Verzenio (abemaciclib) significantly extends life by a median of 9.4 months for women with HR+, HER2- advanced breast cancer in MONARCH 2 study.- Eli Lilly

Eli Lilly and Company announced Verzenio (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 III MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups. These results were presented 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 their organs, such as liver or lungs (also known as visceral disease; 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 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 Verzenio 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 Verzenio arm remained on treatment versus 4 percent in the placebo arm.

See- "The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor�Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy�MONARCH 2- A Randomized Clinical Trial" George W. Sledge Jr, MD; Masakazu Toi, MD, PhD; Patrick Neven, MD, PhD; et al. JAMA Oncol. Published online September 29, 2019. doi:10.1001/jamaoncol.2019.4782.