Eli Lilly announced Verzenio in combination with standard adjuvant endocrine therapy “significantly” decreased the risk of breast cancer recurrence by 25% compared to standard adjuvant ET alone for people with hormone receptor-positive, human epidermal growth factor receptor 2-negative high risk early breast cancer.
This statistically significant benefit was consistent across all pre-specified subgroups and corresponds to a 3.5% difference between arms at two years. These results are from a preplanned interim analysis with 323 IDFS events observed in the intent-to-treat population across both arms, including 136 in the Verzenio arm and 187 in the control arm.
Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed.
At the time of analysis, approximately 70% of patients in each arm were still on the two-year treatment period. The median follow up was approximately 15.5 months in both arms. The median duration on Verzenio was 14 months. The addition of Verzenio to endocrine therapy also resulted in an improvement in distant relapse-free survival, or the time to developing cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 28%, with the largest reductions occurring in rates of metastases to the liver and bone. This treatment benefit was consistent across all prespecified subgroups. Two-year distant relapse-free survival rates were 93.6% in the Verzenio arm and 90.3% in the control arm.
Overall survival results were immature and monarchE will continue through the completion date, estimated for June 2027. At the time of the interim analysis, the IDFS results are considered definitive. All patients on monarchE will be followed until primary analysis and beyond to assess overall survival and other endpoints. Lilly will submit the monarchE data to regulatory authorities before the end of 2020.
“We are excited that Verzenio has demonstrated a clinically meaningful reduction in the risk of recurrence for people with HR+, HER2- high risk early breast cancer, and Lilly would like to thank the patients and investigators around the world who made this trial possible,” said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. “The results on invasive disease-free survival are significant and provide hope for people with high risk early breast cancer living with concerns of recurrence. Lilly will submit these results to regulatory bodies around the world as soon as possible and we look forward to being able to offer Verzenio as a new treatment option for these patients. We are proud of the way monarchE builds on the vast body of clinical evidence established for Verzenio.”
The addition of Verzenio to endocrine therapy also resulted in an improvement in distant relapse-free survival, or the time to developing cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 28 percent (HR: 0.717; 95% CI: 0.559, 0.920), with the largest reductions occurring in rates of metastases to the liver and bone. This treatment benefit was consistent across all prespecified subgroups. Two-year distant relapse-free survival rates were 93.6 percent in the Verzenio arm and 90.3 percent in the control arm.
“The results of monarchE are welcome news for our community,” said Jean Sachs, MSS, MLSP, CEO of Living Beyond Breast Cancer. “Up to 30 percent of people with hormone receptor-positive early breast cancer may have a recurrence, so this finding is an exciting development for those with high risk hormone receptor-positive, HER2- early breast cancer, especially because the trial included women of any menopausal status as well as men.”
On September 18, 2020, Eli Lilly and Company (LLY) and Incyte (INCY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This opinion marks the first step toward European regulatory approval for baricitinib for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.