The European Commission has expanded its approval of the combination of the antibody-drug conjugate Padcev and Keytruda for perioperative treatment of bladder cancer. The treatment is indicated for adults with resectable muscle-invasive bladder cancer, regardless of whether they are eligible for cisplatin.
The European Commission has approved the combination of Padcev (enfortumab vedotin), jointly developed by Astellas Pharma and Pfizer, and pembrolizumab as perioperative treatment for bladder cancer. The indication covers adults with resectable muscle-invasive bladder cancer, regardless of whether they are eligible for cisplatin. The approval was based on results from the EV-304 study.
In the EV-304 study, the combination therapy significantly improved event-free survival and overall survival compared with neoadjuvant chemotherapy, reducing the risk of recurrence, disease progression or death by 47% (HR 0.53, 95% CI 0.41-0.70, one-sided p<0.0001) and the risk of death by 35% (HR 0.65, 95% CI 0.48-0.89, one-sided p=0.0029). The pCR rate was 55.8% with the combination, substantially higher than the 32.5% reported with neoadjuvant chemotherapy (difference 23.4%, 95% CI 16.7-29.8, one-sided p<0.0001).
The safety profile was consistent with previously reported findings, with no new safety signals observed. Grade 3 or higher adverse events occurred in 75.7% of patients in the combination group and 67.2% of those in the neoadjuvant chemotherapy group. Astellas Pharma aims to facilitate rapid access by working with regulatory authorities and health technology assessment bodies in European countries.