Study
| Phase 3, global, open-label randomized trial (EV-302/KEYNOTE-A39) |
| Untreated locally advanced or metastatic urothelial carcinoma (cisplatin-eligible or ineligible) |
| Enfortumab vedotin + pembrolizumab vs. platinum-based chemotherapy (gemcitabine + cisplatin or carboplatin) |
Efficacy
| mPFS: 12.5 mos vs. 6.3 mos (enfortumab + pembro vs. chemo) (HR: 0.48 [0.41–0.57]) |
| mOS: 33.8 mos vs. 15.9 mos (HR: 0.51 [0.43–0.61]) |
| ORR: 67.5% vs. 44.2% |
| mDOR: 23.3 mos vs. 7.0 mos |
| cCR rate: 30.4% vs. 14.5% |
| DOCR at 24 mos: 74.3% vs. 43.2% |
Safety
| Grade ≥3 TRAEs: 57.3% vs. 69.5% |
| Peripheral neuropathy (51.8% vs. 9.9%), pruritus (40.7% vs. 4.8%), rash maculo-papular (32.7% vs. 3.2%), anemia (14.8% vs. 56.6%), neutropenia (9.8% vs. 41.6%), thrombocytopenia (4.1% vs. 34.2%) |
| TRAEs leading to death: 1.1% vs. 0.9% |
Ann Oncol. Accepted May 22, 2025
http://doi.org/10.1016/j.annonc.2025.05.536
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
