Astellas Pharma Inc. and Seagen Inc. (Nasdaq:SGEN) have announced that the European Commission (EC) has approved PADCEV (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.
“The approval of enfortumab vedotin in the European Union is a significant milestone for people living with advanced urothelial cancer who have had limited treatment options and poor survival rates,” said Ahsan Arozullah, M.D., M.P.H., Vice President, Medical Sciences-Oncology, Astellas. “We look forward to working with health authorities to ensure people living with advanced urothelial cancer can access this new treatment option as soon as possible.”
The EV-301 trial compared enfortumab vedotin to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of the pre-specified interim analysis, patients who received enfortumab vedotin (n=301) in the trial lived a median of 3.9 months longer than those who received chemotherapy (n=307). Median OS was 12.9 vs. 9 months, respectively [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. Across clinical trials, the most common adverse reactions with enfortumab vedotin were alopecia, fatigue, decreased appetite, peripheral sensory neuropathy, diarrhea, nausea, pruritus, dysgeusia, anemia, weight decreased, rash maculo-papular, dry skin, vomiting, aspartate aminotransferase increased, hyperglycemia, dry eye, alanine aminotransferase increased and rash.
“The EV-301 study is the first randomized trial to show improved overall survival in patients with advanced urothelial cancer who received a platinum-containing chemotherapy and an immunotherapy,” said Professor Ignacio Durán, M.D., Ph.D., Hospital Universitario Marqués de Valdecilla, Spain. “This approval of enfortumab vedotin from the European Commission is an important moment for these patients and their physicians.”
Results from the EV-301 trial are intended to support global registrations for enfortumab vedotin. The EC marketing authorization for enfortumab vedotin is applicable in the European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein.
Urothelial cancer is the most common type of bladder cancer. In Europe, an estimated 204,000 people were diagnosed with urothelial cancer in 2020, and more than 67,000 died as a result of the disease. Enfortumab vedotin is the first antibody-drug conjugate authorized in the EU for people living with urothelial cancer.