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The enfortumab vedotin + pembrolizumab combo is cementing its place as a new standard of care for muscle-invasive bladder cancer (MIBC). New ad hoc data from KEYNOTE-905 confirm both drugs independently contribute to the regimen's impressive survival benefits, while the European Commission has now approved the combo for all MIBC patients regardless of cisplatin eligibility — mirroring the FDA's expanded approval from July 2026.
The perioperative combination of enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) is rapidly reshaping the treatment landscape for muscle-invasive bladder cancer (MIBC). A new ad hoc analysis from the phase 3 KEYNOTE-905 trial, presented at the 2026 ESMO Congress, shows that both agents independently contribute to the regimen's efficacy — with the combo delivering a median event-free survival (EFS) that was not reached, compared to 28.7 months with pembrolizumab alone and 15.7 months with surgery alone in cisplatin-ineligible patients.
On the regulatory front, the European Commission approved the combination as perioperative treatment for all resectable MIBC patients, regardless of cisplatin eligibility — backed by the phase 3 KEYNOTE-B15/EV-304 trial. This mirrors the FDA's July 2026 expanded approval, and marks the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in the EU for MIBC across all cisplatin eligibility groups.
By the Numbers:
Why it matters: These converging data points — new mechanistic evidence and sweeping regulatory approvals on both sides of the Atlantic — position enfortumab vedotin plus pembrolizumab as a chemotherapy-free standard of care for MIBC patients, regardless of their ability to tolerate cisplatin.
