Astellas Pharma Ltd. today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for PADCEV TM (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 indication is based on results of the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39).
The Phase 3 clinical trial 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 . “The foundations of advanced bladder cancer treatment haven’t changed since the 1980s,” said Professor. Thomas Powles, Director of Barts Cancer Institute Biomedical Research Centre (QMUL), UK and primary investigator on the EV-302 trial , “to see EV-302 move from clinical trial to licensed indication within a year shows the strength of those results and the potential benefit to people with advanced bladder cancer.
” Advanced bladder cancer has a poor prognosis compared to other forms of cancer. Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor. Only 10 % of patients with stage 4 bladder cancer survive for more than 5 years after dia.