Eli Lilly Korea said that Verzenio (Ingredient: Abemaciclib) demonstrated a statistically significant improvement in overall survival in phase 3 MONARCH 2 clinical trial.
|Lilly’s metastatic breast cancer treatment Verzenio|
The MONARCH 2 trial evaluated Verzenio 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 and postmenopausal women.
The result data showed that Verzenio, in combination with fulvestrant, met its secondary endpoint of overall survival (OS). The MONARCH 2 study had 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.
The data also showed no new safety signals and were 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," Lilly Oncology President Anne White said.
"While Verzenio had already shown an impressive benefit for progression-free survival, the company is delighted that Verzenio is the first and only cyclin-dependent kinase (CDK) 4 & 6 inhibitor in combination with fulvestrant that has significantly extended life for both pre/peri- and postmenopausal women, she added.
Lilly plans to submit these data to regulatory authorities and present the detailed data at an upcoming medical meeting later this year.
Maura Dickler, vice president for Lilly Oncology's late-stage development division, also said, "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. For many doctors and patients, overall survival is the most important endpoint."