Eli Lilly and Company announced updated results from the pivotal Phase 3 monarchE trial of adjuvant Verzenio in combination with standard endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high risk early breast cancer. These data, which include results for investigational uses in the intent-to-treat and Cohort 1 populations, were presented as an oral presentation at the 2022 San Antonio Breast Cancer Symposium and simultaneously published in The Lancet Oncology. Data include updated results from a prespecified analysis reflecting a median follow-up of 3.5 years, with all patients having now discontinued or completed the two-year Verzenio treatment period. The absolute increase in invasive disease-free survival and distance relapse-free survival continued to deepen in magnitude at four years, to 6.4% and 5.9%, respectively, reflecting improvements from the two- and three-year rates. This IDFS and DRFS benefit was seen across all prespecified subgroups, regardless of Ki-67 score. While overall survival data remain immature at this time, fewer deaths were observed in the Verzenio-plus-ET arm compared to the ET monotherapy arm. There were no new safety findings, and overall results are consistent with the well-established safety profile for Verzenio. "These results from the monarchE trial provide further evidence of the clinically meaningful benefit that adjuvant Verzenio adds to standard endocrine therapy in patients with high risk early breast cancer, a population with an urgent need to intensify therapy. Moreover, this benefit continues to deepen at four years, well beyond the two-year treatment course with adjuvant Verzenio," said Stephen Johnston, M.D., Ph.D., Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and lead investigator for the monarchE trial.
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on LLY:
- Eli Lilly price target raised to $430 from $390 at Cowen
- 3 Analyst-Loved Healthcare Stocks for a Recession
- Lilly Completes Acquisition of Akouos Expanding Efforts to Help People with Genetic Diseases
- Eli Lilly’s (NYSE:LLY) COVID-19 Therapy Loses FDA Authorization
- Eli Lilly says donanemab met all primary, secondary endpoints in Phase 3 study