Enfortumab vedotin is an antibody-drug conjugate designed for the treatment of cancer expressing Nectin-4.
Its payload toxin of MMAE (auristatin): which is a tubulin toxin.
Approved to treat adult patients with locally advanced or metastatic urothelial cancers who have received prior treatments with PD-1/ PD-L1 inhibitor and platinum containing chemotherapy.
Enfortumab refers to the monoclonal antibody part.
Vedotin refers to the payload drug and the linker.
Target Nectin-4
Trade name Padcev.
Routes of administration IV
Pregnancy category AU: D
Enfortumab progression free survival extended from 3.7 months to 5.6 months with an objective response rate of 40.6%.
Common side effects: fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritus, and dry skin.
The initial clinical trial enrolled 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.
The overall response rate, was 44%, with 12% having a complete response and 32% having a partial response.
The median duration of response was 7.6 months.
EV-301 study enfortumab extended overall survival from the median of nine months with chemotherapy with taxane to more than 12.9 months
Enfortumab progression free survival extended from 3.7 months to 5.6 months with an objective response rate of 40.6%.
Enfortumab vedotin is indicated for the treatment of adults 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.
Enfortumab plus pembrolizumab doubled the overall survival of patients versus chemotherapy in metastatic urothelial cancer.