RAHWAY, N.J. - Merck & Co., Inc., a global healthcare leader, reported that its Phase 3 KEYFORM-007 clinical trial did not meet the primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The trial evaluated the efficacy of a fixed-dose combination of favezelimab, an anti-LAG-3 antibody, and pembrolizumab, Merck's anti-PD-1 therapy, compared to the standard of care.
The final pre-specified analysis concluded that the combination of favezelimab and pembrolizumab did not improve overall survival versus standard treatments, regorafenib or TAS-102. Despite this outcome, the safety profile of the combination therapy was consistent with previous studies, showing no new safety concerns.
Dr. M. Catherine Pietanza, vice president of global clinical development at Merck Research Laboratories, expressed gratitude to the participants and investigators involved in the study. She emphasized the company's commitment to continuing the development of KEYTRUDA-based combinations and novel candidates for patients with colorectal cancer who require new treatment options.
Colorectal cancer remains the third most commonly diagnosed cancer worldwide, with microsatellite stable disease being particularly challenging to treat due to its limited response to immunotherapies. In the United States, KEYTRUDA is currently approved for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer as determined by an FDA-approved test, but not for MSS mCRC.
The fixed-dose combination of favezelimab and pembrolizumab is also under investigation for various solid tumor types and certain hematologic malignancies, including a Phase 3 study for patients with relapsed or refractory classical Hodgkin lymphoma.
The KEYFORM-007 trial enrolled 441 patients who were randomized to receive either the fixed-dose combination or the investigator's choice of standard care. Merck plans to fully evaluate the data and share the findings with the scientific community.
This announcement is based on a press release statement from Merck & Co., Inc.
In other recent news, Merck & Co., Inc. has made significant strides in the healthcare sector. The company's KEYTRUDA therapy received new approvals from the Japanese Ministry of Health, Labor and Welfare for specific lung and urothelial cancers, addressing unmet needs in these areas. Additionally, Merck launched a new feline leukemia vaccine, NOBIVAC NXT FeLV, which will be available in veterinary clinics across the U.S. soon.
Merck's KEYTRUDA therapy also gained positive opinions from the European Medicines Agency's Committee for gynecologic cancer indications, and the U.S. Food and Drug Administration approved KEYTRUDA for the treatment of advanced malignant pleural mesothelioma. These approvals are based on the results of various Phase 3 trials.
In terms of analyst notes, BMO Capital Markets maintained its Outperform rating on Merck, based on the strong performance of Merck's investigational therapy, ivonescimab. In legal developments, a lawsuit challenging a U.S. statute that mandates pharmaceutical companies, including Merck, to discuss drug prices with Medicare was revived by the 5th U.S. Circuit Court of Appeals. These recent developments provide a snapshot of Merck & Co.'s ongoing operations and achievements.
InvestingPro Insights
As Merck & Co., Inc. navigates the challenges of clinical trial outcomes, the company's financial health remains a focal point for investors. According to InvestingPro data, Merck boasts a robust market capitalization of $289.86 billion, reflecting its significant presence in the pharmaceutical industry. The company's P/E ratio stands at 21.23, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at 17.57, indicating a favorable valuation relative to earnings.
InvestingPro Tips suggest Merck is a company with a history of financial stability and shareholder returns. The company has raised its dividend for 13 consecutive years and has maintained dividend payments for an impressive 54 consecutive years, underscoring its commitment to returning value to shareholders. Additionally, analysts predict the company will be profitable this year, as evidenced by its profitability over the last twelve months.
Investors may find reassurance in Merck's low price volatility and its position as a prominent player in the Pharmaceuticals industry. For those looking to explore further, there are additional InvestingPro Tips available at InvestingPro, providing deeper insights into Merck's financial metrics and market performance.
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