Updated 5-year Survival Results from PURE-01, a Phase 2 Study of Neoadjuvant Pembrolizumab Followed by Radical Cystectomy in Patients with Muscle-invasive Bladder Cancer.

Valentina Tateo¹, Giuseppe Basile², Patrizia Giannatempo³, Joep J de Jong⁴, James A Proudfoot⁵, Brigida A Maiorano⁶, Antonio Cigliola⁷, Chiara Mercinelli⁷, Elai Davicioni⁵, Marco Moschini⁸, Giovanni Tremolada⁸, Simone Rota³, Giorgio Brembilla⁹, Maurizio Colecchia¹⁰, Francesco De Cobelli⁹, Francesco Montorsi⁸, Andrea Necchi⁷

¹Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy. Electronic address: tateo.valentina@hsr.it.

²Department of Urology, IRCCS Ospedale San Raffaele, Milan, Italy.

³Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

⁴Department of Urology, Erasmus University Medical Center, Rotterdam, Netherlands.

⁵Veracyte, Inc., South San Francisco, CA, USA.

⁶Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy.

⁷Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

⁸Department of Urology, IRCCS Ospedale San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.

⁹Vita-Salute San Raffaele University, Milan, Italy; Department of Radiology, IRCCS Ospedale San Raffaele, Milan, Italy.

¹⁰Vita-Salute San Raffaele University, Milan, Italy; Department of Pathology, IRCCS Ospedale San Raffaele, Milan, Italy.

PubMed DOI

Abstract

The PURE-01 trial evaluated three cycles of pembrolizumab 200 mg followed by radical cystectomy (RC) in patients with cT2-3b N0 M0 muscle-invasive bladder cancer (MIBC) ineligible for or refusing cisplatin. A total of 155 patients were treated. We report survival outcomes after median follow-up of >60 mo and associations with pathological response rates and biomarker levels. In the intention-to-tr…

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