CAMBRIDGE, MA and RAHWAY, NJ - Moderna , Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK) have recently announced results from their Phase 2b clinical trial, indicating that the combination of mRNA-4157 (V940) with KEYTRUDA (pembrolizumab) significantly reduced the risk of recurrence or death in patients with high-risk melanoma. The study, which followed participants for a median of nearly three years, showed a 49% reduction in risk compared to KEYTRUDA alone.
The trial, known as KEYNOTE-942/mRNA-4157-P201, involved 157 patients with resected high-risk melanoma (stage III/IV) and demonstrated a notable improvement in recurrence-free survival (RFS) and distant metastasis-free survival (DMFS), two critical measures of a cancer treatment's efficacy. The 2.5-year RFS rate was 74.8% for the combination therapy versus 55.6% for KEYTRUDA alone, with benefits observed across various patient subgroups.
Moderna's Senior Vice President, Kyle Holen, expressed optimism regarding the sustained benefits of the combination therapy, emphasizing the potential impact on patient outcomes. Merck echoed this sentiment, with Dr. Marjorie Green highlighting the support these findings provide for the novel approach.
The safety profile of the combination was consistent with previous analyses, with the most common adverse events being fatigue, injection site pain, and chills, mostly of mild to moderate severity. Immune-related adverse events were similar between the combination therapy and KEYTRUDA alone.
Following these encouraging results, Phase 3 studies have been initiated for patients with high-risk melanoma and non-small cell lung cancer, alongside Phase 2 studies in renal cell carcinoma and urothelial carcinoma, and a Phase 2/3 study in cutaneous squamous cell carcinoma.
mRNA-4157 (V940) is an investigational mRNA-based individualized neoantigen therapy (INT) designed to stimulate a patient-specific antitumor immune response. KEYTRUDA, an anti-PD-1 therapy, is already widely used in oncology. The combination aims to enhance the body's immune response to fight cancer cells more effectively.
The information presented is based on a press release statement.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) continues to make strides in the field of oncology with promising clinical trial results, investors and stakeholders are closely monitoring the company's financial health and market performance. Moderna's recent announcement with Merck on the positive Phase 2b clinical trial results has the potential to influence the company's valuation and investor sentiment.
An InvestingPro Tip that stands out in relation to Moderna's current activities is the significant number of analysts who have revised their earnings upwards for the upcoming period. This optimism among analysts could be partially attributed to the potential commercial success of treatments like mRNA-4157 (V940) in combination with KEYTRUDA. Additionally, it's worth noting that Moderna holds more cash than debt on its balance sheet, providing the company with a solid financial foundation to support ongoing research and development efforts.
Looking at the real-time metrics from InvestingPro, Moderna has a market capitalization of $54.63 billion USD, reflecting its significant presence in the biotechnology sector. However, the company's P/E Ratio stands at -9.04, indicating that investors may have concerns about its profitability, especially considering that analysts do not anticipate the company will be profitable this year. Despite these concerns, Moderna's stock has experienced a large price uptick over the last six months, with a 78.57% return, highlighting the market's response to its recent developments and future potential.
For readers interested in deeper financial analysis and additional InvestingPro Tips, including insights into Moderna's sales projections and gross profit margins, visit https://www.investing.com/pro/MRNA. There are 14 more InvestingPro Tips available for Moderna, which can be accessed with a subscription. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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