Dr. Glaucomflecken Explains: Enfortumab Vedotin and Pembrolizumab in Bladder Cancer (KEYNOTE-905)
Why It Matters
The data offers a curative‑intent alternative for patients previously limited to surgery, reshaping bladder‑cancer care and drug development pipelines.
Key Takeaways
- •KEYNOTE-905 tested Enfortumab Vedotin plus Pembrolizumab pre‑surgery.
- •Enrolled 340 cisplatin‑ineligible muscle‑invasive bladder cancer patients.
- •Combination therapy significantly improved 2‑year event‑free survival.
- •Surgery alone remained standard control arm in trial.
- •Results may expand neoadjuvant options for non‑cisplatin patients.
Summary
The video reviews the New England Journal of Medicine publication of the phase III KEYNOTE‑905 trial, which evaluated neoadjuvant Enfortumab Vedotin combined with Pembrolizumab in patients with muscle‑invasive bladder cancer who could not receive cisplatin‑based chemotherapy.
The study randomized 340 eligible patients to receive the antibody‑drug conjugate plus checkpoint inhibitor followed by radical cystectomy, or to undergo surgery alone. The primary endpoint was event‑free survival (EFS) at two years. The combination arm achieved a statistically significant improvement in EFS compared with surgery alone, with a hazard ratio around 0.55 and an absolute benefit of roughly 15‑20 percentage points.
The presenter highlighted the NEJM article’s headline that “Enfortumab Vedotin plus Pembrolizumab improves event‑free survival,” noting that the regimen was well tolerated and that pathological complete response rates doubled relative to control. He also joked about the tongue‑twisting drug names, underscoring the need for urologic oncologists to stay current.
If validated, this regimen could become the new neoadjuvant standard for cisplatin‑ineligible patients, expanding curative intent options and potentially shifting treatment algorithms across urologic oncology practices.
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