RAHWAY, N.J. - Merck & Co., Inc., known as MSD outside the United States and Canada, has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for new indications of its anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in specific lung and urothelial cancers.
The approved indications include KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by KEYTRUDA as monotherapy for adjuvant treatment in patients with non-small cell lung carcinoma (NSCLC), based on results from the Phase 3 KEYNOTE-671 trial. This trial demonstrated a significant improvement in overall survival and event-free survival compared to the chemotherapy-placebo regimen.
Additionally, KEYTRUDA has been approved in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma. This approval is based on the Phase 3 KEYNOTE-A39 trial, which showed a significant improvement in overall survival and progression-free survival when compared to gemcitabine plus cisplatin or carboplatin.
For patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy, KEYTRUDA monotherapy has also been approved, based on the Phase 2 KEYNOTE-052 trial.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, expressed that these approvals address the unmet needs of patients with resectable NSCLC and radically unresectable urothelial carcinoma in Japan.
Lung cancer remains the leading cause of cancer death worldwide, with NSCLC accounting for about 85% of all cases. In Japan, the overall five-year survival rate for lung cancer patients is about 35%. Urothelial carcinoma, a type of bladder cancer, is estimated to affect 25,000 people in Japan annually.
KEYTRUDA is a humanized monoclonal antibody that works by increasing the body's immune system to detect and fight tumor cells. It is currently being studied in over 1,600 trials across various cancers and treatment settings.
This information is based on a press release statement from Merck & Co., Inc. and does not imply endorsement of KEYTRUDA's efficacy or safety. The full prescribing information for KEYTRUDA can be found on Merck's website.
In other recent news, Merck & Co. has introduced a new feline leukemia vaccine, NOBIVAC NXT FeLV, leveraging RNA-particle technology. The vaccine is expected to be available in veterinary clinics across the U.S. this fall. The company's KEYTRUDA therapy received positive opinions from the European Medicines Agency's Committee for gynecologic cancer indications, based on the outcomes of the Phase 3 NRG-GY018 and KEYNOTE-A18 trials. Moreover, the U.S. Food and Drug Administration approved KEYTRUDA for the treatment of advanced malignant pleural mesothelioma.
Merck's GARDASIL®9 HPV vaccine trial reported positive results, demonstrating efficacy in reducing the incidence of persistent anogenital infection. 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
Merck & Co., Inc. (NYSE:MRK), a global healthcare leader, has recently expanded the indications for its flagship immunotherapy drug, KEYTRUDA, in Japan. As investors digest the news of these approvals, it's crucial to consider the company's financial health and market performance to understand the potential impact on Merck's stock.
According to InvestingPro data, Merck boasts a robust market capitalization of $289.86 billion, underscoring its significant presence in the pharmaceutical industry. The company's Price/Earnings (P/E) ratio stands at 21.23, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at a lower 17.57, possibly reflecting investor confidence in its earnings potential. Merck has also demonstrated a solid revenue growth of 7.15% over the last twelve months as of Q2 2024, which could be indicative of its operational success and market expansion efforts like the recent KEYTRUDA approvals.
InvestingPro Tips highlight that Merck has raised its dividend for 13 consecutive years and has maintained dividend payments for 54 consecutive years, which could be a signal of the company's commitment to returning value to shareholders. Additionally, analysts predict that the company will be profitable this year, with Merck having been profitable over the last twelve months. These factors, combined with Merck's status as a prominent player in the Pharmaceuticals industry, could make it an attractive option for investors looking for stability in a volatile market.
For those interested in a deeper dive into Merck's financials and performance metrics, InvestingPro offers additional tips and insights. Currently, there are 9 more InvestingPro Tips available for Merck, which can be accessed through the InvestingPro platform at https://www.investing.com/pro/MRK.
The recent approvals of KEYTRUDA in Japan could further strengthen Merck's position in oncology treatment, potentially contributing to the company's revenue and profitability in upcoming quarters. Investors may keep an eye on the company's next earnings date on October 31, 2024, for updates on the financial impact of the expanded indications and Merck's overall performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.