For the management of bladder cancer, 2018 has been characterized by deepened knowledge on the molecular basis of invasive bladder cancer and its potential interaction with existing therapies, optimization of the use of immune checkpoint inhibitors, and emerging early signals on new therapeutic classes for advanced disease.
Key advances
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The Cancer Genome Atlas performed a comprehensive characterization of muscle-invasive bladder cancer (MIBC) in a large cohort and proposed a framework of molecular subtypes with potential therapeutic approaches to inform future clinical trial design1.
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The phase III RAZOR trial reported noninferior 2-year progression-free survival between robot-assisted radical cystectomy and open radical cystectomy2.
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The phase II PURE-01 study reported that patients with MIBC and high programmed cell death 1 ligand 1 (PD-L1) expression had the highest response rates to neoadjuvant pembrolizumab5, warranting further evaluation in larger cohorts.
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The phase III IMvigor211 trial did not report an overall survival benefit with atezolizumab over cytotoxic chemotherapy in locally advanced or metastatic urothelial carcinoma7.
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Preliminary phase II findings demonstrated the efficacy of the fibroblast growth factor receptor 3 (FGFR3) inhibitor erdafitinib in metastatic urothelial cancer, leading to FDA Breakthrough Therapy Status for this drug10.
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References
Robertson, A. G. et al. Comprehensive molecular characterization of muscle-invasive bladder cancer. Cell 171, 540–556 (2017).
Parekh, D. J. et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet 391, 2525–2536 (2018).
Linares-Espinos, E. & Sanchez-Salas, R. Re: robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Eur. Urol. https://doi.org/10.1016/j.eururo.2018.08.001 (2018).
Giannarini, G., Crestani, A. & Ficarra, V. Re: robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Eur. Urol. 74, 840–841 (2018).
Necchi, A. et al. Pembrolizumab as neoadjuvant therapy before radical cystectomy in patients with muscle-invasive urothelial bladder carcinoma (PURE-01): an open-label, single-arm, phase II study. J. Clin. Oncol. 36, 3353–3360 (2018).
Bellmunt, J. et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N. Engl. J. Med. 376, 1015–1026 (2017).
Powles, T. 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. Lancet 391, 748–757 (2018).
Teo, M. Y. & Rosenberg, J. E. EMA and FDA prune the checkpoint inhibitor treatment landscape. Nat. Rev. Urol. 15, 596–597 (2018).
Pal, S. K. et al. Efficacy of BGJ398, a fibroblast growth factor receptor 1–3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 Alterations. Cancer Discov. 8, 812–821 (2018).
Siefker-Radtke, A. O. et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt) [abstract]. J. Clin. Oncol. 36 (Suppl. 15), 4503 (2018).
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J.E.R. has received consulting fees from Genentech/Roche, AstraZeneca, Bristol-Myers Squibb, Seattle Genetics, Merck, Bayer, EMD Serono, Astellas, Sensiei Biotherapeutics, Pharmacyclics, Inovio, Gritstone, Western Oncolytics, Bioclin, QED Therapeutics, Adicet Bio, Fortress Biotech and Mirati Research; funding (for industry trials) from Genentech/Roche, Astellas and Bayer; and research funding (investigator-initiated trials) from Novartis and Genentech/Roche. M.Y.T. has received research funding (investigator-initiated trial) from Bristol-Myers Squibb and funding (for industry trials) from Clovis Oncology.
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Teo, M.Y., Rosenberg, J.E. Refining existing knowledge and management of bladder cancer. Nat Rev Urol 16, 75–76 (2019). https://doi.org/10.1038/s41585-018-0137-3
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DOI: https://doi.org/10.1038/s41585-018-0137-3