A Phase 3 trial showed that combining Pfizer and Astellas’s antibody–drug conjugate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) improved overall survival for a subset of bladder cancer patients. The companies announced the positive topline result and said they will engage regulators to pursue expanded indications based on the data. Sponsors plan regulatory discussions to support label changes and potential accelerated review pathways. The trial enrolled patients with advanced urothelial carcinoma and measured survival outcomes against standard regimens; detailed subgroup analyses and full data readouts are expected ahead of formal submissions. The regimen pairs an ADC that targets tumor antigens with an anti–PD‑1 immune checkpoint inhibitor — a combination strategy designed to elicit direct tumor kill plus immune activation. Companies involved will need to supply safety, durability and biomarker data to regulators to define the target patient population for approval.