ADCs Enfortumab Vedotin Receives Accelerated FDA Approval

Urothelial cancer accounts for more than 90% of bladder cancer. Patients diagnosed with metastatic disease have a poor prognosis, with a 5-year survival rate of 5%. Dr. Zhang Wenlong from the Hong Kong Clinical Oncology Department pointed out that currently chemotherapy and PD-1 immunotherapy are the standard treatments for patients with bladder cancer. However, for patients with PD-1 failure, the treatment options are very limited. On December 19, the US FDA approved Enfortumab Vedotin for the treatment of locally advanced or metastatic urothelial cancer patients who have received platinum-based chemotherapy and PD-1 therapy.

This approval is based on EV-201 (Cohort 1) key clinical trial data, which was announced at the 2019 ASCO annual meeting. The patients enrolled in this cohort were patients with locally advanced or metastatic urothelial carcinoma (UC) who had previously received platinum-containing chemotherapy combined with PD-1/PD-L1 inhibitors for the treatment of progressive disease. In addition. They evaluated the efficacy and safety of Enfortumab Vedotin. EV-201 data show that regardless of whether the patient has PD-(L)1 antibody resistance or liver metastasis, it can bring a good response. ORR 44%, the complete remission rate is 12%; median DOR-7.6 months; median PFS-5.8 months; median OS-11.7 months.

According to Dr. Zhang Wenlong from Hong Kong Clinical Oncology Department, Enfortumab Vedotin is an investigational antibody-drug conjugate (ADC), which consists of human IgG1 monoclonal antibody Enfortumab targeting Nectin-4 and cytotoxic agent MMAE(monomethyl auristatin E, Auristatin E, a microtubule breaker) conjugated. Nectin-4 is a therapeutic target highly expressed in a variety of solid tumors including urothelial carcinoma (UC). This therapy was granted breakthrough therapy designation and priority review by the FDA in 2018.

Antibody Conjugate drugs use monoclonal antibodies’ ability to specifically target the surface antigens of cancer cells and deliver drugs to cancer cells, which is a strategy for targeted cancer treatment. The approval of Enfortumab Vedotin also represents a new model for the treatment of advanced urothelial cancer patients.


Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer