RAHWAY, N.J. - Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, has announced positive results from its Phase 3 KEYNOTE-A18 trial, which demonstrated a significant improvement in overall survival (OS) for patients with high-risk locally advanced cervical cancer when treated with KEYTRUDA, an anti-PD-1 therapy, in combination with chemoradiotherapy (CRT).
The independent Data Monitoring Committee's pre-specified interim analysis revealed that the combination of KEYTRUDA and CRT led to a statistically significant and clinically meaningful enhancement in OS compared to CRT alone. The safety profile of KEYTRUDA was consistent with previous studies, and no new safety concerns were identified.
The KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, previously met its other primary endpoint of progression-free survival (PFS) in 2023. These findings, presented at the European Society for Medical Oncology (ESMO) Congress 2023, supported the U.S. Food and Drug Administration's approval of KEYTRUDA in combination with CRT for treating patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer in January 2024.
Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, commented on the significance of these results, emphasizing Merck's commitment to exploring KEYTRUDA's role across various cancer types at earlier disease stages. Prof. Domenica Lorusso, the study's overall principal investigator, echoed the importance of these findings for patients with locally advanced cervical cancer.
In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1, and as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.
The KEYNOTE-A18 trial enrolled 1,060 patients and compared KEYTRUDA plus CRT against placebo plus CRT. Results from the trial will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
Cervical cancer is the fourth most common cancer in women globally, with an estimated 13,820 new cases and approximately 4,360 deaths expected in the U.S. in 2024.
This news is based on a press release statement from Merck & Co., Inc.
InvestingPro Insights
Following the positive news from Merck & Co.'s latest KEYNOTE-A18 trial, investors and stakeholders may be interested in the company's financial health and market position. Merck, with a substantial market capitalization of $305.21 billion, remains a heavyweight in the pharmaceutical industry. The company's commitment to innovation and expanding the applications of KEYTRUDA is reflected in its performance metrics and strategic positioning.
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