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Is This the End of the Cisplatin Eligibility Era in Muscle-invasive Bladder Cancer? Letter in reference to: Matthew D. Galsky, Begoña P. Valderrama, Marco Maruzzo, et al. Enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer. N Engl J Med 2026;395:338–48. doi:10.1056/NEJMoa2601486; and Galsky MD, Hahn NM, Rosenberg J, et al. A consensus definition of patients with metastatic urothelial carcinoma who are unfit for cisplatin-based chemotherapy. Lancet Oncol 2011;12:211–214. doi:10.1016/S1470-2045(10)70275-8

European Urology·September 18
Urology & NephrologyPractice changingMetastatic Urothelial CarcinomaMuscle-Invasive Bladder CancerEditorial / LetterAntibody-Drug ConjugateImmune Checkpoint InhibitorPlatinum-Based ChemotherapyKeytrudaPadcevCisplatinEnfortumab VedotinPembrolizumab

Summary

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What was studied

This letter critically examines the implications of the EV-302/KEYNOTE-869 trial (enfortumab vedotin + pembrolizumab in cisplatin-eligible muscle-invasive/metastatic bladder cancer) and questions whether the traditional cisplatin-eligibility framework—established by Galsky et al. in 2011—remains relevant in the current treatment landscape.

Key findings

The letter argues that strong efficacy data for enfortumab vedotin + pembrolizumab in cisplatin-eligible patients may render the cisplatin-eligibility distinction clinically obsolete, challenging the longstanding practice of reserving certain regimens for cisplatin-ineligible patients only.

Study limitations

This is an editorial letter, not an original study—no new primary data or patient-level outcomes are reported. Conclusions are interpretive and based on referenced trial results rather than independent analysis.

Clinical implications

Clinicians should reconsider defaulting to cisplatin-based chemotherapy as the standard first-line regimen for muscle-invasive bladder cancer; the enfortumab vedotin + pembrolizumab combination may be appropriate regardless of cisplatin eligibility status, pending guideline updates.

Caveats

  • No sample size is applicable to this letter itself.
  • The referenced trial (Galsky et al., NEJM 2026) was published in January 2026; this letter responds to it in September 2026—the full trial data are not reproduced here and should be reviewed independently.
  • This is a letter/editorial, not a primary research study—no original patient data are presented. Conclusions are the authors' interpretations of the referenced EV-302/KEYNOTE-869 trial results.

Related Questions

Explore related topics

What are the latest guidelines on first-line treatment for cisplatin-eligible metastatic urothelial carcinoma?How does enfortumab vedotin plus pembrolizumab compare to cisplatin-based chemotherapy in bladder cancer outcomes?Should cisplatin eligibility criteria still guide treatment decisions in muscle-invasive bladder cancer?

Publication Details

Year
2026
Journal
European Urology
Source
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