEZOLIZUMAB; BEVACIZUMAB; BIOLOGICAL MARKER; INTERLEUKIN 2; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; PROGRAMMED DEATH 1 LIGAND 1; PROTEIN TYROSINE KINASE INHIBITOR; CD274 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; TUMOR MARKER;

ADULT; AGED; ANEMIA; APHTHOUS STOMATITIS; ARTHRALGIA; ARTICLE; ASSAY; ASTHENIA; ATAXIA; BACKACHE; CANCER STAGING; CHILL; CONSTIPATION; COUGHING; DECREASED APPETITE; DEHYDRATION; DERMATITIS; DIARRHEA; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSPEPSIA; DYSPNEA; ERYTHEMA; FATIGUE; FEMALE; FEVER; GAZE PARALYSIS; GENE EXPRESSION; HEADACHE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPOPHOSPHATEMIA; HYPOTHYROIDISM; IMMUNOCOMPETENT CELL; INFLUENZA; INSOMNIA; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE SPASM; MYALGIA; NAUSEA; NIGHT SWEAT; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PLASMA; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PRURITUS; RASH; REGULATORY T LYMPHOCYTE; STAINING; STOMATITIS; SUICIDE ATTEMPT; T LYMPHOCYTE; TUMOR CELL; VOMITING; XEROSTOMIA; CARCINOMA, RENAL CELL; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECTS; IMMUNOHISTOCHEMISTRY; IMMUNOLOGY; KIDNEY NEOPLASMS; MIDDLE AGED; TUMOR ASSOCIATED LEUKOCYTE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIGENS, CD274; BIOMARKERS, TUMOR; CARCINOMA, RENAL CELL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; KIDNEY NEOPLASMS; LYMPHOCYTES, TUMOR-INFILTRATING; MALE; MIDDLE AGED; T-LYMPHOCYTES;

EID: 84962497081     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.63.7421     Document Type: Article

References (53)

1. Bracarda S, Ravad A: Current and future treatment options for metastatic renal cell carcinoma. Eur Urol 8:799-808, 2009
2. Motzer RJ, Agarwal N, Beard C, et al: National Comprehensive Cancer Network: Kidney cancer. J Natl Compr Canc Netw 9:960-977, 2011
3. Motzer RJ, Escudier B, Oudard S, et al: RECORD-1 Study Group: Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial. Lancet 372:449-456, 2008
4. Motzer RJ, Barrios CH, Kim TM, et al: Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus firstline sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol 32:2765-2772, 2014
5. Yang JC, Childs R: Immunotherapy for renal cell cancer. J Clin Oncol 24:5576-5583, 2006
6. Itsumi M, Tatsugami K: Immunotherapy for renal cell carcinoma. Clin Dev Immunol 2010:284581, 2010
7. Chen DS, Mellman I: Oncology meets immunology: The cancer-immunity cycle. Immunity 39:1-10, 2013
8. Chen DS, Irving BA, Hodi FS: Molecular pathways: Next-generation immunotherapy-Inhibiting programmed death-ligand 1 and programmed death-1. Clin Cancer Res 18:6580-6587, 2012
9. Herbst RS, Soria JC, Kowanetz M, et al: Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515:563-567, 2014
10. Thompson RH, Dong H, Kwon ED: Implications of B7-H1 expression in clear cell carcinoma of the kidney for prognostication and therapy. Clin Cancer Res 13:709s-715s, 2007
11. Thompson RH, Dong H, Lohse CM, et al: PD-1 is expressed by tumor-infiltrating immune cells and is associated with poor outcome for patients with renal cell carcinoma. Clin Cancer Res 13:1757-1761, 2007
12. Thompson RH, Gillett MD, Cheville JC, et al: Costimulatory molecule B7-H1 in primary and metastatic clear cell renal cell carcinoma. Cancer 104:2084-2091, 2005
13. Thompson RH, Kuntz SM, Leibovich BC, et al: Tumor B7-H1 is associated with poor prognosis in renal cell carcinoma patients with long-term followup. Cancer Res 66:3381-3385, 2006
