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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

Journal of Clinical Oncology Nov 20, 2018

Necchi A, et al. - In the PURE-01 study, researchers aimed at evaluating the activity of pembrolizumab as neoadjuvant immunotherapy prior to radical cystectomy (RC) for muscle-invasive bladder carcinoma (MIBC) that is poorly used in standard cisplatin-based chemotherapy. Study participants were patients (receiving three cycles of pembrolizumab 200 mg every 3 weeks before RC) with a predominant urothelial carcinoma histology and clinical (c)T≤3bN0 stage tumor. Neoadjuvant pembrolizumab resulted in 42% of pathologic complete response (pT0) patients and was administered safely in MIBC patients. Hence, for the treatment of MIBC, and when limited to patients with programmed death-ligand 1 (PD-L1)–positive or high-tumor mutation burden (TMB) tumors, pembrolizumab seems to be a valuable neoadjuvant therapy.
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