Merck & Co has received European Commission (EC) approval for the use of Keytruda (pembrolizumab) along with Padcev (enfortumab vedotin-ejfv) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma, a type of bladder cancer.
The authorisation follows the European Society for Medical Oncology and the European Association of Urology’s endorsement of this combination therapy as the preferred initial treatment for these patients, regardless of their eligibility for platinum-based chemotherapy.
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The EC’s decision is in line with the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024.
The recommendation was based on the data from the initial interim analysis of the Phase III KEYNOTE-A39 clinical trial, conducted in collaboration with Pfizer and Astellas.
The open-label, multicentre, randomised, active-controlled study compared KEYTRUDA plus enfortumab vedotin to platinum-based chemotherapy.
The combination showed statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS).
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By GlobalDataAt a median follow-up of 17.3 months, the combination therapy reduced the risk of death by 53% and disease progression or death by 55% versus platinum-based chemotherapy.
The approval enables the marketing of KEYTRUDA in combination with enfortumab vedotin for this indication across all 27 European Union member states, along with Liechtenstein, Iceland, Norway and Northern Ireland.
In December 2023, the combination therapy received approval in the US to treat locally advanced or metastatic urothelial cancer in adults.
Merck’s research laboratories oncology, global clinical development head and senior vice-president Dr Marjorie Green stated: “For the first time in decades, adult patients with unresectable or metastatic urothelial carcinoma have the option of a potential new first-line standard of care that may help extend their lives.
“We are pleased with the European Commission’s decision, and we look forward to being able to provide KEYTRUDA as part of this novel treatment regimen for this devastating disease to patients in the European Union.”
The development comes after the EC approved MSD’s Winrevair (sotatercept) to be used as a combination therapy for functional class II or III pulmonary arterial hypertension.
