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FDA approves KEYTRUDA for advanced malignant pleural mesothelioma

Published 09/18/2024, 06:54 PM
MRK
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RAHWAY, N.J. - Merck & Co., Inc., a leading pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its immunotherapy drug KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, for the treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).


This approval is grounded on the results from the Phase 3 IND.227/KEYNOTE-483 trial, which showed that KEYTRUDA plus chemotherapy improved overall survival, reducing the risk of death by 21% compared to chemotherapy alone. The median overall survival was reported as 17.3 months for the KEYTRUDA combination versus 16.1 months for chemotherapy alone.


The trial also indicated a significant improvement in progression-free survival and overall response rate for patients treated with KEYTRUDA in combination with chemotherapy. Adverse reactions for MPM patients were consistent with those experienced by other patients receiving the same combination therapy.


Dr. Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, expressed that this approval offers a new first-line treatment option for patients with a generally poor prognosis and underscores Merck's commitment to advancing research for patients with challenging tumors.


The Phase 3 component of the IND.227/KEYNOTE-483 trial enrolled 440 patients, regardless of tumor PD-L1 expression, who had not undergone prior systemic therapy for advanced/metastatic disease. The trial was sponsored and conducted by CCTG in collaboration with NCIN and IFCT, with Merck providing KEYTRUDA and support for the trial.


MPM is a rare but aggressive cancer that originates in the lining of the lungs and has a low five-year survival rate. KEYTRUDA is an anti-PD-1 therapy that boosts the body's immune system to detect and combat tumor cells.


Despite the positive results, KEYTRUDA can cause severe or fatal immune-mediated adverse reactions in any organ system at any time during or after treatment. Based on its mechanism of action, KEYTRUDA can also cause fetal harm when administered to a pregnant woman.


This approval marks the first indication for KEYTRUDA in MPM in the U.S., expanding the treatment options for patients with this challenging disease. The information is based on a press release statement from Merck & Co., Inc.


In other recent news, Merck & Co. has had several key developments. The healthcare company reported positive results for its GARDASIL®9 HPV vaccine trial, meeting both primary and secondary endpoints. Also, Merck's second-quarter results for 2024 exceeded market expectations, displaying substantial growth in its CM&E and oncology franchises, leading to an upward revision of its full-year 2024 guidance. Analyst firm TD Cowen maintained a Buy rating on Merck, indicating confidence in the company's potential for growth.


Merck has also been active in clinical trials, notably initiating the BRUNELLO trial for its investigational drug Restoret (MK-3000), aimed at treating diabetic macular edema. However, two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, were halted due to insufficient efficacy of KEYTRUDA in treating non-small cell lung cancer and cutaneous squamous cell carcinoma.


The European Commission approved Merck's anti-PD-1 therapy KEYTRUDA, in combination with Padcev, for the treatment of unresectable or metastatic urothelial carcinoma. This marks the third bladder cancer indication for KEYTRUDA in the EU. Additionally, the European Commission approved Merck's therapy, WINREVAIR, for the treatment of pulmonary arterial hypertension.


Lastly, the Biden administration initiated price negotiations with the Medicare health program for 10 prescription medicines, including Merck's Januvia, which are expected to save the U.S. government $6 billion in the first year. These are some of the recent developments concerning Merck & Co.


InvestingPro Insights


As Merck & Co., Inc. (NYSE: MRK) garners attention with the FDA approval of its immunotherapy drug KEYTRUDA for malignant pleural mesothelioma, investors and stakeholders may be curious about the company's financial health and stock performance. Recent data from InvestingPro provides a snapshot of Merck's market standing and potential outlook:



  • The company boasts a robust market capitalization of $299.84 billion, reflecting its significant presence in the pharmaceutical industry.

  • Merck's Price-to-Earnings (P/E) ratio stands at 21.77, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at 18.07, indicating investor expectations for future earnings.

  • With a dividend yield of 2.6% as of the latest data, Merck continues to reward shareholders, maintaining dividend payments for an impressive 54 consecutive years, as highlighted by one of the InvestingPro Tips.


InvestingPro Tips also underscore Merck's expected net income growth this year and its status as a prominent player in the Pharmaceuticals industry. Additionally, the company's stock is known for low price volatility, making it a potentially attractive option for investors seeking stability.


For those looking to delve deeper into Merck's investment potential, InvestingPro offers a comprehensive list of tips, including insights on the company's moderate level of debt and its ability to cover interest payments comfortably with its cash flows. There are 10 additional tips listed on InvestingPro, which can be accessed for further detailed analysis and investment considerations.


As Merck expands its treatment options with KEYTRUDA, these financial metrics and InvestingPro Tips may prove valuable for investors assessing the company's future prospects in light of its recent clinical advancements.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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