Eli Lilly has announced that its CDK4 & 6 inhibitor Verzenio (abemaciclib) has been found to significantly extended life in women with HR+, HER2- advanced breast cancer.
The drug is the first and only CDK4 & 6 inhibitor in combination with fulvestrant to achieve statistically significant improvement in overall survival, based on the Phase III MONARCH 2 study including both pre/peri- and postmenopausal women whose cancer progressed following endocrine therapy.
The analysis showed that treatment with the combination 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 Verzenio.
"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.
Anne continued, "While Verzenio had already shown an impressive benefit for progression-free survival, we are delighted that Verzenio is the first and only CDK4 & 6 inhibitor in combination with fulvestrant that has significantly extended life for both pre/peri- and postmenopausal women."
Breast cancer is the most common cancer in women worldwide, with more than two million new cases diagnosed in 2018. Advanced breast cancer includes metastatic breast cancer, meaning cancer that has spread from the breast tissue to other parts of the body, and locally or regionally advanced breast cancer, meaning the cancer has grown outside the organ where it started but has not yet spread to other parts of the body.
Lilly plans to submit the data to regulatory authorities and present the detailed data at an upcoming medical meeting later this year.