Lilly’s Verzenio scores a win in early-stage breast cancer

In Clinical Studies News by Barbara Jacoby

Positive data was presented at 2020 ESMO virtual congress

In the monarchE trial, patients with hormone receptor positive (HR+), HER2-negative high-risk early breast cancer were given Verzenio (abemaciclib) in combination with endocrine therapy.

In addition to cutting the risk of cancer recurrence by 25%, 7.8% of the Verzenio treatment group had a relapse compared to 11.3% of patient in the control group at the pre-planned interim analysis.

At the time of analysis, approximately 70% of patients in each arm were still within the two-year treatment period, with median follow-up of 15.5 months in both arms. When added to endocrine therapy, Verzenio treatment also resulted in an improvement in distant relapse-free survival – the time it takes for cancer to spread to other areas of the body.

The Verzenio combination reduced the risk of developing metastatic disease by 28 %, with the largest reductions occurring in rates of metastases to the liver and bone. The two-year distant relapse-free survival rate was 93.6% in the Verzenio arm compared to 90.3% in the control arm.

“We are excited that abemaciclib has demonstrated a clinically meaningful reduction in the risk of recurrence for people with HR+, HER2- high risk early breast cancer, and Lilly would like to thank the patients and investigators around the world who made this trial possible,” said 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,” she added.

The positive results for Verzenio in the early breast cancer setting will be a blow for Pfizer’s rival CDK4/6 inhibitor Ibrance (palbociclib), after the therapy failed to improve upon standard therapy to cut recurrence risk in early breast cancer.

Ibrance is a dominant therapy, however, for the treatment of postmenopausal women or men with HR-positive, HER2-negative metastatic breast cancer who haven’t received other hormone therapy.

Lilly plans to submit the data from the monarchE trial to regulatory authorities before the end of 2020, setting the therapy up for potential approval next year.