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Enfortumab vedotin plus pembrolizumab
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Enfortumab vedotin is an antibody-drug conjugate, combining an antibody that binds to nectin-4 with a microtubule inhibitor. The U.S. Food and Drug Administration (FDA) approved enfortumab vedotin as monotherapy for patients with previously treated metastatic urothelial carcinoma. Pembrolizumab is an anti−programmed death-1 (PD-1) antibody that the FDA has approved as monotherapy for patients with metastatic bladder cancer. The combination of the two agents showed a promising response rate and duration of response, leading to a single-arm phase II trial and then a comparison with chemotherapy in a randomized, controlled, phase III trial.[2-4] While results cannot be extrapolated across trials, enfortumab vedotin plus pembrolizumab is a first-line therapy option for patients without a contraindication.
Evidence (enfortumab vedotin plus pembrolizumab):
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
Source links and citations
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
Overall survival (OS) and progression-free survival (PFS) were longer for patients in the enfortumab vedotin-plus-pembrolizumab arm than in the chemotherapy arm.
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
The median OS was 31.5 months for patients who received enfortumab vedotin plus pembrolizumab and 16.1 months for patients who received chemotherapy (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.38–0.58; P < .001).
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
PFS was 12.5 months for patients who received enfortumab vedotin plus pembrolizumab and 6.3 months for patients who received chemotherapy (HR, 0.45; 95% CI, 0.38–0.54; P < .001).
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
Grade 3 or higher adverse events occurred in 55.9% of patients who received enfortumab vedotin plus pembrolizumab and 69.5% of patients who received chemotherapy.
In a phase III trial (EV-302 [NCT04223856]), 886 patients were randomly assigned to receive either enfortumab vedotin plus pembrolizumab (n = 442) or gemcitabine plus either cisplatin or carboplatin (n = 444). The median follow-up was 17.2 months.[4][Level of evidence A1]
In the experimental arm, the most common high-grade adverse events were skin reactions, peripheral neuropathy, hyperglycemia, and neutropenia.
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