Verzenio interim results

When given alongside endocrine therapy (ET), Verzenio (abemaciclib) can lower the risk of cancer recurrence and spread compared to standard ET alone in patients with certain forms of early breast cancer who have a high risk of seeing their disease return and spread elsewhere, according to results from a Phase 3 trial.

Data from the study’s interim analysis were presented at the recent European Society for Medical Oncology 2020 Virtual Congress and simultaneously published in the Journal of Clinical Oncology.

Eli Lilly, Verzenio’s manufacturer, is now planning to submit these findings to regulatory authorities worldwide before the end of the year.

“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, and Lilly would like to thank the patients and investigators around the world who made this trial possible,” Maura Dickler, MD, vice president of late phase development at Lilly Oncology, said in a press 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,” she added. “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.”

Verzenio is a cancer medication that works by inhibiting cyclin-dependent kinases (CDK) 4/6, which are enzymes that control cell growth and are usually overactive in breast cancer. It was approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of certain types of advanced or metastatic breast cancers.

The safety and efficacy of Verzenio when given alongside standard ET to treat patients with high-risk, early-stage, hormone receptor positive (HR+), and human epidermal receptor 2 negative (HER2-) breast cancer is currently being investigated in an open-label Phase 3 trial called monarchE (NCT03155997). High risk meant that patients had a large tumor, their cancer cells were highly proliferative, or their cancer had already spread to nearby lymph nodes.

The trial enrolled a total of 5,637 patients from more than 600 sites across 38 countries. During the study, participants were randomly assigned to receive either Verzenio at a dose of 150 mg twice a day in combination with ET, or ET alone, for a period of two years. After completing this first period of treatment, all patients will continue receiving ET for an additional period of five to 10 years.

The main goal of the study was to determine if adding Verzenio to standard ET would prolong the time patients lived until their cancer returned or appeared elsewhere, or died from any cause. Additional goals included determining the effects of the treatment on overall survival and safety assessments.

Data from a pre-planned interim analysis of monarchE now announced by the company showed that when added to standard ET, Verzenio was able to lower the risk of cancer recurrence by 25% compared to ET alone.

From the 323 instances of disease recurrence reported so far in the trial, 136 happened in patients who were receiving Verzenio in combination with ET, and the remaining 187 in those who were being treated with ET alone.

After two years of treatment, the percentage of patients who continued showing no signs of cancer recurrence was higher among those receiving Verzenio with ET, compared to ET alone (92.2% vs. 88.7%).

“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,” Stephen Johnston, MD, PhD, professor of breast cancer medicine and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, and lead investigator of the trial, said in a press release.

“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.

Moreover, the addition of Verzenio to standard ET was also found to lower the risk of cancer spread (formation of metastases) by 28% compared to ET alone. Reductions in the rates of metastases were particularly striking in the liver and bones.

Similar to disease recurrence, the percentage of patients who continued showing no signs of distant cancer spreading was higher among those receiving Verzenio in combination with ET, compared to ET alone (93.6% vs. 90.3%).

The safety profile of Verzenio in this study was consistent with that reported in previous trials. No new safety concerns were identified.

Data about the effects of Verzenio on overall survival were still unavailable at the time this interim analysis was carried out — with a median follow-up of 15.5 months in both treatment groups, and 70% of the patients still completing the study’s two-year treatment period.

Overall survival will continue to be monitored until study completion, which is estimated to be in June 2027.

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