RAHWAY, N.J. - Merck & Co., Inc., known as MSD outside the United States and Canada, has reached a pivotal milestone with its anti-PD-1 therapy, KEYTRUDA. The Phase 3 KEYNOTE-522 trial showed a statistically significant improvement in overall survival (OS) for patients with high-risk early-stage triple-negative breast cancer (TNBC) when treated with KEYTRUDA in combination with chemotherapy, followed by KEYTRUDA as a single agent after surgery, compared to pre-operative chemotherapy alone.
This marks the first instance where an immunotherapy-based regimen has demonstrated a significant OS benefit in this patient group. The safety profile of KEYTRUDA was consistent with previous studies, with no new safety signals observed. These findings will be presented at an upcoming medical meeting and submitted to regulatory authorities.
TNBC is a particularly aggressive form of breast cancer, accounting for approximately 10-15% of all breast cancers. It is more likely to affect younger individuals, Black individuals, or those with a BRCA1 mutation. The absence of estrogen and progesterone receptors and human epidermal growth factor receptor 2 (HER2) in TNBC makes it unresponsive to some of the most common treatments available for breast cancer, underscoring the significance of this trial's results.
KEYTRUDA currently has two approved indications for TNBC in the U.S. and is part of a comprehensive clinical development program by Merck to explore treatments for various subtypes of breast cancer. The KEYNOTE-522 trial, which enrolled 1,174 patients, is among several studies evaluating KEYTRUDA's potential in earlier stages of cancer and in combination with other therapies.
Merck's research efforts in oncology include more than 20 Phase 3 studies and an extensive immuno-oncology clinical research program, reflecting the company's commitment to advancing science and improving patient outcomes in cancer care.
The information is based on a press release statement from Merck & Co., Inc.
InvestingPro Insights
As Merck & Co., Inc. (NYSE: MRK) continues to make significant strides in the oncology space with its KEYTRUDA therapy, investors are closely watching the company's financial health and market performance. According to InvestingPro data, Merck boasts a robust market capitalization of $327.97 billion, reflecting its strong position in the pharmaceutical industry. The company's commitment to innovation and patient care is also evident in its financial metrics, with a revenue growth of 8.89% in Q1 2024, indicating a solid upward trajectory in its business operations.
InvestingPro Tips highlight the company's stability and potential for growth, noting that Merck has raised its dividend for 13 consecutive years and maintains a dividend yield of 2.38%. This consistent return to shareholders is supported by a dividend growth rate of 5.48% over the last twelve months as of Q1 2024. Moreover, Merck's prominence as a key player in the Pharmaceuticals industry is further solidified by its ability to cover interest payments with its cash flows, showcasing financial resilience.
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