MONARCH 2 clinical trial results : Eli Lilly and Company (Lilly) said that Verzenio (abemaciclib) in combination with fulvestrant delivered a statistically significant improvement in overall survival in the phase 3 MONARCH 2 clinical trial held for a type of metastatic breast cancer.
The US pharma giant said that the MONARCH 2 clinical trial results were from a pre-planned interim analysis and are definitive.
The late-stage clinical trial assessed the Verzenio, fulvestrant combo for the treatment of women having hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, who had prior treatment with endocrine therapy. The MONARCH 2 clinical trial included pre/peri- as well as postmenopausal women.
As per the analysis, treatment with the Verzenio, fulvestrant combo met its secondary endpoint of overall survival.
Previously, the MONARCH 2 clinical trial showed a statistically significant improvement in progression-free survival, which is the study’s primary endpoint. Based on this key MONARCH 2 clinical trial result, the Verzenio, fulvestrant combo was approved in 50 plus countries. (Read about abemaciclib FDA approval here)
Lilly said that no new safety signals were seen in the latest analysis of MONARCH 2, which is in line with the known safety profile of Verzenio.
Commenting on the MONARCH 2 clinical trial results, Anne White – president of Lilly Oncology, 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.”
Lilly intends to file the data from the MONARCH 2 clinical trial results to regulatory authorities and showcase the detailed findings at a medical meeting to be held later in the year.
Maura Dickler – vice president of Lilly Oncology late stage development, commenting on the MONARCH 2 clinical trial results, 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.”
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