Merck & Co. recently announced that its cancer drug, Keytruda, has successfully met the second primary endpoint in a Phase 3 study. The study focused on using Keytruda as a perioperative treatment for patients with non-small cell lung cancer, specifically those with resectable stage II, IIIA, or IIIB.
Keytruda, when combined with chemotherapy before surgery, followed by resection and Keytruda as a single agent after surgery, demonstrated a significant improvement in overall survival. The results were both statistically significant and clinically meaningful.
It is worth noting that a perioperative treatment regimen involves treatment before and after surgery. In March, Merck reported that the study had already met its primary endpoint of improvement in event-free survival.
Currently, the U.S. Food and Drug Administration is reviewing Merck’s application to expand the approval of Keytruda for this new indication. The target action date is set for October 16.
Non-small cell lung cancer is the leading cause of cancer-related death globally, accounting for over 80% of all cases.
Merck has been dedicated to studying the efficacy of Keytruda across multiple cancers and treatment settings. This cancer drug utilizes a patient’s immune system to fight tumors. With approvals in numerous indications worldwide, Keytruda has generated over $12 billion in sales in the first half of 2023 alone.