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INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY), a pharmaceutical giant with a market capitalization of $719 billion and an impressive 80.91% gross profit margin, on Wednesday revealed results from the Phase 3 EMBER-3 study, which evaluated the efficacy of imlunestrant as a treatment for advanced breast cancer. According to InvestingPro data, Lilly maintains a strong financial health score and is recognized as a prominent player in the pharmaceuticals industry. The investigational oral selective estrogen receptor degrader (SERD) demonstrated a significant improvement in progression-free survival (PFS) as both monotherapy and in combination with the CDK4/6 inhibitor Verzenio (abemaciclib).
The study included patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) who had previously seen disease progression on an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor. As monotherapy, imlunestrant reduced the risk of disease progression or death by 38% compared to standard of care endocrine therapy (SOC ET) in patients with ESR1 mutations. When combined with Verzenio, the reduction in risk rose to 43% compared to imlunestrant alone, across all patients irrespective of ESR1 mutation status.
The median PFS for patients with an ESR1 mutation was 5.5 months on imlunestrant monotherapy, versus 3.8 months on SOC ET. The overall response rate (ORR) was also higher with imlunestrant at 14%, in comparison to 8% with SOC ET among these patients. For the combination therapy, the median PFS was 9.4 months for imlunestrant with Verzenio, versus 5.5 months for imlunestrant alone. The ORR for the combination was 27%, against 12% for the monotherapy.
Safety profiles for imlunestrant, both as monotherapy and in combination with Verzenio, were consistent with known profiles of similar treatments, with the majority of adverse events being low-grade. The discontinuation rate due to adverse events was reported as low.
These findings, which were published in The New England Journal of Medicine, will also be presented at the San Antonio Breast Cancer Symposium. The data are being submitted to global health authorities for regulatory review. With revenue growth of 27.41% over the last twelve months, Lilly continues to demonstrate strong market momentum. InvestingPro subscribers have access to over 15 additional key insights about Lilly's financial performance and market position.
Dr. Komal Jhaveri, from Memorial Sloan Kettering Cancer Center and one of the study's principal investigators, highlighted the significance of the results, suggesting that they indicate a potential shift in therapy options for patients with limited current alternatives.
Imlunestrant represents a potential new oral option for advanced breast cancer treatment, providing an alternative to the commonly used fulvestrant, which is administered by injection. The convenience of oral administration and the reduction in injection site pain, as reported by patients, could make imlunestrant a preferable choice for some.
The EMBER-3 trial will continue to assess overall survival as a secondary endpoint, with results yet to mature at the time of the analysis. This study is based on a press release statement from Eli Lilly and Company. Based on InvestingPro's Fair Value analysis, Lilly's stock is currently trading slightly above its calculated Fair Value, reflecting high market expectations for developments like imlunestrant. For detailed analysis and comprehensive insights, investors can access Lilly's Pro Research Report, part of InvestingPro's coverage of over 1,400 US stocks.
In other recent news, digital health company Ro has partnered with pharmaceutical giant Eli Lilly and Company to enhance accessibility to obesity treatments. This collaboration aims to streamline the process for Ro patients to obtain Zepbound single-dose vials through an integration with LillyDirect, a self-pay pharmacy channel. Concurrently, Eli Lilly has announced a new $15 billion share repurchase initiative and a 15% increase in its quarterly dividend, marking the seventh consecutive year of dividend growth. The company's CFO, Lucas Montarce, highlighted an intention to increase the capital returned to shareholders, reflecting the company's robust growth profile.
Eli Lilly also revealed a substantial $3 billion investment to expand its recently acquired manufacturing facility in Wisconsin to increase production capacities for its in-demand weight-loss drug, Zepbound, among other medications. Meanwhile, Bernstein's analysis suggested a potential shift in the Chinese market for GLP-1 drugs used in treating obesity, indicating that domestic pharmaceutical companies could increase their market share. These recent developments highlight Eli Lilly's strategic moves to enhance its product accessibility, shareholder returns, and production capacities while navigating the evolving global market dynamics.
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