Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab improves pathological and DFS outcomes in MIBC

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Published: 17 Mar 2026
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Prof Steffen Rausch - University of Tübingen, Tübingen, Germany

Prof Steffen Rausch speaks to ecancer about the KEYNOTE-905 study.

This study evaluated neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer undergoing radical cystectomy with pelvic lymph node dissection.

With a median follow-up of 25.6 months, enfortumab vedotin plus pembrolizumab significantly improved pathological complete response (pCR; 57.1% vs 8.6%), pathological down-staging (pDS; 65.9% vs 12.6%), and disease-free survival (median DFS not reached versus 23.6 months; HR 0.37) compared to radical cystectomy with pelvic lymph node dissection alone.

Surgical outcomes, including complete resection and negative margins, were also favourable in the enfortumab vedotin plus pembrolizumab arm.

Prof Rausch concludes by saying that these results support perioperative enfortumab vedotin plus pembrolizumab as a promising standard of care for cisplatin-ineligible MIBC, offering substantial improvements in tumour eradication and DFS.

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