RAHWAY, N.J. & NUTLEY, N.J. – Merck (NSE:) & Co., Inc. (NYSE:) and Eisai Co., Ltd. (TYO:) have announced the latest outcomes from their Phase 3 LEAP-015 trial, which evaluated the efficacy of the combination therapy KEYTRUDA and LENVIMA for patients with advanced gastroesophageal adenocarcinoma. The combination therapy showed a statistically significant improvement in progression-free survival and objective response rate compared to standard chemotherapy. However, it did not achieve a meaningful increase in overall survival.
The trial’s dual primary endpoints were progression-free survival (PFS) and overall survival (OS), with objective response rate (ORR) as a key secondary endpoint. The safety profile of the regimen was consistent with previous studies of the combination. With revenue growth of 6.5% and robust cash flows, Merck maintains strong financial capability to advance its clinical research programs. For detailed analysis of Merck’s research pipeline and financial metrics, InvestingPro subscribers have access to comprehensive research reports and 12+ additional ProTips.
Gastroesophageal adenocarcinoma is a significant challenge in cancer treatment due to its complexity and poor prognosis. The LEAP-015 trial’s findings contribute to the broader understanding of potential treatments, despite not meeting the primary endpoint of OS improvement. Merck and Eisai plan to present the full data at an upcoming medical meeting.
KEYTRUDA plus LENVIMA is currently approved in the U.S., EU, Japan, and other countries for the treatment of specific types of advanced renal cell carcinoma and endometrial carcinoma. The LEAP clinical program continues to explore the combination’s effectiveness in various cancers, including hepatocellular carcinoma and esophageal cancer.
The results from the LEAP-015 trial do not affect the current approved indications for KEYTRUDA plus LENVIMA or other ongoing trials within the LEAP clinical program.
Gastric and gastroesophageal cancers are among the top causes of cancer-related deaths globally, with low five-year survival rates for advanced-stage diagnoses. The LEAP-015 trial aimed to address the unmet medical needs of this patient population.
This news is based on a press release statement and reflects the ongoing commitment of Merck and Eisai to advance cancer research and treatment options. Trading near its 52-week low, Merck maintains a strong financial position with moderate debt levels and consistent dividend payments. Access the complete financial health analysis and Fair Value estimates through InvestingPro‘s detailed research reports, available for 1,400+ top stocks.
In other recent news, Merck & Co., Inc. reported a 4% increase in third-quarter revenue for 2024, reaching $16.7 billion, due to robust sales of its cancer drug, KEYTRUDA, and the introduction of WINREVAIR. The company also secured an exclusive global licensing agreement with LaNova Medicines Ltd. for LM-299, a novel cancer therapy. Meanwhile, Guggenheim Securities adjusted its outlook on Merck shares, reducing the price target from $130.00 to $122.00 while reaffirming a Buy rating. This revision is primarily due to several updates to the firm’s financial model for Merck, including revised revenue forecasts for several of Merck’s products.
In addition, the National Medical (TASE:) Products Administration of China approved the use of GARDASIL® for males aged 9 to 26, marking it as the first HPV-prevention vaccine for males in the country. Analyst firms, including BMO Capital Markets and Bernstein, have adjusted their ratings on Merck’s stock, citing various reasons such as concerns over the performance of its Gardasil franchise in China and potential challenges for its cancer drug Keytruda.
These are recent developments in the pharmaceutical industry and Merck’s operations, reflecting the company’s commitment to expanding its research and development pipeline and addressing unmet medical needs.
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