Pembrolizumab for the treatment of bladder cancer

References

• Noble F, Mellows T, McCormick Matthews LH, et al. Tumour infiltrating lymphocytes correlate with improved survival in patients with oesophageal adenocarcinoma. Cancer Immunol Immunother: CII. 2016;65(6):651–662.
   PubMed Web of Science ®Google Scholar
• Antoni S, Ferlay J, Soerjomataram I, et al. Bladder cancer incidence and mortality: a global overview and recent trends. Eur Urol. 2017;71(1):96–108.
   PubMed Web of Science ®Google Scholar
• Griffiths G, Hall R, Sylvester R, et al. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol: Official J Am Soc Clin Oncol. 2011;29(16):2171–2177.
   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: Official J Am Soc Clin Oncol. 2005;23(21):4602–4608.
   PubMed Web of Science ®Google Scholar
• Bellmunt J, Orsola A, Leow JJ, et al. Bladder cancer: ESMO practice guidelines for diagnosis, treatment and follow-up. Ann Oncol: Offi J Eur Soc Med Oncol. 2014;25(Suppl 3):iii40–48.
   PubMed Web of Science ®Google Scholar
• Loehrer PJ Sr., 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: Official J Am Soc Clin Oncol. 1992;10(7):1066–1073.
   PubMed Web of Science ®Google Scholar
• von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol: Official J Am Soc Clin Oncol. 2000;18(17):3068–3077.
   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: Official J Am Soc Clin Oncol. 2012;30(2):191–199.
   PubMed Web of Science ®Google Scholar
• Kim JW, Tomita Y, Trepel J, et al. Emerging immunotherapies for bladder cancer. Curr Opin Oncol. 2015;27(3):191–200.
   PubMed Web of Science ®Google Scholar
• Bellmunt J, Theodore 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: Official J Am Soc Clin Oncol. 2009;27(27):4454–4461.
   PubMed Web of Science ®Google Scholar
• Larkin J, Minor D, D’Angelo S, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator’s choice chemotherapy in checkmate 037: a randomized, controlled, open-label Phase III trial. J Clin Oncol: Official J Am Soc Clin Oncol. 2017;Jco2016718023.
   Google Scholar
• Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet (London, England). 2016;387(10027):1540–1550.
   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(19):1803–1813.
   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(17):1627–1639.
   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(11):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.
   Web of Science ®Google Scholar
• Ferris RL, Blumenschein G Jr., Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375(19):1856–1867.
   PubMed Web of Science ®Google Scholar
• FDA. Pembrolizumab (Keytruda): advanced or metastatic urothelial carcinoma. FDA, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm last accessed 2017 Nov 6
   Google Scholar
• FDA. Atezolizumab for urothelial carcinoma. FDA, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501878.htm last accessed 2017 Nov 6
   Google Scholar
• FDA. Nivolumab for treatment of urothelial carcinoma. FDA, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm last accessed 2017 Nov 6
   Google Scholar
• FDA. FDA grants accelerated approval to avelumab for urothelial carcinoma. FDA, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm last accessed 2017 Nov 6
   Google Scholar
• FDA. Durvalumab (Imfinzi). FDA, 2017. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559930.htm last accessed 2017 Nov 6
   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(11):1590–1598.
   PubMed Web of Science ®Google Scholar
• Plimack ER, Bellmunt J, Gupta S, et al. Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study. Lancet Oncol. 2017;18(2):212–220.
   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: Official J Am Soc Clin Oncol. 2017;35(19):2117–2124.
   PubMed Web of Science ®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 (London, England). 2016;387(10031):1909–1920.
   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. The Lancet. 2017.
   Google Scholar
• Center For Drug Evaluation and Research. Application number: 125514Orig1s000. Pharmacology Review: Pembrolizumab (Keytruda), 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000PharmR.pdf last accessed 2017 Nov 6
   Google Scholar
• Merck. Full prescribing information: pembrolizumab. Merck, 2017. Available at: http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf last accessed 2017 Nov 6.
   Google Scholar
• Longoria TC, Tewari KS. Evaluation of the pharmacokinetics and metabolism of pembrolizumab in the treatment of melanoma. Expert Opin Drug Metab Toxicol. 2016;12(10):1247–1253.
   PubMed Web of Science ®Google Scholar
• Keytruda. electronic Medicines Compendium, 2017. Available at: http://www.medicines.org.uk/emc/medicine/33162 last accessed 2017 Nov 6
   Google Scholar
• Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823–1833.
   PubMed Web of Science ®Google Scholar
• Chow LQ, Haddad R, Gupta S, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol: Official J Am Soc Clin Oncol. 2016.
   Google Scholar
• Seiwert TY, Burtness B, Mehra R, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol. 2016;17(7):956–965.
