Pharmaceutical company Eli Lilly has announced encouraging results from the Phase III trial of its Verzenio (abemaciclib) treatment for breast cancer.
 

The data shows that two years of adjuvant abemaciclib plus endocrine therapy (ET) reduced the risk of death from breast cancer by 15.8% versus ET alone, resulting in sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS). The trial evaluated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.

The results, published in Annals of Oncology, mean that Verzenio is the first contemporary therapy in over two decades to demonstrate a significant overall survival benefit in adjuvant HR+, HER2−, high-risk early breast cancer.
 

“For patients, survival is what matters most, and abemaciclib plus endocrine therapy represents the first contemporary medicine in over two decades to deliver a clear improvement in overall survival in the adjuvant setting,” said Stephen Johnston, Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Lead Investigator.  

“These results represent an important step forward in the treatment of high-risk HR+, HER2− early breast cancer.”

Abemaciclib was evaluated in the monarchE study, which was a global, randomised, open-label, two cohort, multicentre Phase III clinical trial. The study enrolled 5,637 adults with HR+, HER2-, node-positive EBC at high risk of recurrence across more than 600 sites in 38 countries.

The data presented included results from the primary OS analysis reflecting a median follow-up of 6.3 years. More than 75% of patients were followed for at least four years after completion of the two-year Verzenio treatment period. The study also showed that 32% fewer patients treated with Verzenio plus ET were living with metastatic disease compared to those receiving ET alone (6.4% vs 9.4%, respectively).

Continued long-term follow-up from this trial will help to determine whether this ongoing difference in patients alive with metastatic disease translates into further deepening of survival benefit with time.

 

Bruno Quinney, Content Team, DDW