Treatment regimen

Enfortumab vedotin with pembrolizumab (EV-302)

First line in advanced urothelial cancer

Updated: 28 October 20261 min read2 references

Summary for doctors

  • First line in advanced urothelial cancer, regardless of cisplatin eligibility [1].
  • It nearly doubled patients' survival [1].
  • Specific toxicities: severe skin reactions, neuropathy, hyperglycaemia and eye problems.

Dose and schedule

EV + pembrolizumab

Advanced urothelial cancer, first lineCycle length: Every 21 days

Advanced urothelial cancer, first line

DrugDoseRouteSchedule
Enfortumab vedotin1.25 mg/kg (maximum 125 mg)IV over 30 minutesDays 1 and 8
Pembrolizumab200 mgIVDay 1
Cycle length
Every 21 days
Duration
Until progression; pembrolizumab up to 35 cycles

Doses as in EV-302 [1].

Dose source: [2].

Evidence: EV-302 (KEYNOTE-A39) (2024)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Premedication and supportive care

  • Lubricating eye drops; baseline glucose and before each cycle (great caution with uncontrolled diabetes, HbA1c above 8).
  • Rash: early topical steroids; blisters or mucosal involvement: stop immediately and assess for SJS/TEN.

Monitoring and dose adjustment

  • Grade 2 neuropathy: hold until grade 1, then continue at the same dose (first time) or one level lower (recurrence); reduction levels 1, 0.75 and 0.5 mg/kg; grade 3 or more: stop.
  • TSH, glucose, liver enzymes and creatinine at baseline and every 6 weeks; immune-related toxicity as in the immunotherapy toxicity lesson.

Main evidence

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EV-302: median overall survival 31.5 vs 16.1 months and progression-free survival 12.5 vs 6.3 months with platinum chemotherapy [1].

Related cancer types

References

2 references
Show all references, 1 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial CancerPowles T, Valderrama BP, Gupta S, et al · N Engl J Med · 2024;390:875-888
    Study cardDOIPubMed Back to text: 1 2 3 4
  2. 2
    PADCEV EJFV (ENFORTUMAB VEDOTIN) — Prescribing InformationSeagen Inc · FDA label · 2026

This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.