The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approving MSD’s KEYTRUDA, along with Padcev (enfortumab vedotin-ejfv), as first-line treatment for urothelial carcinoma.
The combination regimen is intended for use in adults with unresectable or metastatic urothelial carcinoma.
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KEYTRUDA is an anti-programmed death cell protein-1 therapy. Padcev is an antibody-drug conjugate.
CHMP’s positive opinion is based on the interim data from the Phase III KEYNOTE-A39 clinical trial.
The trial, a collaborative effort between MSD, Pfizer and Astellas, showed that the combination therapy significantly improved overall survival and progression-free survival compared to platinum-based chemotherapy.
The KEYTRUDA plus Padcev regimen also lowered the mortality risk by 53% and the risk of disease progression or death by 55% compared to the standard platinum-based chemotherapy.
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By GlobalDataThe European Commission will now review the CHMP’s recommendation for marketing authorisation within the European Union, with a final decision expected by the third quarter of 2024.
KEYTRUDA was previously approved in the EU as a monotherapy for certain types of urothelial carcinoma The KEYTRUDA plus Padcev combination was approved in the US in December 2023.
MSD, along with Pfizer and Astellas, continues to evaluate the KEYTRUDA and Padcev combination as part of a comprehensive clinical development programme.
This includes two additional Phase III clinical trials, KEYNOTE-B15 and KEYNOTE-905, focusing on muscle-invasive bladder cancer.
Merck Research Laboratories global clinical development senior vice-president and head and chief medical officer Dr Eliav Barr stated: “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.
“We look forward to the European Commission’s decision and are excited to be taking the first steps to provide a potential new first-line standard of care for the treatment of this disease in patients in the EU.”
The latest development comes after MSD acquired Eyebiotech (EyeBio), making the company its subsidiary.