   PubMed Web of Science ®Google Scholar
• Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum- and cetuximab-refractory head and neck cancer: results from a single-arm, Phase II study. J Clin Oncol: Official J Am Soc Clin Oncol. 2017;35(14):1542–1549.
   PubMed Web of Science ®Google Scholar
• Freshwater T, Kondic A, Ahamadi M, et al. Evaluation of dosing strategy for pembrolizumab for oncology indications. J Immunother Cancer. 2017;5:43.
   PubMed Web of Science ®Google Scholar
• Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet (London, England). 2014;384(9948):1109–1117.
   PubMed Web of Science ®Google Scholar
• Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018–2028.
   PubMed Web of Science ®Google Scholar
• Nanda R, Chow LQ, Dees EC, et al. Pembrolizumab in patients with advanced triple-negative breast cancer: phase Ib KEYNOTE-012 study. J Clin Oncol: Official J Am Soc Clin Oncol. 2016;34(21):2460–2467.
   PubMed Web of Science ®Google Scholar
• Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013;369(2):134–144.
   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
• Petrylak DP, Powles T, Bellmunt J, et al. A phase Ia study of MPDL3280A (anti-PDL1): updated response and survival data in urothelial bladder cancer (UBC). J Clin Oncol. 2015;33(15_suppl):4501.
   Web of Science ®Google Scholar
• Powles T, Eder JP, Fine GD, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014;515(7528):558–562.
   PubMed Web of Science ®Google Scholar
• Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(11):1483–1492.
   PubMed Web of Science ®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 (London, England). 2017;389(10064):67–76.
   PubMed Web of Science ®Google Scholar
• EMA. Keytruda Pembrolizumab. EMA, 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003820/WC500231699.pdf last accessed on 2017 Nov 6
   Google Scholar
• EMA. Tecentriq atezolizumab. EMA, 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004143/WC500231701.pdf last accessed on 2017 Nov 6
   Google Scholar
• EMA. Opdivo nivolumab. EMA, 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003985/WC500226181.pdf last accessed on 2017 Nov 6
   Google Scholar
• Ferrara R. Hyperprogressive disease (HPD) is frequent in non-small cell lung cancer (NSCLC) patients (Pts) treated with anti PD1/PD-L1 agents (IO). In: IASLC 18th World Conference on Lung Cancer. (Yokohama, Japan, 2017)
   Google Scholar
• Champiat S, Dercle L, Ammari S, et al. Hyperprogressive disease is a new pattern of progression in cancer patients treated by anti-PD-1/PD-L1. Clin Cancer Res: an Officl J Amer Asso Cancer Res. 2017;23(8):1920–1928.
   PubMed Web of Science ®Google Scholar
• Matter-Walstra K, Schwenkglenks M, Aebi S, et al. A cost-effectiveness analysis of nivolumab versus docetaxel for advanced nonsquamous NSCLC Including PD-L1 Testing. J Thoracic Oncol: Official Publicat Internat Associat Study Lung Cancer. 2016;11(11):1846–1855.
   PubMed Web of Science ®Google Scholar
• Nivolumab for treating locally advanced unresectable or metastatic urothelial carcinoma after platinum-containing chemotherapy. NICE, 2017. Available at: https://www.nice.org.uk/guidance/GID-TA10163/documents/appraisal-consultation-document [ last accessed 6 November 2017].
   Google Scholar
• Garton AJ, Seibel S, Lopresti-Morrow L, et al. Anti-KIT monoclonal antibody treatment enhances the antitumor activity of immune checkpoint inhibitors by reversing tumor-induced immunosuppression. Mol Cancer Ther. 2017;16(4):671–680.
   PubMed Web of Science ®Google Scholar
• Herrera FG, Bourhis J, Coukos G. Radiotherapy combination opportunities leveraging immunity for the next oncology practice. CA Cancer J Clin. 2017;67(1):65–85.
   PubMed Web of Science ®Google Scholar
• Vacchelli E, Bloy N, Aranda F, et al. Trial Watch: immunotherapy plus radiation therapy for oncological indications. Oncoimmunology. 2016;5(9):e1214790.
   PubMed Web of Science ®Google Scholar
• De Wolf K, Kruse V, Sundahl N, et al. A phase II trial of stereotactic body radiotherapy with concurrent anti-PD1 treatment in metastatic melanoma: evaluation of clinical and immunologic response. J Transl Med. 2017;15(1):21.
   PubMedGoogle Scholar
• Sundahl N, De Wolf K, Rottey S, et al. A phase I/II trial of fixed-dose stereotactic body radiotherapy with sequential or concurrent pembrolizumab in metastatic urothelial carcinoma: evaluation of safety and clinical and immunologic response. J Transl Med. 2017;15(1):150.
   PubMedGoogle Scholar
• Powles T, Smith K, Stenzl A, et al. Immune checkpoint inhibition in metastatic urothelial cancer. Eur Urol. 2017;72(4):477–481.
   PubMed Web of Science ®Google Scholar