PD-1/PD-L1 pathway inhibitors in advanced prostate cancer

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018;68:7–30.
   PubMed Web of Science ®Google Scholar
• Cooperberg MR, Carroll PR. Trends in management for patients with localized prostate cancer, 1990–2013. JAMA. 2015;314:80–82.
   PubMed Web of Science ®Google Scholar
• Sweeney CJ, Chen Y-H, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373:737–746.
   PubMed Web of Science ®Google Scholar
• James ND, Sydes MR, Clarke NW, et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016;387:1163–1177.
   PubMed Web of Science ®Google Scholar
• Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017;377:352–360.
   PubMed Web of Science ®Google Scholar
• James ND, De Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377:338–351.
   PubMed Web of Science ®Google Scholar
• Tannock, I. F., et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502–1512.
   PubMed Web of Science ®Google Scholar
• Kantoff, P. W., et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411–422.
   PubMed Web of Science ®Google Scholar
• de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet Lond Engl. 2010;376:1147–1154.
   PubMed Web of Science ®Google Scholar
• de Bono, J. S., et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995–2005.
   PubMed Web of Science ®Google Scholar
• Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187–1197.
   PubMed Web of Science ®Google Scholar
• Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213–223.
   PubMed Web of Science ®Google Scholar
• Oudard, S., et al. Cabazitaxel versus docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: a randomized phase III trial-FIRSTANA. J Clin Oncol Off J Am Soc Clin Oncol. 2017;JCO2016721068. DOI:10.1200/JCO.2016.72.1068.
   Google Scholar
• McIntyre BW, Allison JP. The mouse T cell receptor: structural heterogeneity of molecules of normal T cells defined by Xenoantiserum. Cell. 1983;34:739–746.
   PubMed Web of Science ®Google Scholar
• Harding FA, McArthur JG, Gross JA, et al. CD28-mediated signalling co-stimulates murine T cells and prevents induction of anergy in T-cell clones. Nature. 1992;356:607–609.
   PubMed Web of Science ®Google Scholar
• Ribas A. Releasing the brakes on cancer immunotherapy. N Engl J Med. 2015;373:1490–1492.
   PubMed Web of Science ®Google Scholar
• Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med. 1995;182:459–465.
   PubMed Web of Science ®Google Scholar
• Hodi, F. S., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723.
   PubMed Web of Science ®Google Scholar
• Tumeh PC, Harview CL, Yearley JH, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014;515:568–571.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, Kluger H, Callahan MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013;369:122–133.
   PubMed Web of Science ®Google Scholar
• Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372:320–330.
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373:123–135.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627–1639.
   PubMed Web of Science ®Google Scholar
• Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016;17:1590–1598.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373:1803–1813.
   PubMed Web of Science ®Google Scholar
• Ferris RL, Blumenschein G, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375:1856–1867.
   PubMed Web of Science ®Google Scholar
• 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 COMPARZ, a randomized controlled trial. Clin Cancer Res Off J Am Assoc Cancer Res. 2015;21:1071–1077.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375:1823–1833.
   PubMed Web of Science ®Google Scholar
• Patel SP, Kurzrock R. PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther. 2015;14:847–856.
   PubMed Web of Science ®Google Scholar
• Topalian, S. L., et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366:2443–2454.
   PubMed Web of Science ®Google Scholar
• Martin AM, Nirschl TR, Nirschl CJ, et al. Paucity of PD-L1 expression in prostate cancer: innate and adaptive immune resistance. Prostate Cancer Prostatic Dis. 2015;18:325–332.
   PubMed Web of Science ®Google Scholar
• Baas W, Gershburg S, Dynda D, et al. Immune characterization of the programmed death receptor pathway in high risk prostate cancer. Clin Genitourin Cancer. 2017;15:577–581.
   PubMed Web of Science ®Google Scholar
• Gevensleben H, Dietrich D, Golletz C, et al. The immune checkpoint regulator PD-L1 is highly expressed in aggressive primary prostate cancer. Clin Cancer Res Off J Am Assoc Cancer Res. 2016;22:1969–1977.
   PubMed Web of Science ®Google Scholar
• Bishop, J. L., et al. PD-L1 is highly expressed in enzalutamide resistant prostate cancer. Oncotarget. 2014;6:234–242.
   Web of Science ®Google Scholar
• Graff, J. N., et al. First evidence of significant clinical activity of PD-1 inhibitors in metastatic, castration resistant prostate cancer (mCRPC). Ann Oncol. 2016; 27.
   PubMedGoogle Scholar
• Gubin MM, Schreiber RD. CANCER. The odds of immunotherapy success. Science. 2015;350:158–159.
   PubMed Web of Science ®Google Scholar
• Snyder, A., et al. Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med. 2014;371:2189–2199.
