Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 20 mg/vial, 30 mg/vial) |
Drug Class | Nectin-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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Padcev (enfortumab vedotin-ejfv) Prescribing Information. | 2024 | Astellas Pharma US, Inc., Northbrook, Illinois |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ESMO Clinical Practice Guideline interim update on first-line therapy in advanced urothelial carcinoma. | 2024 | Annals of Oncology |
NCCN Clinical Practice Guidelines in Oncology. | 2020 | Journal of the National Comprehensive Cancer Network |