by Dr. C.H. Weaver M.D. updated 6/2019
There are currently no approved treatment options for patients with advanced bladder cancer after standard chemotherapy and immune treatments, but the results of a phase II clinical trial presented at the June 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago appear promising.(2)
The U.S. Food and Drug Administration (FDA) previously granted Breakthrough Therapy Designation to enfortumab vedotin (EV) for patients with locally advanced or metastatic urothelial (bladder) cancer who were previously treated with checkpoint inhibitors.(1)
Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
About Enfortumab Vedotin
Enfortumab vedotin is a novel precision cancer medicine known as an antibody drug conjugate, a type of therapy that combines an antibody that targets a specific protein on the surface of tumor cells with a payload of powerful chemotherapy.
It is composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target which is expressed on many solid tumors. This antibody is chemically linked with an agent that penetrates the tumor cell and destroys its structure.
In the multi-institutional clinical trial reported at ASCO EV produced responses in 44% of patients with locally advanced or metastatic urothelial cancer who had been previously treated with chemotherapy and checkpoint inhibitors.
Among 125 patients who had received both standard chemotherapy plus a checkpoint inhibitor and EV, 12% had a complete response with no detectable sign of cancer and the median overall survival was 11.7 months. Notably, 38% of people whose cancer had spread to the liver responded to the treatment.
EV is undergoing continued evaluation in comparative trials for FDA approval and being combined with other precision cancer medicines and immunotherapies like Keytruda in order to determine its optimal use.