   PubMed Web of Science ®Google Scholar
• Rizvi, N. A., et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015;348:124–128.
   PubMed Web of Science ®Google Scholar
• Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357:409–413.
   PubMed Web of Science ®Google Scholar
• Yarchoan M, Hopkins A, Jaffee EM. Tumor mutational burden and response rate to PD-1 inhibition. N Engl J Med. 2017;377:2500–2501.
   PubMed Web of Science ®Google Scholar
• Alexandrov LB, Nik-Zainal S, Wedge DC, et al. Signatures of mutational processes in human cancer. Nature. 2013;500:415–421.
   PubMed Web of Science ®Google Scholar
• Vogelstein B, Papadopoulos N, Velculescu VE, et al. Cancer genome landscapes. Science. 2013;339:1546–1558.
   PubMed Web of Science ®Google Scholar
• Robinson D, Van Allen E, Wu Y-M, et al. Integrative clinical genomics of advanced prostate cancer. Cell. 2015;161:1215–1228.
   PubMed Web of Science ®Google Scholar
• Pritchard CC, Mateo J, Walsh MF, et al. Inherited DNA-repair gene mutations in men with metastatic prostate cancer. N Engl J Med. 2016;375:443–453.
   PubMed Web of Science ®Google Scholar
• Strickland KC, Howitt BE, Shukla SA, et al. Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer. Oncotarget. 2016;7:13587–13598.
   PubMed Web of Science ®Google Scholar
• Cancer Genome Atlas Research Network. Integrated genomic characterization of endometrial carcinoma. Nature. 2013;497:67.
   PubMed Web of Science ®Google Scholar
• Pritchard, C. C., et al. Complex MSH2 and MSH6 mutations in hypermutated microsatellite unstable advanced prostate cancer. Nat Commun. 2014 Sep 25;5:4988.
   Web of Science ®Google Scholar
• Brinker DA, Potter SR, Epstein JI. Ductal adenocarcinoma of the prostate diagnosed on needle biopsy: correlation with clinical and radical prostatectomy findings and progression. Am J Surg Pathol. 1999;23:1471–1479.
   PubMed Web of Science ®Google Scholar
• Schweizer MT, Cheng HH, Tretiakova MS, et al. Mismatch repair deficiency may be common in ductal adenocarcinoma of the prostate. Oncotarget. 2016;7:82504–82510.
   PubMed Web of Science ®Google Scholar
• Guedes, L. B., et al. MSH2 loss in primary prostate cancer. Clin Cancer Res Off J Am Assoc Cancer Res. 2017;23:6863–6874.
   PubMed Web of Science ®Google Scholar
• Research, C. for D. E. and. Approved Drugs. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. Accessed on February 10, 2018. Available at: https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm560040.htm.
   Google Scholar
• Small EJ, Tchekmedyian NS, Rini BI, et al. A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res Off J Am Assoc Cancer Res. 2007;13:1810–1815.
   PubMed Web of Science ®Google Scholar
• Tollefson, M., et al. A randomized phase II study of ipilimumab with androgen ablation compared with androgen ablation alone in patients with advanced prostate cancer. J Urol. 2010;183:e261.
   Web of Science ®Google Scholar
• Slovin SF, Higano CS, Hamid O, et al. Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study. Ann Oncol Off J Eur Soc Med Oncol. 2013;24:1813–1821.
   PubMed Web of Science ®Google Scholar
• Massari F, Ciccarese C, Caliò A, et al. Magnitude of PD-1, PD-L1 and T lymphocyte expression on tissue from castration-resistant prostate adenocarcinoma: an exploratory analysis. Target Oncol. 2016;11:345–351.
   PubMed Web of Science ®Google Scholar
• Calagua C, Russo J, Sun Y, et al. Expression of PD-L1 in hormone-naïve and treated prostate cancer patients receiving neoadjuvant abiraterone acetate plus prednisone and leuprolide. Clin Cancer Res Off J Am Assoc Cancer Res. 2017;23:6812–6822.
   PubMed Web of Science ®Google Scholar
• Ness N, Andersen S, Khanehkenari MR, et al. The prognostic role of immune checkpoint markers programmed cell death protein 1 (PD-1) and programmed death ligand 1 (PD-L1) in a large, multicenter prostate cancer cohort. Oncotarget. 2017;8:26789–26801.
   PubMedGoogle Scholar
• Kwon, E. D., et al. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014;15:700–712.
   PubMed Web of Science ®Google Scholar
• Beer TM, Kwon ED, Drake CG, et al. Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2017;35:40–47.
   PubMed Web of Science ®Google Scholar
• Graff JN, Alumkal JJ, Drake CG, et al. Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer. Oncotarget. 2016;7. DOI:10.18632/oncotarget.10547.
