Eli Lilly and Co. (LLY:NYSE) today announced "Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone."
The firm advised that "the results are from a pre-planned interim analysis of the Phase 3 monarchE study – making Verzenio the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer."
Maura Dickler, M.D., VP of oncology, late-phase development, Lilly Oncology, stated, "When a person is diagnosed with high risk early stage breast cancer, they strive to do everything in their power to prevent a recurrence. And as clinicians, we have the same goal...monarchE was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high risk HR+, HER2- early breast cancer. This would not have been possible without the tremendous commitment from the people who participated in this trial."
The company noted that breast cancer is the most common cancer among women worldwide and explained that even though there has been a lot of progress in treating breast cancer, about 30% of those diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning.
Lilly Oncology's President Anne White commented, "We're proud that Verzenio has already treated tens of thousands of people around the world who are living with HR+, HER2- advanced breast cancer...And now Verzenio in combination with endocrine therapy has demonstrated positive results in people with high risk HR+, HER2- early breast cancer – a major milestone with the potential to change the paradigm of how early breast cancer is treated and a first for the CDK4 & 6 inhibitor class. The fact that these results were achieved early, at the interim analysis, is also exciting because it will help us speed this innovation to people who need it. We look forward to submitting these data to regulatory authorities before the end of 2020."
The company indicated that the monarchE trial has a completion date estimated for June 2027. The firm advised that it is a Phase 3, multicenter, randomized trial that enrolled 5,637 patients with high risk, node positive, HR+, HER2- early breast cancer. The primary objective of the trial was listed as "invasive disease-free survival, which in monarchE is defined as the length of time before any cancer comes back or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes."
The firm stated that "Verzenio® (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation."
Eli Lilly began the day with a market capitalization of around $135.4 billion with approximately 956.4 million shares outstanding. LLY shares opened more than 10.00% higher today at $156.32 (+$14.80, +10.46%) over yesterday's $141.52 closing price and reached a new 52-week high price this morning of $167.43. The stock has traded today between $155.00 and $167.43 per share and is currently trading at $163.56 (+$22.07, +15.60%).
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