Eli Lilly and Company’s phase 3 monarchE trial of their cancer treatment drug Verzenio® (abemaciclib) has demonstrated a significant decrease risk of breast cancer recurrence for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer.
The treatment, combined with standard adjuvant endocrine therapy, presented a 25% reduced risk of recurrence compared to standard adjuvant endocrine therapy alone, according to an Eli Lilly and Company press release. It is the "only CDK4 & 6 inhibitor to demonstrate a statistically significant improvement in invasive disease-free survival (IDFS) in early breast cancer.”
"This is a major milestone for people living with high risk HR+, HER2- early breast cancer – potentially one of the most notable treatment advances in the last two decades for this population of breast cancer patients," Dr. Stephen Johnston said in the release.
Johnston is a professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust in London, and lead investigator for the monarchE trial.
"Abemaciclib added to adjuvant endocrine therapy significantly improved invasive disease-free survival in women and men with HR+, HER2- early breast cancer at high risk of early recurrence, and if approved could represent a new standard of care for this population," he said.
Drawing on 600 sites across 38 countries, the trial included 5,637 randomized patients with HR+, HER2- high risk early breast cancer.
The definition of “high risk” for the trial was based on cancer that spread to the lymph nodes, a large tumor size or high cellular proliferation, according to the release.
"The results on invasive disease-free survival are significant and provide hope for people with high risk early breast cancer living with concerns of recurrence,” Dr. Maura Dickler, vice president of late phase development at Lilly Oncology said. “Lilly will submit these results to regulatory bodies around the world as soon as possible and we look forward to being able to offer Verzenio as a new treatment option for these patients.”
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