Merck (MSD), a global pharmaceutical company, has received a positive opinion from the European Medicines Agency regarding the approval of Keytruda plus Padcev to treat metastatic urothelial carcinoma.
The opinion from the Committee for Medicinal Products for Human Use (CHMP) follows the results of the pivotal Phase III KEYNOTE-A39 trial, which assessed the efficacy of the anti-PD-1 therapy in combination with Padcev, an antibody-drug conjugate (ADC).
Patient OS and PFS significantly improved
The trial was conducted in collaboration with Pfizer and Astellas, with Keytruda plus enfortumab vedotin significantly improving overall survival (OS) and progression-free survival (PFS) rates versus platinum-based chemotherapy.
The combination diminished the risk of death by 53% when compared to chemotherapy, while reducing the risk of disease progression by 55%.
The European Commission will now review Keytruda plus Padcev for marketing authorisation in the European Union — with the final decision likely to be published later in 2024.
“The CHMP’s positive opinion reinforces the landmark results from KEYNOTE-A39 and follows the recent adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending KEYTRUDA plus enfortumab vedotin as the preferred first-line treatment for patients with advanced or metastatic urothelial carcinoma, regardless of platinum eligibility,” said Dr Eliav Barr, Senior Vice President and Head of global clinical development, Chief Medical Officer, Merck Research Laboratories.
Keytruda has been approved in the EU as a monotherapy to treat metastatic urothelial carcinoma in adults who have previously received platinum chemotherapies, as well as those who are ineligible for such treatment modalities.
[Image credit: Merck Laboratories]