Sun Sep 15 14:40:19 UTC 2024: ## Merck’s KEYTRUDA Shows Significant Survival Benefit for High-Risk Early-Stage Triple-Negative Breast Cancer
**RHAWAY, N.J. – September 15, 2024** – Merck (NYSE: MRK) today announced groundbreaking results from the Phase 3 KEYNOTE-522 trial, demonstrating a statistically significant improvement in overall survival (OS) for patients with high-risk early-stage triple-negative breast cancer (TNBC) treated with KEYTRUDA® (pembrolizumab).
The study, presented at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine, showed that the KEYTRUDA regimen, which included chemotherapy as pre-operative treatment followed by KEYTRUDA as a single agent after surgery, reduced the risk of death by 34% compared to the chemotherapy-placebo regimen.
This makes KEYTRUDA the first and only immunotherapy-based regimen to demonstrate a significant OS improvement in this patient population. The study followed patients for a median of 75.1 months, and the five-year OS rate was 86.6% for those treated with the KEYTRUDA regimen versus 81.7% for the chemotherapy-placebo group.
“These impactful overall survival results add to the previously reported pathological complete response and event-free survival data from the KEYNOTE-522 trial,” said Dr. Peter Schmid, lead of the Centre for Experimental Cancer Medicine at Barts Cancer Institute in London. “This study reinforces the important role this regimen plays in the treatment of high-risk early-stage TNBC.”
“This is an important milestone and represents the fourth KEYTRUDA study to demonstrate a significant overall survival benefit in an earlier stage of cancer,” said Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories. “This highlights our efforts to help extend the lives of patients with certain cancers across different stages of disease.”
The KEYNOTE-522 trial is one of four Phase 3 studies showing an OS benefit for KEYTRUDA-based regimens in earlier stages of cancer. This underscores Merck’s commitment to developing innovative therapies that can benefit patients at different stages of their cancer journey.
**About KEYTRUDA® (pembrolizumab)**
KEYTRUDA is an anti-PD-1 therapy that helps the body’s immune system fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, activating T lymphocytes, which may affect both tumor cells and healthy cells.
**About Triple-Negative Breast Cancer (TNBC)**
TNBC is the most aggressive type of breast cancer, with a high risk of recurrence and worse outcomes compared to other forms of breast cancer.
This latest KEYNOTE-522 data is a significant advancement in the treatment of high-risk early-stage TNBC, offering hope for improved survival rates and a better future for patients facing this challenging disease.
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