MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer

Choueiri, T. K. et al. Double-blind, randomized trial of docetaxel plus vandetanib versus docetaxel plus placebo in platinum-pretreated metastatic urothelial cancer. J. Clin. Oncol. 30, 507–512 (2012)

Bellmunt, J. 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. 27, 4454–4461 (2009)

Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature 507, 315–322 (2014)

Lawrence, M. S. et al. Mutational heterogeneity in cancer and the search for new cancer-associated genes. Nature 499, 214–218 (2013)

Kandoth, C. et al. Mutational landscape and significance across 12 major cancer types. Nature 502, 333–339 (2013)

Chen, D. S. & Mellman, I. Oncology meets immunology: the cancer-immunity cycle. Immunity 39, 1–10 (2013)

Chen, D. S., Irving, B. A. & Hodi, F. S. Molecular pathways: next-generation immunotherapy—inhibiting programmed death-ligand 1 and programmed death-1. Clin. Cancer Res. 18, 6580–6587 (2012)

van Rooij, N. et al. Tumor exome analysis reveals neoantigen-specific T-cell reactivity in an ipilimumab-responsive melanoma. J. Clin. Oncol. 31, e439–e442 (2013)

Herbst, R. S. et al. Predictive correlates of response to anti-PD-L1 in cancer patients. Nature http://dx.doi.org/10.1038/nature14011 (this issue)

Topalian, S. L. et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N. Engl. J. Med. 366, 2443–2454 (2012)

Bellmunt, J. et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J. Clin. Oncol. 28, 1850–1855 (2010)

Sonpavde, G. et al. Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials. Eur. Urol. 63, 717–723 (2013)

Wrammert, J. et al. Rapid cloning of high-affinity human monoclonal antibodies against influenza virus. Nature 453, 667–671 (2008)

De Santis, M. 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. 30, 191–199 (2012)

Dreicer, R., Gustin, D. M., See, W. A. & Williams, R. D. Paclitaxel in advanced urothelial carcinoma: its role in patients with renal insufficiency and as salvage therapy. J. Urol. 156, 1606–1608 (1996)

Gallagher, D. J. et al. Phase II study of sunitinib in patients with metastatic urothelial cancer. J. Clin. Oncol. 28, 1373–1379 (2010)

Necchi, A. et al. Pazopanib in advanced and platinum-resistant urothelial cancer: an open-label, single group, phase 2 trial. Lancet Oncol. 13, 810–816 (2012)

Seront, E. et al. Phase II study of everolimus in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract: clinical activity, molecular response, and biomarkers. Ann. Oncol. 23, 2663–2670 (2012)

Vaughn, D. J. et al. Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: results of a large phase 2 study. Cancer 115, 4110–4117 (2009)

Sweeney, C. J. et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J. Clin. Oncol. 24, 3451–3457 (2006)

Ko, Y. J. et al. Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: a single group, multicentre, phase 2 study. Lancet Oncol. 14, 769–776 (2013)

Culine, S. et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br. J. Cancer 94, 1395–1401 (2006)

Chen, G. J., Galsky, M. D., Latini, D. M., Sonpavde, G. & DeBakey, M. E. Patterns of chemotherapy and survival in elderly patients with advanced bladder cancer: a large Medicare database study. J. Clin. Oncol. (suppl.) abstr. 4551. (2013)

Okamura, H. et al. Cloning of a new cytokine that induces IFN-γ production by T cells. Nature 378, 88–91 (1995)

Iwai, Y. et al. An IFN-γ-IL-18 signaling loop accelerates memory CD8+ T cell proliferation. PLoS ONE 3, e2404 (2008)

Topalian, S. L. et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N. Engl. J. Med. 366, 2443–2454 (2012)

Dahlberg, S. E., Shapiro, G. I., Clark, J. W. & Johnson, B. E. Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience. J. Natl Cancer Inst. 106, dju163 (2014)

Wolchok, J. D. et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin. Cancer Res. 15, 7412–7420 (2009)

Eisenhauer, E. A. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer 45, 228–247 (2009)