Astellas Pharma recently announced that the European Commission has granted Marketing Authorization for PADCEV (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.

The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and signficantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.

Dr. Thomas Powles, Barts Cancer Institute Biomedical Research Centre, UK, said; “Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase 3 clinical trial program, with enfortumab vedotin in combination with pembrolizumab significantly extending overall survival and progression-free survival compared to platinum-containing chemotherapy. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting.”

The Phase 3 EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95 per cent CI: 25.4-NR) compared to 16.1 months (95 per cent CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53 per cent reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001).