Merck (known as MSD outside the U.S. and Canada) has received approval from the European Commission (EC) for KEYTRUDA, its anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) at high risk of recurrence after complete resection and platinum-based chemotherapy. This approval was granted following a positive recommendation from the Committee for Medicinal Products for Human Use based on results from the Phase 3 KEYNOTE-091 trial. KEYTRUDA demonstrated a significant 24% risk reduction in disease recurrence or death at a median follow-up time of 46.7 months. At an earlier analysis, it showed a statistically significant and clinically meaningful improvement in disease-free survival in the overall patient population.
Dr. Solange Peters, Chair of the Medical Oncology and Thoracic Malignancies Department in Switzerland emphasized the importance of this approval, as it provides the first immunotherapy option for high-risk NSCLC patients post-surgery and chemotherapy, irrespective of PD-L1 expression. This approval allows the marketing of KEYTRUDA in 27 EU member states, along with Iceland, Liechtenstein, Norway, and Northern Ireland. Dr. Gregory Lubiniecki, Vice President of Global Clinical Development at Merck Research Laboratories, highlighted the significant progress in treating various stages of lung cancer in Europe with KEYTRUDA, which now has five approved indications for NSCLC.
The approval of KEYTRUDA for high-risk NSCLC addresses an unmet medical need by potentially improving treatment outcomes for patients who have already undergone surgery and chemotherapy. It signifies a vital addition to the available therapeutic options and offers hope to those facing the risk of NSCLC recurrence after initial treatment. This decision reinforces the role of immunotherapy in early-stage NSCLC and underscores the commitment to advancing lung cancer treatment.
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