RAHWAY, N.J. - Merck, known as MSD outside the United States and Canada, has received approval from the European Commission (EC) for two new indications of its anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), to treat certain gynecologic cancers. The first approval is for the use of KEYTRUDA in combination with chemotherapy for the first-line treatment of primary advanced or recurrent endometrial carcinoma. The second is for KEYTRUDA combined with chemoradiotherapy for the treatment of locally advanced cervical cancer.
The approvals were granted based on the results of Phase 3 trials, which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for the specified patient groups. Specifically, the NRG-GY018/KEYNOTE-868 trial showed that KEYTRUDA, with chemotherapy, followed by KEYTRUDA as a single agent, improved PFS in patients with endometrial carcinoma. The KEYNOTE-A18 trial found that KEYTRUDA combined with concurrent chemoradiotherapy significantly improved OS and PFS in newly diagnosed patients with locally advanced cervical cancer.
These new treatment options have the potential to alter the standard of care for women with these types of cancer in Europe. Endometrial and cervical cancers are among the most common cancers affecting women in Europe, with significant annual diagnosis and mortality rates.
The EC's decision allows for the marketing of these KEYTRUDA regimens in all 27 EU member states, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland. The availability of KEYTRUDA for these indications will vary by country, depending on national reimbursement procedures.
Merck's research in women's cancers aims to improve outcomes for patients by expanding treatment options for breast and gynecologic cancers. The company is conducting over 20 clinical trials with more than 18,000 patients worldwide, focusing on novel mechanisms and combinations to advance the standard of care.
KEYTRUDA is a humanized monoclonal antibody that enhances the body's immune system to detect and fight tumor cells. It is now approved for 30 indications in the EU, including five in gynecologic cancers, demonstrating its growing role in cancer treatment across diverse patient populations and settings.
The information in this article is based on a press release statement from Merck & Co., Inc.
In other recent news, Merck has been actively expanding its oncology portfolio and advancing its clinical trials. The pharmaceutical giant recently acquired Modifi Biosciences, a cancer therapy development company, in a deal potentially worth up to $1.3 billion. This acquisition is geared towards the development of novel cancer therapies known as KL-50, which are currently in the pre-clinical stage and are being investigated for their potential to treat challenging brain tumors.
Moreover, Merck announced positive results from the STRIDE-8 Phase 3 trial of its pneumococcal 21-valent conjugate vaccine, CAPVAXIVE. The vaccine showed a favorable safety profile and was found to be immunogenic across all 21 serotypes in adults with chronic conditions.
In a strategic collaboration with Exelixis (NASDAQ:EXEL), Merck is working on the evaluation of Exelixis' investigational drug zanzalintinib in combination with Merck's anti-PD-1 therapy KEYTRUDA. Truist Securities maintained a Buy rating on Exelixis, expressing confidence in zanzalintinib's potential and the collaboration's potential to increase revenue for Exelixis.
Finally, Truist Securities revised its price target for Merck from $143.00 to $132.00, following the acquisition of CN201 from Curon Biopharmaceutical and an increase in projected research and development expenses. These are the recent developments in Merck's operations.
InvestingPro Insights
Merck's recent European Commission approvals for KEYTRUDA in treating gynecologic cancers align with the company's strong market position and financial health. According to InvestingPro data, Merck boasts a substantial market capitalization of $269.65 billion, underlining its significance in the pharmaceutical industry.
An InvestingPro Tip highlights that Merck is a prominent player in the Pharmaceuticals industry, which is evident from its continued innovation and expansion of KEYTRUDA's indications. This aligns with the company's robust revenue of $62.48 billion over the last twelve months, with a notable revenue growth of 7.15% during the same period.
The company's financial stability is further reflected in its ability to maintain dividend payments for 54 consecutive years, as noted in another InvestingPro Tip. This consistency in shareholder returns, coupled with a current dividend yield of 2.9%, may appeal to investors looking for stable income alongside potential growth from breakthrough treatments like KEYTRUDA.
Merck's strong gross profit margin of 75.79% suggests efficient cost management, which is crucial for funding extensive clinical trials and research initiatives mentioned in the article. This financial strength positions Merck well to continue its ambitious research program in women's cancers and other areas.
For readers interested in a deeper financial analysis of Merck, InvestingPro offers 12 additional tips and a range of real-time metrics to inform investment decisions.
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