Abemaciclib (Verzenio, Eli Lilly) significantly improved overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer previously treated with endocrine therapy, according to a phase 3 study.
Women with advanced stage breast cancer at diagnosis have a 5-year relative survival rate of 27% for metastatic disease, according to Lilly.
The MONARCH 2 study included 669 patients with HR+, HER2- metastatic breast cancer who progressed on endocrine therapy. For the study, abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, was evaluated in combination with fulvestrant compared with fulvestrant alone. Patients in the study had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease.
According to the analysis, abemaciclib plus fulvestrant achieved a statistically significant improvement in OS among both pre/peri- and postmenopausal women. Abemaciclib is the first CDK4 and 6 inhibitor in combination with fulvestrant to achieve these results, according to Lilly. No new safety signals were observed in the analysis.
Previous data from the MONARCH 2 trial demonstrated a statistically significant improvement in progression-free survival, the primary endpoint. Key secondary endpoints include objective response rate, OS, and duration of response.
“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,” Maura Dicker, MD, vice president, late stage development, Lilly Oncology, said in a statement. “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.”
Lilly plans to submit these data to regulatory authorities later this year, according to the press release.
Lilly’s Verzenio (abemaciclib) Significantly Extended Life in Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/lillys-verzenior-abemaciclib-significantly-extended-life-women. Accessed July 30, 2019.