Drug updated on 9/4/2024
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 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 for adult patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Latest News
Summary
- Padcev (enfortumab vedotin-ejfv) is indicated in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer; 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; and for adult patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
- This summary is based on the review of three systematic reviews/meta-analyses. [1-3]
- Objective Response Rate (ORR) and Duration of Response (DOR): Enfortumab vedotin (EV) demonstrated an ORR of 47% in patients with locally advanced or metastatic urothelial carcinoma. In a pivotal Phase II trial, EV showed an ORR of 44% with a median DOR of 7.6 months.
- Overall Survival (OS) and Progression-Free Survival (PFS): EV demonstrated an estimated OS of 11.7 months and a median estimated PFS of 5.6 months. Immune checkpoint inhibitors (ICIs) used as switch-maintenance therapy significantly improved OS (21.4 vs. 14.3 months, HR 0.69, 95% CI 0.56-0.86, p=0.001) in patients who had achieved at least stable disease following first-line platinum-based chemotherapy.
- Comparative Effectiveness: ICIs did not improve OS when combined with first-line chemotherapy but did improve OS when used as switch-maintenance therapy. EV, in combination with pembrolizumab, is noted as a potential option for chemotherapy-ineligible patients.
- One study identifies enfortumab vedotin (EV) as having unique toxicity concerns that require careful monitoring, but these toxicities are described as manageable.
- Another study mentions that the safety profiles of immune checkpoint inhibitors (ICIs) when combined with chemotherapy vary, but specific adverse effects are not detailed in the studies.
- Enfortumab vedotin (EV) was effective in challenging subgroups, such as patients with liver metastases, with similar outcomes observed across these populations, while immune checkpoint inhibitors (ICIs) significantly improved overall survival in patients with stable disease after first-line platinum-based chemotherapy. ICIs may also benefit platinum-ineligible patients, and when combined with EV, offer a viable option for chemotherapy-ineligible patients.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Padcev (enfortumab vedotin-ejfv) Prescribing Information. | 2023 | 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 |
Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology. | 2020 | Journal of the National Comprehensive Cancer Network |
Treating bladder cancer. | 2020 | American Cancer Society |