Long-Term Benefits of Verzenio for Early-Stage Breast Cancer Confirmed
Taking the targeted therapy Verzenio (chemical name: abemaciclib) with hormonal therapy for two years after surgery for early-stage, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence continues to reduce recurrence risk (the risk of the cancer coming back) after people complete the treatment, according to the latest results from the monarchE study.
The research was presented on Oct. 20, 2023, at the European Society for Medical Oncology (ESMO) Congress 2023.
About Verzenio
Verzenio is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. A kinase is a type of protein in the body that helps control cell division. Verzenio works by stopping cancer cells from dividing and growing. Verzenio is used to treat both early-stage and advanced-stage hormone receptor-positive, HER2-negative breast cancer.
About the monarchE study
The monarchE study included 5,637 people diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence — 5,601 women and 36 men. The people were from 38 countries around the world and joined the study between July 2017 and August 2019.
Most of the women in the study (56.5%) were post-menopausal when they were diagnosed. Nearly 60% of the people in the study were diagnosed with breast cancer that was in four or more lymph nodes.
After breast cancer surgery, the people were randomly assigned to one of two treatment groups:
2,808 people took Verzenio for two years, plus hormonal therapy
2,829 took only hormonal therapy
The people in the study are taking hormonal therapy for five to 10 years. Most of them (68.3%) are taking an aromatase inhibitor; the rest are taking tamoxifen.
Listen to The Breastcancer.org Podcast episode featuring Dr. Stephen Johnston discussing the monarchE study.
Verzenio Reduces Recurrence Risk for Certain Early-Stage Breast Cancers
Sep 25, 2020When early results from monarchE were presented in 2020, only about 12% of the people in the study had completed the full two years of Verzenio, so doctors wondered if the benefits of Verzenio would last after the people finished taking the medicine.
In 2022, researchers presented monarchE results after about four years of follow-up. This means that all the people had completed the two years of Verzenio.
The findings showed Verzenio plus hormonal therapy reduce the risk of recurrence by 33.6% compared to hormonal therapy alone. The results also suggested the people taking Verzenio had better survival, but the researchers didn’t have enough data to do that analysis.
The latest results come after about five years of follow-up. The results showed the benefits of Verzenio continued over time. Compared to people who took only hormonal therapy, people who took Verzenio and hormonal therapy were:
32% less likely to have a recurrence
32.5% less likely to have a distant, or metastatic, recurrence, which means the cancer came back in a place in the body away from the breast
The absolute difference in recurrence rates in people taking Verzenio and hormonal therapy and people taking only hormonal therapy continues to go up the longer the people are followed, meaning the people who took Verzenio are increasingly less likely to have a recurrence. The differences in recurrence rates were:
2.8% at two years of follow-up
4.8% at three years of follow-up
6.0% at four years of follow-up
7.6% at five years of follow-up
Similarly, the absolute difference in distant recurrence rates also continues to go up as time goes on. The differences in distant recurrence rates were:
4.1% at three years of follow-up
5.3% at four years of follow-up
6.7% at five years of follow-up
The data on overall survival – how long the people lived, whether or not the breast cancer recurred – wasn’t ready for this analysis, but the researchers noted that it looks like people who took Verzenio will have better overall survival.
"These five-year monarchE data clearly demonstrate a carryover effect beyond the completion of two years of abemaciclib treatment, with the [invasive-disease-free survival] and [distant-recurrence-free survival] curves continuing to separate, reinforcing confidence in the role of abemaciclib added to endocrine [hormonal] therapy in the adjuvant setting for those with a high risk of recurrence,” said Nadia Harbeck, MD, PhD, director of the Breast Center and chair for conservative oncology in the Department of OB&GYN at LMU University Hospital in Munich, Germany, who presented the results.
Adjuvant treatments are treatments given after surgery.
The researchers are continuing to follow the people in the study and will offer updated information on recurrence rates, distant recurrence rates, and overall survival in the future.
What this means for you
If you’ve been diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence and are deciding on treatments after surgery, these results offer reassuring information about the benefits of Verzenio for this type of breast cancer. You may want to ask your doctor about whether Verzenio plus hormonal therapy is a good option for you.
If you’re currently taking or took Verzenio with hormonal therapy after surgery, the results show that you can expect the benefits of Verzenio to continue.
It’s important to know that diarrhea is a very common side effect of Verzenio. For most people, it starts during the first week or two of treatment. If you’re prescribed Verzenio, you can expect your doctor to tell you to take an anti-diarrheal medicine like Imodium (chemical name: loperamide) preventively.
— Last updated on November 15, 2023 at 7:08 PM