The 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 (CPIs).
“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., Vice President, Clinical Development at Seattle Genetics.
“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,” commented Steven Benner, Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas.
“With the enfortumab vedotin registrational Phase II 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,” Benner concluded.
The Breakthrough Therapy Designation was awarded based on interim results from the Phase I study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer and other solid tumors. Data from the study’s metastatic urothelial carcinoma cohort demonstrated that the ADC had a 41% overall response rate among 71 evaluable patients. The overall response rate at the recommended phase II dose was 53%.
Enfortumab vedotin is also 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 either pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®), EV-103 (NCT03288545). Additionally, the drugs are being evaluated in other solid tumors including ovarian and non-small cell lung carcinoma.