Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants with cisplatin-ineligible muscle-invasive bladder cancer (MIBC): An analysis of clinically relevant subgroups in KEYNOTE-905.

Key Points

This study aims to analyze the efficacy of neoadjuvant and adjuvant enfortumab vedotin with pembrolizumab in specific subgroups of muscle-invasive bladder cancer patients.
Patients with cisplatin-ineligible muscle-invasive bladder cancer were randomly assigned to receive either enfortumab vedotin plus pembrolizumab and radical cystectomy with pelvic lymph node dissection or control treatment.
Event-free survival, overall survival, and pathological complete response rates were analyzed in various clinical subgroups.
The study involved a total of 344 patients.
Event-free survival in T2N0 patients was not reached for both groups, with HR 0.26; 95% CI 0.08-0.80.
In T3-T4aN0 patients, median event-free survival was not reached for EV + pembro versus 17.2 months for control (HR 0.43; 95% CI 0.29-0.63).
Pathological complete response rate was significantly higher in EV + pembro group—57.1% vs 6.8% in T3-T4aN0 group.

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Shows enhanced survival in muscle-invasive bladder cancer with combined therapy, suggesting effective treatment options.

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Adra et al. (2026) studied this question.

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