The Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (PADCEV, Astellas Pharma) for 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 a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
Enfortumab vedotin-ejfv is the first Nectin-4-directed antibody-drug conjugate to receive FDA approval.
Efficacy was investigated in EV-201, a single-arm, multicenter trial enrolling 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. Patients received enfortumab vedotin-ejfv 1.25 mg/kg on days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
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The main efficacy outcome measures were confirmed objective response rate (ORR) and response duration as assessed by blinded independent central review using RECIST 1.1. The ORR was 44% (95% CI: 35.1, 53.2) with complete and partial response rates of 12% and 32%, respectively. The estimated median response duration was 7.6 months (95% CI: 6.3, not estimable).
The most common adverse reactions (≥20%) included fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus and dry skin. Diabetic ketoacidosis and death have occurred in patients treated with enfortumab vedotin-ejfv, regardless of pre-existing diabetes mellitus. Blood glucose levels should be monitored closely in patients with, or at risk, for diabetes mellitus or hyperglycemia.
The recommended enfortumab vedotin-ejfv dose is 1.25 mg/kg (up to a maximum dose of 125 mg) administered as an intravenous infusion over 30 minutes on days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.