Enfortumab vedotin-ejfv

(Padcev®)

Padcev®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 20 mg/vial, 30 mg/vial)
Drug ClassNectin-4-directed antibodies and microtubule inhibitor conjugates
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer
  • Indicated as a single agent for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum containing chemotherapy
  • Indicated as a single agent for adult patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

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Summary
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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Pembrolizumab plus Enfortumab Vedotin (PEM+EV) demonstrated superior overall survival (OS) in patients with advanced urothelial carcinoma (aUC), with hazard ratios (HR) of 0.60 (95% confidence interval (CI): 0.45-0.81) compared to Nivolumab plus platinum-based chemotherapy, 0.55 (95% CI: 0.42-0.72) compared to PEM plus platinum-based chemotherapy, 0.57 (95% CI: 0.43-0.75) compared to Atezolizumab plus platinum chemotherapy, and 0.47 (95% CI: 0.38-0.58) compared to platinum chemotherapy alone.
  • PEM+EV also showed significant improvement in progression-free survival (PFS), with HR values of 0.62 (95% CI: 0.48-0.82) compared to Nivolumab plus platinum chemotherapy, 0.58 (95% CI: 0.45-0.74) compared to PEM plus platinum chemotherapy, 0.55 (95% CI: 0.43-0.69) compared to Atezolizumab plus platinum chemotherapy, and 0.45 (95% CI: 0.38-0.54) compared to platinum chemotherapy alone.
  • The objective response rate (ORR) for PEM+EV was significantly higher, showing an odds ratio (OR) of 2.63 (95% CI: 2.00-3.45) compared to platinum chemotherapy, indicating a substantial benefit in treatment efficacy.
  • Immunotherapy treatments, including PEM+EV, showed significantly lower adverse events of grade 3 or higher compared to other treatments for advanced urothelial carcinoma. However, the combination of immune checkpoint inhibitors (ICIs) with chemotherapy resulted in an increased risk of immune-related adverse events (P-value = 0.02).
  • While PEM+EV was effective, it was noted that immunotherapy alone (such as Atezolizumab) had the lowest rate of high-grade adverse events among the treatments compared.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Padcev (enfortumab vedotin-ejfv) Prescribing Information.2024Astellas Pharma US, Inc., Northbrook, Illinois

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma.2024Annals of Oncology
NCCN Clinical Practice Guidelines in Oncology. 2020Journal of the National Comprehensive Cancer Network