A New Era Before Bladder Cancer Surgery: What Did KEYNOTE-B15 Show?
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ASCO GU 2026 UPDATED ANALYSIS
Enfortumab Vedotin Plus Pembrolizumab Breaks New Ground in Bladder Cancer Survival
KEYNOTE-B15 (EV-304) 24-Month Results: A chemotherapy-free perioperative regimen raises disease-free survival (DFS) to 83%.
Until now, patients with muscle-invasive bladder cancer (MIBC) who cannot receive standard cisplatin-based chemotherapy because of comorbidities were treated with radical cystectomy (bladder removal) alone, with a substantial risk of recurrence. However, updated 2026 data from **KEYNOTE-B15 (EV-304)** demonstrated that the combination of enfortumab vedotin and pembrolizumab administered before and after surgery dramatically reduced recurrence risk for these patients.
A Doubling of DFS at 24 Months
According to results presented at ASCO GU 2026, disease-free survival (DFS) rates increased tremendously among patients receiving combination therapy compared with those undergoing surgery alone. At 24 months of postoperative follow-up, the proportion remaining disease-free in the combination group reached %83, whereas it remained at 50% in the surgery-only group.
This achievement rests on the powerful synergy between enfortumab vedotin, an antibody-drug conjugate (ADC) that enters cancer cells like a "Trojan horse," and pembrolizumab, which reactivates the immune system.
LITESPARK-011: Success in Numbers
Combination therapy dramatically reduced the risk of disease recurrence or death in MIBC patients compared with standard surgery (HR 0.37).
With a pathological complete response (pCR) rate of 57.1% in postoperative tissue, combination therapy "melted away" the cancer and guaranteed surgical success.
These 24-month data show that the combination not only delayed the disease but also contributed to completely clearing cancer cells from the body.
A new dawn in bladder cancer
As physicians, our greatest concern after bladder cancer surgery is the high risk of recurrence. The KEYNOTE-B15 study marks a turning point that transforms this concern into hope. Enfortumab vedotin entering cancer cells like a "Trojan horse" and pembrolizumab activating the immune system have become one of oncology's most successful partnerships.
We can now offer our patients not only chemotherapy but also a biologically smarter option with greater survival success. These data are so striking that they will completely change our clinical practice in MIBC treatment.
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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