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GU Cancers 2023 | Updates from KEYNOTE-905: immunotherapy + cystectomy vs cystectomy alone in MIBC

Andrea Necchi, MD, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy, shares the study design and provides updates from the randomized Phase III KEYNOTE-905 trial (NCT03924895) of preoperative pembrolizumab plus cystectomy versus cystectomy alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). In the immunotherapeutic arm, pembrolizumab is then used again as a monotherapy and in combination with enfortumab vedotin for 1 year of adjuvant treatment. There is also third study arm of pembrolizumab monotherapy without cystectomy which is no longer accruing. Coprimary endpoints are pathologic complete response (pCR) and event-free survival (EFS). Secondary endpoints are overall-survival (OS), disease-free survival (DFS), and pathologic downstaging in all patients and in patients with tumor PD-L1 combined positive score (CPS) ≥10. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

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