Lilly Announces Positive Results for Verzenios in MONARCH 3 Study in Patients with HR+, HER2- Breast Cancer
Basingstoke, UK, 30 September 2019. Eli Lilly and Company announced today that Verzenios® (abemaciclib) in combination with fulvestrant significantly extended life by a median of 9.4 months in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy (median of 46.7 months vs median of 37.3 months with placebo plus fulvestrant; HR: 0.757; 95% CI: 0.606, 0.945; P = 0.0137). Results from the Phase 3 MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups. These results were presented today as a late-breaking abstract in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain and simultaneously published in JAMA Oncology.
Additionally, in women previously treated with endocrine therapy whose cancer quickly returned or spread to other parts of the body, called primary endocrine resistance, the results were consistent with the intent-to-treat (ITT) population (HR: 0.686; 95% CI: 0.451, 1.043). Similar results were observed in women whose cancer spread to visceral organs, such as liver or lungs (HR: 0.675; 95% CI: 0.511, 0.891). These are characteristics of aggressive disease that indicate a woman may be more likely to do worse. Both of these analyses were pre-defined and results are consistent with the intent-to-treat (ITT) results from the MONARCH 2 study which had previously demonstrated a statistically significant improvement in the primary endpoint of progression-free survival, with overall survival as a secondary endpoint of the trial.
In addition to extending life, an exploratory analysis of these data has shown abemaciclib in combination with fulvestrant delayed the time to chemotherapy, with a median time to chemotherapy of 50.2 months versus 22.1 months in the placebo arm (HR: 0.625; 95% CI: 0.501, 0.779). In this exploratory analysis, women who died before receiving chemotherapy were included up until the date of death. This finding may be an important treatment consideration in advanced breast cancer as physicians aim to postpone the use of chemotherapy for as long as possible.
The safety profile was consistent with that of the primary analysis of MONARCH 2. No new safety signals were observed with long-term follow-up (median of 47.7 months) and at the time of analysis, 17 percent of patients in the abemaciclib arm remained on treatment versus 4 percent in the placebo arm.
“It has been a major challenge in our field to extend survival, our ultimate goal, with current therapies for HR+, HER2- advanced breast cancer,” said Maura Dickler, M.D., vice president, late stage development, Lilly Oncology. “We are excited that abemaciclib in combination with fulvestrant has demonstrated the ability to improve overall survival. These are clinically meaningful results that confirm abemaciclib can keep advanced breast cancer from progressing and can extend life. Until there is a cure, we will be persistent in exploring how we can help more people live longer with advanced breast cancer.”
These positive results definitively showed that abemaciclib plus fulvestrant reached statistical significance at a pre-planned interim analysis. Lilly will continue to monitor patients enrolled in the trial. Any additional analyses will be considered post-hoc (conducted after the current analysis). Lilly plans to submit these overall survival data to global regulatory authorities. Abemaciclib in combination with fulvestrant is currently authorised for use in more than 50 countries worldwide.
About MONARCH 2 MONARCH 2 is a Phase 3, randomized, double-blind, placebo-controlled trial that enrolled 669 patients with HR+, HER2- advanced or metastatic breast cancer who progressed on endocrine therapy.1 Patients were randomized 2:1 to abemaciclib plus fulvestrant or placebo plus fulvestrant. Abemaciclib was dosed on a continuous dosing schedule until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Key secondary endpoints were objective response rate (ORR), overall survival (OS), and duration of response (DoR). Patients enrolled in the study had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for advanced disease. Patients could not have received chemotherapy or more than one line of endocrine therapy for advanced breast cancer.
The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.2
About Breast Cancer Breast cancer is the most frequently diagnosed cancer in women worldwide with over 2 million new cases diagnosed annually. In 2018, it is estimated that 627,000 women died from breast cancer around the world, representing approximately 15 percent of all cancer deaths among women.3
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating highquality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
Lilly has been operating in the UK since 1934 and employs approximately 800 people throughout the country working in sales and marketing, and research and development. Lilly’s research priorities are aligned with significant UK health needs including diabetes, heart disease, mental health and cancer.
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