(Credit: Merck & Co., Inc.)
The European Commission has approved Merck & Co.’s Keytruda anti-PD-1 therapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection.
This approval is based on data from the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial, conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC).
An updated recurrence-free survival data analysis, conducted at the request of the European Medicines Agency, demonstrated that Keytruda significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 44 percent compared to placebo in the overall population of patients with resected, high-risk stage III melanoma (HR=0.56; 98% CI, 0.44-0.72; p<0.0001).
“Merck’s long-term commitment to melanoma patients includes a particular focus on bringing new treatment options to these patients earlier in the treatment paradigm,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “This approval, which is the first for Keytruda in the adjuvant setting in the European Union, builds upon the foundation established by Keytruda in the advanced and metastatic melanoma settings.”
The approval allows marketing of Keytruda in this new indication in all 28 EU member states plus Iceland, Lichtenstein, and Norway, at the approved dose of 200 mg every three weeks until disease recurrence, unacceptable toxicity, or for a duration of up to one year.
Keytruda is also approved in Europe as a monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
“Melanoma patients, particularly those with stage III disease, often have a high risk of recurrence, and the collaborative study from EORTC and Merck demonstrated a significant reduction in the risk of cancer returning after surgery,” said Dr. Alexander Eggermont, study chair, director general at the Gustave Roussy Cancer Institute, Professor of Oncology, University of Paris-Saclay. “This approval in the adjuvant setting marks another important milestone in the treatment of melanoma.”
Merck is known as MSD outside the United States and Canada.
(Source: Merck & Co., Inc.)
Filed Under: Oncology
