Enfortumab Vedotin + Pembrolizumab: Superiority over Chemotherapy Proven in MIBC
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The KEYNOTE-B15 (EV-304) study: A major advance in survival with a chemotherapy-free perioperative regimen.
In muscle-invasive bladder cancer (MIBC), "cisplatin-based chemotherapy", the gold standard for decades, is now giving way to a combination of the targeted antibody-drug conjugate (ADC) enfortumab vedotin and the immunotherapy pembrolizumab . The KEYNOTE-B15 study demonstrated the undisputed superiority of this duo, given before and after surgery, over conventional chemotherapy in both complete response and survival.
A Huge Increase in Pathological Complete Response (pCR)
Among the study's most striking findings are the rates of pathological complete response, meaning that no cancer cells remain in the bladder after surgery. A complete response was achieved in approximately 56% of patients receiving the combination treatment, whereas the rate remained at 32.5% with standard chemotherapy.
This success in "downstaging" (reducing the disease stage) not only improves surgical success but also substantially increases patients' chances of stepping into a disease-free future.
The Strength of the Clinical Data
The combination treatment nearly halved the risk of disease progression, recurrence, or death compared with chemotherapy.
The risk of death was reduced by 35%. At two years of follow-up, the survival rate reached a record 86.9%.
For the first time, a "non-platinum" regimen produced superior outcomes to conventional chemotherapy even in patients eligible for cisplatin.
As physicians, our greatest concern is the high risk of recurrence after bladder cancer surgery. The KEYNOTE-B15 study is a turning point that transforms this concern into hope. Enfortumab vedotin's entry into the cancer cell like a "Trojan horse" and pembrolizumab's stimulation of the immune system have become one of oncology's most successful partnerships.
We can now offer our patients not just chemotherapy, but an option that is biologically smarter and more successful in terms of survival. These data are striking enough to completely change our clinical practice in treating MIBC.
Scientific References
- 1. Aragon-Ching JB, et al. KEYNOTE-B15: Enfortumab Vedotin Plus Pembrolizumab Improves OS, EFS, pCR Rates. ASCO Daily News, Feb 2026.
- 2. Galsky MD, et al. Randomized Phase 3 Study of Perioperative EV + Pembro vs Chemotherapy in MIBC (KEYNOTE-B15/EV-304). ASCO GU Symposium 2026.
- 3. Merck & Pfizer Joint News Release: Survival Benefits of Perioperative Pembrolizumab and Enfortumab Vedotin in MIBC.
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