RAHWAY, N.J. - Merck & Co., Inc., a leading pharmaceutical company, announced positive results from the Phase 3 KEYNOTE-811 trial of its anti-PD-1 therapy, KEYTRUDA. The trial met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The KEYTRUDA combination therapy, which includes trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, demonstrated a statistically significant improvement in OS compared to the placebo combination in the intention-to-treat population. This benefit was most pronounced in patients whose tumors expressed PD-L1. The safety profile of KEYTRUDA was consistent with previous studies, with no new safety concerns identified.
These findings are particularly significant given the poor prognosis typically associated with advanced gastric cancer, where the five-year survival rate for patients diagnosed at an advanced stage is only 7%. Dr. Marjorie Green, senior vice president and head of oncology global clinical development at Merck Research Laboratories, emphasized the importance of treatment options that can extend patients' lives.
The U.S. Food and Drug Administration (FDA) had previously granted accelerated approval for KEYTRUDA in this patient population based on the objective response rate and durability of response shown in earlier analyses. The continued approval may hinge on further verification and description of clinical benefits from the final analysis of the KEYNOTE-811 study.
Merck plans to present detailed results at an upcoming medical meeting and will share the data with regulatory authorities worldwide. The company has a broad clinical development program for KEYTRUDA, evaluating its use in various gastrointestinal cancers and other types.
The KEYNOTE-811 trial enrolled 698 patients and is part of Merck's extensive research efforts to improve cancer treatments through immunotherapy. KEYTRUDA works by enhancing the body's immune system to detect and fight tumor cells. It is currently being studied across various types of cancer in more than 1,600 trials.
This announcement is based on a press release statement from Merck & Co., Inc.
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Merck & Co., Inc. (NYSE: MRK), a pharmaceutical giant, has shown promising results from its KEYTRUDA clinical trials, which could have a significant impact on its future revenue and market position. According to InvestingPro data, Merck boasts a robust market capitalization of $327.32 billion, reflecting investor confidence in its long-term strategy and innovation pipeline. With a Price to Earnings (P/E) ratio of 86.69 for the last twelve months as of Q1 2024, the company trades at a high earnings multiple, possibly indicating market expectations of strong future earnings growth.
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