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A chemo-free combo for muscle-invasive bladder cancer keeps patients feeling just as well as standard chemotherapy. The phase 3 KEYNOTE-B15 trial found that perioperative enfortumab vedotin plus pembrolizumab showed no clinically meaningful decline in health-related quality of life compared to gemcitabine-cisplatin — while also significantly improving survival outcomes. Both the FDA and European Commission have now approved the regimen for all MIBC patients, regardless of cisplatin eligibility.
The combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) is already making waves for its survival benefits in muscle-invasive bladder cancer (MIBC) — and now new data confirm it doesn't come at the cost of patients' well-being. A prespecified quality-of-life (QOL) analysis from the phase 3 KEYNOTE-B15 trial, presented at the 2026 ESMO Congress, found no clinically meaningful difference in health-related QOL between the immunotherapy-ADC combo and standard gemcitabine-cisplatin chemotherapy across six key domains.
In both arms, the steepest QOL declines occurred after radical cystectomy — the major surgery to remove the bladder — followed by partial recovery. Sexual function was the one domain that didn't bounce back in either group, which researchers noted is consistent with the known impact of this life-altering surgery. Importantly, no domain crossed the threshold for a meaningful worsening (a 10-point drop), and time to definitive deterioration did not differ significantly between arms.
By the Numbers
Why it matters: These QOL findings, combined with superior efficacy data, strengthen the case for enfortumab vedotin plus pembrolizumab as a new standard of care for MIBC. The regimen has now received both FDA and European Commission approval for all MIBC patients undergoing cystectomy, regardless of cisplatin eligibility — offering a chemotherapy-free option that doesn't compromise how patients feel during treatment.
