Eli Lilly announces results from Phase 3 MONARCH 2 clinical trial
Eli Lilly announced Verzenio in combination with fulvestrant significantly extended life by a median of 9.4 months in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer previously treated with endocrine therapy. Results from the Phase 3 MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups. 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 population. Similar results were observed in women whose cancer spread to their organs, such as liver or lungs. 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. 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 and at the time of analysis, 17% of patients in the Verzenio arm remained on treatment versus 4 percent in the placebo arm. These positive results definitively showed that Verzenio 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. Lilly plans to submit these overall survival data to global regulatory authorities. Verzenio in combination with fulvestrant is currently approved in more than 50 countries worldwide. Additional data for investigational use of Verzenio presented at ESMO include results from the monarcHER trial, the first randomized clinical trial of a CDK4 & 6 inhibitor in combination with endocrine therapy versus standard-of-care chemotherapy for HR+, HER2+ patients, and results from MONARCH plus, the first trial of a CDK4 & 6 inhibitor in a predominatly Chinese population of women with HR+, HER2- advanced breast cancer.