It has been announced that abemaciclib demonstrated a statistically significant improvement in overall survival in the Phase III MONARCH 2 clinical trial.
These results were from a pre-planned interim analysis and are definitive.
MONARCH 2 evaluated abemaciclib in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR ), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy.
The study included both pre/peri- and postmenopausal women.
The analysis showed that treatment with abemaciclib in combination with fulvestrant met its secondary endpoint of overall survival.
The MONARCH 2 study previously demonstrated a statistically significant improvement in progression-free survival, the trial's primary endpoint which served as the basis for its approval of this regimen in more than 50 countries around the world.
No new safety signals were observed in this analysis of MONARCH 2, consistent with the established safety profile of abemaciclib.
"I believe we must continue to fight this devastating disease because the women who are living with metastatic breast cancer want to do everything they can to lead more fulfilling lives and be there for those who need them most," said Anne White, president, Lilly Oncology. "While abemaciclib had already shown an impressive benefit for progression-free survival, we are delighted that abemaciclib is the first and only CDK4 & 6 inhibitor in combination with fulvestrant that has significantly extended life for both pre/peri- and postmenopausal women."
"This definitive overall survival analysis from MONARCH 2 showed significant improvement in overall survival for women living with HR , HER2- metastatic breast cancer, a complex disease that remains incurable," said Maura Dickler, M.D., vice president, late stage development, Lilly Oncology. "For many doctors and patients overall survival is the most important endpoint. It's been difficult in the past to achieve meaningful improvements in this endpoint for women with advanced breast cancer, including those whose cancer progressed after prior endocrine therapy."