Eli Lilly and Company (Lilly) said that Verzenio (abemaciclib) in combination with fulvestrant significantly extended life in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in a phase 3 trial.
The late-stage study called MONARCH 2 met its secondary endpoint of overall survival for Verzenio in combination with the endocrine therapy fulvestrant. The trial involved 669 patients, who were previously treated with endocrine therapy.
The patients, which included both pre/peri- and postmenopausal women, were randomly grouped in the ratio 2:1 to Verzenio plus fulvestrant or placebo plus fulvestrant.
Lilly oncology president Anne White said: “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.
“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.”
In March 2017, the MONARCH 2 trial met its primary endpoint of progression-free survival (PFS) which helped the drug regimen to be subsequently approved in more than 50 countries. The approval is for certain advanced or metastatic breast cancers.
Verzenio has been designed to specifically inhibit the cyclin-dependent kinases (CDK) 4 & 6 whose increased signalling leads to uncontrolled cell growth in many cancers. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 are thought to have a role in promoting phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.
Lilly will submit the latest data of the MONARCH 2 trial regulatory authorities. The company said that the results pertaining to overall survival were from a pre-planned interim analysis and are definitive.
Lilly oncology late stage development vice president Maura Dickler 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. 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.”