14. Thompson RH, Webster WS, Cheville JC, et al: B7-H1 glycoprotein blockade: A novel strategy to enhance immunotherapy in patients with renal cell carcinoma. Urology 66:10-14, 2005 (suppl)
15. Gunturi A, McDermott DF: Potential of new therapies like anti-PD1 in kidney cancer. Curr Treat Options Oncol 15:137-146, 2014
16. McDermott DF, Atkins MB: PD-1 as a potential target in cancer therapy. Cancer Med 2:662-673, 2013
17. McDermott DF, Drake CG, Sternberg CN: Immune checkpoint inhibitors in kidney cancer. Cancer J 19:348-352, 2014
18. Motzer RJ, Rini BI, McDermott DF, et al: Nivolumab for metastatic renal cell carcinoma: Results of a randomized phase II trial. J Clin Oncol 33:1430-1437, 2015
19. McDermott DF, Drake CG, Sznol M, et al: Survival, durable response, and long-term safety in patients with previously treated advanced renal cell carcinoma receiving nivolumab. J Clin Oncol 33:2013-2020, 2015
20. Powles T, Eder JP, Fine GD, et al: MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature 515:558-562, 2014
21. Spira A, Keunchi P, Mazieres J, et al: Efficacy, safety and predictive biomarker results from a randomized phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR). J Clin Oncol 33, 2015 (suppl; abstr 8010)
22. US Department of Health and Human Services: National Institutes of Health, National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf
23. Wolchok JD, 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 15:7412-7420, 2009
24. Eisenhauer EA, Therasse P, Bogaerts J, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247, 2009
25. Motzer RJ, Mazumdar M, Bacik J, et al: Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol 17:2530-2540, 1999
26. Jacobsen J, Grankvist K, Rasmuson T, et al: Expression of vascular endothelial growth factor protein in human renal cell carcinoma. BJU Int 93:297-302, 2004
27. Xu CF, Bing NX, Ball HA, et al: Pazopanib efficacy in renal cell carcinoma: Evidence for predictive genetic markers in angiogenesis-related and exposurerelated genes. J Clin Oncol 29:2557-2564, 2011
28. Jain S, Gautam V, Naseem S: Acute-phase proteins: As diagnostic tool. J Pharm Bioallied Sci 3:118-127, 2011
29. Kimura M, Tomita Y, Imai T, et al: Significance of serum amyloid A on the prognosis in patients with renal cell carcinoma. Cancer 92:2072-2075, 2001
30. Ji RR, Chasalow SD, Wang L, et al: An immune-active tumor microenvironment favors clinical response to ipilimumab. Cancer Immunol Immunother 61:1019-1031, 2012
31. Tumeh PC, Harview CL, Yearley JH, et al: PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 515:568-571, 2014
32. Ulloa-Montoya F, Louahed J, Dizier B, et al: Predictive gene signature in MAGE-A3 antigenspecific cancer immunotherapy. J Clin Oncol 31:2388-2395, 2013
33. Cruz-Guilloty F, Pipkin ME, Djuretic IM, et al: Runx3 and T-box proteins cooperate to establish the transcriptional program of effector CTLs. J Exp Med 206:51-59, 2009
34. de Goër de Herve MG, Jaafoura S, Vallée M, et al: FoxP3? regulatory CD4 T cells control the generation of functional CD8 memory. Nat Commun 3:986, 2012
35. Choueiri TK, Figueroa DJ, Fay AP, et al: Correlation of PD-L1 tumor expression and treatment outcomes in patients with renal cell carcinoma receiving sunitinib or pazopanib: results from COM-PARZ, a randomized controlled trial. Clin Cancer Res 21:1071-1077, 2015
