EV+pembro preserves HRQoL in MIBC
By Sudha Thakor
Perioperative enfortumab vedotin (EV) plus pembrolizumab added to radical cystectomy with standard pelvic lymph node dissection preserves health-related quality of life (HRQoL) compared with cystectomy alone in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), according to findings from the phase 3 KEYNOTE-905 study (NCT03924895).
Presenting at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 in Chicago, USA, Peter H. O'Donnell (University of Chicago, Chicago, USA) reported that EV plus pembrolizumab “preserved health-related quality of life over time compared to cystectomy alone.”
At 18 weeks after surgery, mean changes from baseline in global HRQoL, cystectomy-specific outcomes, and overall health status were similar between treatment arms and did not exceed thresholds for clinically meaningful deterioration.
These findings build on previously reported efficacy results from KEYNOTE-905/EV-303, in which perioperative EV plus pembrolizumab improved event-free survival, overall survival, and pathological complete response versus cystectomy alone.
Across validated patient-reported outcome instruments—including FACT-G, FACT–Bl-Cys, Bladder Cancer Index (BCI), and EQ-5D-5L—changes over time remained small and comparable between groups. O'Donnell noted that “mean changes did not exceed the established thresholds for a clinically meaningful deterioration,” supporting the overall tolerability of the regimen from a patient perspective.
Completion rates for HRQoL assessments at the primary timepoint exceeded 65% in the EV plus pembrolizumab group and 86% in the control group. These data underpin the robustness of the analysis despite the intensity of perioperative treatment.
Declines in bowel and sexual function were observed in both arms, consistent with the known impact of radical cystectomy. These changes were most pronounced early after surgery, with recovery trends over time for some domains. Urinary outcomes showed minimal overall change, with some improvement observed during the neoadjuvant phase in the EV plus pembrolizumab arm.
KEYNOTE-905 enrolled patients with MIBC who were ineligible for or declined cisplatin and randomized them to perioperative EV plus pembrolizumab with cystectomy or cystectomy alone. Patients in the experimental arm received neoadjuvant therapy, surgery, and adjuvant treatment, reflecting an intensified perioperative approach.
O'Donnell concluded that, alongside demonstrated efficacy benefits, these patient-reported outcome data “support the overall benefit-risk profile” of perioperative EV plus pembrolizumab in this population.
Further follow-up is ongoing to assess longer-term outcomes.
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