Merck & Co., has shared new findings from its Phase 3 KEYNOTE-522 trial, showing that its immunotherapy drug KEYTRUDA, when combined with chemotherapy, can significantly improve survival in patients with high-risk early-stage triple-negative breast cancer (TNBC). The results were presented at the European Society for Medical Oncology Congress 2024 and published in the New England Journal of Medicine.
The study, which followed patients for a median of just over six years, revealed that the group treated with the KEYTRUDA regimen had a 34% lower risk of death compared to those who received chemotherapy and a placebo. Five years into the study, 86.6% of patients in the KEYTRUDA group were still alive, compared to 81.7% in the placebo group.
Dr. Peter Schmid, the lead investigator from Barts Cancer Institute in London, noted the significance of the findings, stating that adding pembrolizumab (KEYTRUDA) to chemotherapy before surgery, and continuing with it after surgery, reduced the risk of death by more than a third. “These results reinforce the importance of this treatment for patients with high-risk early-stage TNBC,” he said.
KEYTRUDA is the first immunotherapy-based treatment shown to improve overall survival in this patient group, offering a new hope for individuals dealing with this aggressive form of cancer.
The findings build on earlier data from the same trial that showed improvements in event-free survival and response to treatment. Based on this earlier data, KEYTRUDA is already approved in several countries, including the U.S. and Europe, for treating high-risk early-stage TNBC.