   Google Scholar
• Hansen, A., et al. Pembrolizumab for patients with advanced prostate adenocarcinoma: preliminary results from the KEYNOTE-028 study. Ann Oncol. 2016;27(6):243–265.
   Web of Science ®Google Scholar
• Boudadi, K., et al. Phase 2 biomarker-driven study of ipilimumab plus nivolumab (Ipi/Nivo) for ARV7-positive metastatic castrate-resistant prostate cancer (mCRPC). J Clin Oncol. 2017;35(suppl; abstr 5035).
   Google Scholar
• Antonarakis, E. S., et al. AR-V7 and resistance to enzalutamide and abiraterone in prostate cancer. N Engl J Med. 2014;371:1028–1038.
   PubMed Web of Science ®Google Scholar
• Antonarakis ES, Lu C, Luber B, et al. Clinical significance of androgen receptor splice variant-7 mRNA detection in circulating tumor cells of men with metastatic castration-resistant prostate cancer treated with first- and second-line abiraterone and enzalutamide. J Clin Oncol Off J Am Soc Clin Oncol. 2017;35:2149–2156.
   PubMed Web of Science ®Google Scholar
• A phase I study of cabozantinib plus nivolumab (CaboNivo) and cabonivo plus ipilimumab (CaboNivoIpi) in patients (pts) with refractory metastatic (m) urothelial carcinoma (UC) and other genitourinary (GU) tumors. J Clin Oncol. 2017;35(suppl 6S; abstract 293). Available from: https://meetinglibrary.asco.org/record/152234/abstract.
   Google Scholar
• Rosenberg JE, Hoffman-Censits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016;387:1909–1920.
   PubMed Web of Science ®Google Scholar
• Fehrenbacher L, Spira A, Ballinger M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387:1837–1846.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017;389:255–265.
   PubMed Web of Science ®Google Scholar
• Kaufman HL, 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. 2016;17:1374–1385.
   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:e172411.
   PubMed Web of Science ®Google Scholar
• Fakhrejahani F, Madan RA, Dahut WL, et al. Avelumab in metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2017 Accessed 2017 Nov 18;35(suppl; abstr 5037). Available at https://meetinglibrary.asco.org/record/146059/poster.
   Google Scholar
• Meeting Library | Combination of PDL-1 and PARP inhibition in an unselected population with metastatic castrate-resistant prostate cancer (mCRPC). cited 2017 Dec 8. Available from: https://meetinglibrary.asco.org/record/146020/abstract.
   Google Scholar
• Wu C-T, Chen W-C, Chang Y-H, et al. The role of PD-L1 in the radiation response and clinical outcome for bladder cancer. Sci Rep. 2016;6:19740.
   PubMed Web of Science ®Google Scholar
• Han JJ, Kim D-W, Koh J, et al. Change in PD-L1 expression after acquiring resistance to Gefitinib in EGFR-mutant non-small-cell lung cancer. Clin Lung Cancer. 2016;17:263–270.e2.
   PubMed Web of Science ®Google Scholar
• Hecht M, Büttner-Herold M, Erlenbach-Wünsch K, et al. PD-L1 is upregulated by radiochemotherapy in rectal adenocarcinoma patients and associated with a favourable prognosis. Eur J Cancer Oxf Engl. 2016;65:52–60.
   PubMed Web of Science ®Google Scholar
• Sen, D. R., et al. The epigenetic landscape of T cell exhaustion. Science. 2016;354:1165–1169.
   PubMed Web of Science ®Google Scholar
• Ghoneim, H. E., et al. De Novo epigenetic programs inhibit PD-1 blockade-mediated T cell rejuvenation. Cell. 2017;170:142–157.e19.
   PubMed Web of Science ®Google Scholar
• Markowski MC, Marzo AMD, Antonarakis ES. BET inhibitors in metastatic prostate cancer: therapeutic implications and rational drug combinations. Expert Opin Investig Drugs. 2017;26:1391–1397.
   PubMed Web of Science ®Google Scholar
• Gevensleben H, Holmes EE, Goltz D, et al. PD-L1 promoter methylation is a prognostic biomarker for biochemical recurrence-free survival in prostate cancer patients following radical prostatectomy. Oncotarget. 2016;7:79943–79955.
   PubMedGoogle Scholar
• Goltz D, Gevensleben H, Dietrich J, et al. Promoter methylation of the immune checkpoint receptor PD-1 (PDCD1) is an independent prognostic biomarker for biochemical recurrence-free survival in prostate cancer patients following radical prostatectomy. OncoImmunology. 2016;5:e1221555.
   PubMed Web of Science ®Google Scholar