RAHWAY, N.J. - Merck (NS:PROR) & Co., Inc., operating as MSD outside the United States and Canada, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of its immunotherapy drug KEYTRUDA. The endorsement supports the use of KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, as a first-line treatment for adults with unresectable non-epithelioid malignant pleural mesothelioma ( MPM (BVMF:ESPA3)), a rare and aggressive cancer affecting the lining of the lungs.
The CHMP's recommendation is based on findings from the IND.227/KEYNOTE-483 trial, which showed that KEYTRUDA plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. The European Commission will review the CHMP's opinion for marketing authorization within the EU, with a final decision anticipated in the fourth quarter of 2024.
KEYTRUDA has already been approved in the U.S. for similar use, following the trial's demonstration of a 21% reduction in the risk of death and an increase in median OS to 17.3 months with the combination therapy, versus 16.1 months for chemotherapy alone. The treatment also improved progression-free survival (PFS) and overall response rate (ORR) significantly when compared to chemotherapy.
Malignant mesothelioma, which is often linked to asbestos exposure, is estimated to have caused over 25,000 deaths worldwide in 2022. The non-epithelioid form of the disease, which the CHMP's opinion addresses, is associated with poorer survival outcomes, underscoring the significance of the recommendation for patients in Europe.
KEYTRUDA, a humanized monoclonal antibody, works by enhancing the immune system's ability to detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, activating T lymphocytes that can target both tumor and healthy cells.
Merck maintains a robust immuno-oncology clinical research program, with over 1,600 trials studying KEYTRUDA across various cancers and treatment settings. The program aims to understand KEYTRUDA's role in cancer treatment and identify predictors of patient response, including the exploration of different biomarkers.
This news is based on a press release statement and has not been independently verified. The information provided does not include promotional content and is intended solely for reporting purposes.
In other recent news, Merck & Co. has been the subject of several noteworthy developments. The company's share target was raised to $148 by Jefferies, following Merck's strategic move to license a preclinical PD1xVEGF therapy from LaNova. This move is expected to bolster Merck's oncology portfolio and increase its competitiveness in the pharmaceutical market.
Concurrently, Merck, in collaboration with Alexion (NASDAQ:ALXN) and AstraZeneca (NASDAQ:AZN) Rare Disease, announced positive results from the Phase 3 KOMET trial of KOSELUGO in adults with neurofibromatosis type 1. The trial showed a significant improvement in the objective response rate, indicating the potential of KOSELUGO to positively impact patient care.
However, BMO Capital Markets revised its outlook on Merck, reducing the price target due to concerns over the Gardasil vaccine's performance in China. Leerink Partners maintained an Outperform rating on Merck's shares, acknowledging Gardasil as a central topic affecting investor sentiment.
Despite these challenges, Merck reported a 4% increase in third-quarter revenue for 2024, reaching $16.7 billion, driven by strong sales of its cancer drug KEYTRUDA and the introduction of WINREVAIR. These are among the recent developments shaping Merck's trajectory.
InvestingPro Insights
As Merck & Co. (MRK) receives positive news regarding its KEYTRUDA drug, investors may find additional context from InvestingPro data and tips valuable. The company's market capitalization stands at $248.81 billion, reflecting its significant presence in the pharmaceutical industry.
An InvestingPro Tip highlights that Merck is a prominent player in the Pharmaceuticals industry, which aligns with the company's ongoing development of innovative treatments like KEYTRUDA. This position is further supported by Merck's robust revenue of $63.17 billion over the last twelve months, with a 6.51% revenue growth rate.
Another relevant InvestingPro Tip notes that Merck has maintained dividend payments for 54 consecutive years, demonstrating financial stability even as it invests in groundbreaking therapies. The company's current dividend yield is 3.13%, which may be attractive to income-focused investors.
Merck's P/E ratio (adjusted) of 15.78 suggests that the stock may be reasonably valued relative to its earnings, especially considering the potential growth from treatments like KEYTRUDA. The company's gross profit margin of 76.59% indicates strong profitability in its product lineup.
For investors seeking more comprehensive analysis, InvestingPro offers additional tips and metrics. Currently, there are 13 more InvestingPro Tips available for Merck, providing deeper insights into the company's financial health and market position.
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