The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

The Breakthrough Therapy Designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs.

Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545).

Seattle Genetics and Astellas are also evaluating enfortumab vedotin in other solid tumours, including ovarian and non-small cell lung carcinoma.

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology.

Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumours.

“The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population,” said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. “Seattle Genetics is an emerging multi-product oncology company, advancing a robust pipeline with the goal of improving outcomes for cancer patients. Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible.”

“Achieving Breakthrough Therapy Designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most,” said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. “With the enfortumab vedotin registrational phase 2 trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers.”

Source: BusinessWire