RAHWAY, N.J. - The European Commission (EC) has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. This decision aligns with clinical guidelines from the European Society for Medical Oncology and the European Association of Urology, which recommend the combination as the preferred initial treatment for these patients, regardless of their eligibility for platinum-based chemotherapy.
This approval is based on the Phase 3 KEYNOTE-A39 trial results, which showed significant improvements in overall survival (OS) and progression-free survival (PFS) over platinum-based chemotherapy. Specifically, the KEYTRUDA plus enfortumab vedotin regimen reduced the risk of death by 53% and the risk of disease progression or death by 55% when compared to the chemotherapy group.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, at Merck Research Laboratories, expressed optimism about providing this new treatment option in the European Union, which may extend the lives of patients with this devastating disease.
The approval permits marketing of the combination treatment across all 27 EU member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. This marks the third bladder cancer indication for KEYTRUDA in the EU and its 28th overall.
Merck, in collaboration with Pfizer (NYSE:PFE) and Astellas, is evaluating the combination in an extensive clinical development program for multiple stages of urothelial cancer, including two Phase 3 trials in muscle-invasive bladder cancer.
KEYTRUDA works by enhancing the body's immune system's ability to detect and fight tumor cells. It is part of the industry's largest immuno-oncology clinical research program, which includes more than 1,600 trials across various cancers and treatment settings.
Bladder cancer, specifically urothelial carcinoma, is one of the most common cancers globally, with an estimated 614,300 new cases annually. In Europe, around 166,000 new cases were expected in 2022, and in the U.S., approximately 83,200 people are projected to be diagnosed in 2024. Advanced urothelial carcinoma at diagnosis has a poor prognosis for many patients.
The collaboration between Astellas, Pfizer (formerly Seagen), and Merck aims to explore the potential of the KEYTRUDA and enfortumab vedotin combination for patients with previously untreated metastatic urothelial cancer.
Merck's commitment to oncology research is reflected in its pursuit of breakthrough science to shape the future of the field and its efforts to reduce disparities in clinical trial participation, screening, and treatment access.
This article is based on a press release statement.
In other recent news, Merck & Co. has reported a series of significant developments. The pharmaceutical giant announced the discontinuation of two Phase 3 clinical trials, KEYNOTE-867 and KEYNOTE-630, due to insufficient efficacy of its anti-PD-1 therapy, KEYTRUDA, in treating non-small cell lung cancer and cutaneous squamous cell carcinoma. On the other hand, Merck has launched a Phase 3 trial for bomedemstat, a drug aimed at treating essential thrombocythemia, a rare blood disorder. In a noteworthy business move, Merck acquired CN201, a clinical-stage bispecific antibody, from Curon Biopharmaceutical for $700 million.
The European Commission has also approved Merck's therapy, WINREVAIR, for the treatment of pulmonary arterial hypertension. This marks the first activin signaling inhibitor therapy in the European Union. Furthermore, the company's second-quarter results for 2024 surpassed market expectations, with significant organic sales growth in its CM&E and oncology franchises within the Healthcare sector, and in its Electronics division. Merck upgraded its full-year 2024 guidance, expecting net sales between €20.7 billion to €22.1 billion.
In related news, the Biden administration has initiated price negotiations with the Medicare health program for 10 prescription medicines, including Merck's Januvia. These negotiations are expected to save the U.S. government $6 billion in the first year. These are the most recent developments for Merck & Co.
InvestingPro Insights
In light of the European Commission's approval of KEYTRUDA, Merck's financial stability and growth prospects are noteworthy. InvestingPro data shows Merck & Co. (MRK) with a robust market capitalization of $300.25 billion, underscoring the company's significant presence in the pharmaceutical industry. The company's Price/Earnings (P/E) ratio stands at 21.77, reflecting investor expectations of future earnings potential, which aligns with the InvestingPro Tip that net income is expected to grow this year. This anticipated growth in net income may be partially attributed to new approvals and the expansion of treatments like KEYTRUDA.
Merck's commitment to oncology and its expansive clinical research program is supported by a strong financial backbone, with a Gross Profit Margin of 75.79% over the last twelve months as of Q2 2024. This high margin indicates the company's ability to manage production and operational costs effectively while investing in research and development. Additionally, the company's dividend history is impressive, as it has raised its dividend for 13 consecutive years and maintained dividend payments for 54 consecutive years, as per another InvestingPro Tip. This suggests a reliable return to investors, which could be attractive to those looking for stable income in their portfolios.
For readers interested in a deeper analysis, there are 16 additional InvestingPro Tips available for Merck & Co. These tips provide further insights into the company's financial health, stock performance, and industry standing, which can help investors make more informed decisions. For instance, knowing that Merck operates with a moderate level of debt and that its cash flows can sufficiently cover interest payments could reassure investors of the company's financial prudence.
Investors and stakeholders following Merck's progression in the pharmaceutical industry, particularly in the oncology sector, may find these InvestingPro Insights valuable for understanding the company's financial context in relation to its clinical advancements.
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