TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) today presented five-year results from the Phase 3 EMPOWER-Lung 1 trial at the IASLC 2024 World Conference on Lung Cancer. The data showed that Libtayo (cemiplimab) monotherapy nearly doubled the median overall survival (OS) and significantly reduced the risk of death and disease progression in patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy.
Patients with ≥50% PD-L1 expression and no EGFR, ALK, or ROS1 aberrations showed a median OS of 26 months with Libtayo, versus 13 months with chemotherapy. The hazard ratio (HR) for death was 0.59, representing a 41% reduction in the risk of death. Progression-free survival (PFS) also favored Libtayo, with a median of 8 months compared to 5 months for chemotherapy, and a 50% reduction in the risk of disease progression (HR 0.50).
The trial permitted patients on Libtayo who experienced disease progression to add chemotherapy. Among these patients, the median OS was 15 months, with a median PFS of 7 months and an objective response rate (ORR) of 28%.
Adverse events (AEs) were consistent with previous findings, with no new safety signals observed at the five-year mark. The most common AEs in Libtayo patients included anemia, decreased appetite, and fatigue.
The results also demonstrated a direct correlation between survival benefits and PD-L1 expression levels. Patients with tumor PD-L1 expression of ≥90% derived the greatest benefit, with a median OS of 39 months.
The potential use of adding chemotherapy to Libtayo following disease progression is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Regeneron's extensive oncology portfolio includes over 30 types of solid tumors and blood cancers, with Libtayo serving as the backbone of many investigational combinations. The company continues to explore the potential of Libtayo in various cancers, both as a monotherapy and in combination with other treatments.
The information in this article is based on a press release statement from Regeneron Pharmaceuticals.
In other recent news, Regeneron Pharmaceuticals continues to make significant strides in the healthcare industry. The company's Factor XI program, recognized for its market potential by RBC Capital, is swiftly moving through the development pipeline. The European Union's approval of Regeneron's Ordspono for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has been highlighted as a key development.
Analyst firms, including TD Cowen and Piper Sandler, have shown optimism about the company's prospects, maintaining positive ratings on the company's stock. Total revenues for Regeneron increased by 12% to $3.55 billion in the second quarter of 2024, primarily driven by strong product sales. Eylea HD sales in the U.S. maintained a 45% market share with $304 million in earnings, while Dupixent global revenues surged by 29% to $3.56 billion.
However, the company anticipates a potential delay in FDA approval for its linvoseltamab treatment and is currently undergoing a DOJ investigation into its marketing practices for Eylea. Despite these challenges, Regeneron has adjusted its full-year 2024 financial guidance, now expecting a gross margin of approximately 89%. These are just a few of the recent developments in the company's ongoing journey.
InvestingPro Insights
In the wake of Regeneron Pharmaceuticals' (NASDAQ: REGN) promising trial results for Libtayo, the company's financial health and market performance remain key considerations for investors. According to InvestingPro data, Regeneron boasts a robust market capitalization of $123.4 billion, reflecting its significant presence in the biotechnology industry. The company's P/E ratio stands at 28.45, indicating investor expectations of future earnings growth, a sentiment echoed by a P/E ratio of 28.55 over the last twelve months as of Q2 2024.
Regeneron's revenue growth further underscores its strong market position, with a 6.46% increase over the last twelve months as of Q2 2024. This is complemented by a quarterly revenue growth of 12.32% in Q2 2024, showcasing the company's ability to expand its financials amidst a competitive landscape.
InvestingPro Tips highlight Regeneron's stability and potential for investors. As a prominent player in the Biotechnology industry, the company operates with a moderate level of debt and its liquid assets exceed short-term obligations, suggesting financial resilience. Additionally, Regeneron's cash flows can sufficiently cover interest payments, reinforcing its solid financial footing.
For those interested in a deeper dive into Regeneron's investment potential, InvestingPro offers additional insights, including 11 more tips that can be accessed at https://www.investing.com/pro/REGN. These tips provide valuable information on the company's performance, including its trading patterns and analyst predictions, which may be particularly relevant given the latest clinical trial outcomes.
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