A drug called Verzenio, also known as abemaciclib, in combination with adjuvant endocrine therapy, was said to “significantly” reduce the risk of breast cancer recurrence by 25% for those with a common subtype of breast cancer. The combo treatment also lowered the risk of developing metastatic disease by 28%, with the highest reduction rates to the liver and bone.
According to the World Health Organization (WHO), breast cancer is the most common cancer among women worldwide. The subtype at hand is called hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer. Per separate research, around 70% of breast cancers are HR+, HER2-, the most common subtype, and 30% of people diagnosed with this subtype face the risk of recurring cancer, and possibly incurable metastatic disease.
Lilly’s findings stem from an ongoing, randomized Phase 3 trial called monarchE, involving 5,637 patients with the breast cancer subtype across 38 countries. The trial involves two-year treatment with Verzenio (150 mg twice daily) plus endocrine therapy versus the adjuvant endocrine therapy alone. After the two years, patients will continue on endocrine therapy for five to 10 years, the company said. The monarchE trial will proceed until its expected completion date, around June 2027, officials said.
“The primary objective is invasive disease-free survival (IDFS) ... [which] includes the length of time before any cancer comes back, a new cancer develops or death,” the company said. Verzenio and the endocrine therapy met this goal by showing a “statistically significant improvement” in IDFS in women and men with HR+, HER2- early breast cancer, per the company release.
The findings were presented at the Presidential Symposium at the European Society for Medical Oncology 2020 Virtual Congress and published in the Journal of Clinical Oncology.
“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,” said Dr. Stephen Johnston, professor of breast cancer medicine and consultant medical oncologist at The Royal Marsden NHS Foundation Trust and lead investigator for the monarchE trial.
If the drug is approved, Johnston said, it “could represent a new standard of care for this population.”
Some of the most common adverse effects experienced among participants were diarrhea, neutropenia (low white blood cell count) and fatigue, among others.
“We are excited that Verzenio has demonstrated a clinically meaningful reduction in the risk of recurrence for people with HR+, HER2- high risk early breast cancer,” said Dr. Maura Dickler, vice president, late-phase development, Lilly Oncology. “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.”
"Lilly will submit these results to regulatory bodies around the world as soon as possible,” Dickler added.