Also known as: Padcev, PADCEV
Enfortumab vedotin is an antibody-drug conjugate anti-cancer therapy marketed as Padcev for advanced urothelial cancer settings. It is a nectin-4-directed antibody linked to a microtubule inhibitor payload (MMAE). The FDA first approved it in 2019.
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
Merck announced multiple data presentations at the 2026 ASCO GU Cancers Symposium, including results from trials evaluating pembrolizumab combinations in muscle-invasive bladder cancer and renal cell carcinoma.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Phase III KEYNOTE-B15 trial demonstrates enfortumab vedotin plus pembrolizumab significantly improves event-free survival and pathologic complete response rates compared with cisplatin-based chemotherapy in muscle-invasive bladder cancer.
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
Merck is diversifying its oncology pipeline beyond Keytruda as the blockbuster approaches patent cliffs, focusing on immune modulating therapies, antibody-drug conjugates, and tumor intrinsic treatments through strategic acquisitions and partnerships.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07566156 |
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) |
RECRUITING | PHASE3 |
| NCT07475806 |
A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder |
RECRUITING | PHASE2 |
| NCT07421700 |
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07374549 |
SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07347314 |
Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy |
RECRUITING | PHASE2 |
| NCT07287995 |
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07221942 |
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma |
RECRUITING | PHASE2 |
| NCT07139977 |
Study of EV for Recurrent Endometrial Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07110038 |
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma |
RECRUITING | PHASE2 |
| NCT07087860 |
Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers |
RECRUITING | PHASE2 |
