Kenilworth, N.J.-based drugmaker Merck & Co. recently announced positive results from a late-stage study of its widely used cancer drug, Keytruda. The study focused on patients with high-risk, early breast cancer and aimed to evaluate Keytruda's effectiveness in combination with chemotherapy.
Keytruda successfully met its primary endpoint, which was the pathological-complete-response rate following the neoadjuvant part of the neoadjuvant/adjuvant regimen. This outcome is particularly promising for patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
Notably, this Phase 3 study marks the first time an immunotherapy-based regimen has demonstrated positive results in patients with high-risk, early-stage ER+/HER2- breast cancer.
While this primary endpoint has been achieved, the trial will continue to evaluate the second dual primary endpoint—event-free survival—without any changes.
Keytruda is a groundbreaking cancer drug that capitalizes on harnessing a patient's immune system to combat tumors. It has been extensively studied in multiple clinical trials across various cancer types and treatment settings. With its approval in numerous indications globally, Keytruda generated impressive sales of almost $21 billion in the previous year.
This study's encouraging results provide hope for breast cancer patients, and further investigations will ascertain Keytruda's potential in this specific population.