36. Callea M, Albiges L, Gupta M, et al: Differential expression of PD-L1 between primary and metastatic sites in clear cell renal cell carcinoma. Cancer Immunol Res 3:1158-1164, 2015
37. Golshayan AR, George S, Heng DY, et al: Metastatic sarcomatoid renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy. J Clin Oncol 27:235-241, 2009
38. Leibovich BC, Han KR, Bui MH, et al: Scoring algorithm to predict survival after nephrectomy and immunotherapy in patients with metastatic renal cell carcinoma: A stratification tool for prospective clinical trials. Cancer 98:2566-2575, 2003
39. Patard JJ, Rioux-Leclercq N, Masson D, et al: Absence of VHL gene alteration and high VEGF expression are associated with tumour aggressiveness and poor survival of renal-cell carcinoma. Br J Cancer 101:1417-1424, 2009
40. Hegde PS, Jubb AM, Chen D, et al: Predictive impact of circulating vascular endothelial growth factor in four phase III trials evaluating bevacizumab. Clin Cancer Res 19:929-937, 2013
41. Sumimoto H, Imabayashi F, Iwata T, et al: The BRAF-MAPK signaling pathway is essential for cancer-immune evasion in human melanoma cells. J Exp Med 203:1651-1656, 2006
42. Curiel TJ, Coukos G, Zou L, et al: Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat Med 10:942-949, 2004
43. Manning EA, Ullman JG, Leatherman JM, et al: A vascular endothelial growth factor receptor-2 inhibitor enhances antitumor immunity through an immune-based mechanism. Clin Cancer Res 13:3951-3959, 2007
44. Shrimali RK, Yu Z, Theoret MR, et al: Antiangiogenic agents can increase lymphocyte infiltration into tumor and enhance the effectiveness of adoptive immunotherapy of cancer. Cancer Res 70:6171-6180, 2010
45. Kusmartsev S, Eruslanov E, Kübler H, et al: Oxidative stress regulates expression of VEGFR1 in myeloid cells: Link to tumor-induced immune suppression in renal cell carcinoma. J Immunol 181:346-353, 2008
46. Roland CL, Lynn KD, Toombs JE, et al: Cytokine levels correlate with immune cell infiltration after anti-VEGF therapy in preclinical mouse models of breast cancer. PLoS One 4:e7669, 2009
47. Gabrilovich DI, Ishida T, Nadaf S, et al: Antibodies to vascular endothelial growth factor enhance the efficacy of cancer immunotherapy by improving endogenous dendritic cell function. Clin Cancer Res 5:2963-2970, 1999
48. Liu X, Hoang A, Zhou L, et al: Resistance to anti-angiogenic therapy is associated with an immunosuppressive tumor microenvironment in metastatic renal cell carcinoma. Cancer Immunol Res 11:856-861, 2015
49. Facciabene A, Motz GT, Coukos G: T-regulatory cells: Key players in tumor immune escape and angiogenesis. Cancer Res 72:2162-2171, 2012
50. Terme M, Pernot S, Marcheteau E, et al: VEGFA-VEGFR pathway blockade inhibits tumorinduced regulatory T-cell proliferation in colorectal cancer. Cancer Res 73:539-549, 2013
51. Lieu C, Bendell J, Powderly JD, et al: Safety and efficacy of MPDL3280A (anti-PDL1) in combination with bevacizumab (bev) and/or chemotherapy (chemo) in patients with locally advanced or metastatic solid tumors. Ann Oncol 25: iv361-iv372, 2014 (suppl 4; abstr 1049o)
52. Sznol M, McDermott DF, Jones SF, et al: Phase Ib evaluation of MPDL3280A (anti-PDL1) in combination with bevacizumab (bev) in patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol 33, 2015 (suppl; abstr 410)
53. Choueiri TK, Fishman MN, Escudier B, et al: Immunomodulatory activity of nivolumab in metastatic renal cell carcinoma (mRCC): Association of biomarkers with clinical outcomes. J Clin Oncol 33, 2015 (suppl; abstr 4500)