The European Commission (EC) has granted approval to the combination of KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin) as a first-line treatment for unresectable or metastatic urothelial carcinoma in adults. This approval aligns with recent guidelines recommending the combination as the preferred initial treatment approach.
The approval is based on findings from the KEYNOTE-A39 trial, which demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) with KEYTRUDA plus enfortumab vedotin compared to platinum-based chemotherapy. The risk of death was reduced by 53%, while the risk of disease progression or death was reduced by 55%.
Dr. Marjorie Green, of Merck Research Laboratories, highlighted the significance of this approval, as it offers patients a promising new first-line treatment option with potential life-extending benefits.
The approval encompasses all 27 EU member states, plus Iceland, Liechtenstein, Norway, and Northern Ireland. KEYTRUDA is now approved for three indications in bladder cancer in the EU, with a total of 28 approved indications overall.
Previously, KEYTRUDA was approved in the EU as a single-agent treatment for urothelial carcinoma patients who had received prior platinum-containing chemotherapy or were ineligible for such therapy. The approval was based on data from the KEYNOTE-045 and KEYNOTE-052 trials, respectively.
The combination of KEYTRUDA and enfortumab vedotin has also been approved in the U.S. for the treatment of locally advanced or metastatic urothelial cancer. Further research is ongoing with this combination as part of a comprehensive clinical development program.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.