Lilly’s therapy hits significant goal in early breast cancer

Pharma News: Eli Lilly’s Verzenio has become the first CDK4/6 inhibitor to show it can significantly cut the risk of cancer recurrence for people with high-risk HR-positive, HER2-negative early breast cancer.

Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone.

These results are from a pre-planned interim analysis of the Phase III monarchE study – making Verzenio the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.

“When a person is diagnosed with high risk early stage breast cancer, they strive to do everything in their power to prevent a recurrence. And as clinicians, we have the same goal,” said Maura Dickler, M.D., vice president of oncology, late-phase development, Lilly Oncology. “monarchE was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high risk HR+, HER2- early breast cancer. This would not have been possible without the tremendous commitment from the people who participated in this trial.”

Lilly’s win puts pressure on its in-class competitors, Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib). 

Despite progress in the treatment of breast cancer, approximately 30% of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning. This risk of recurrence increases based on certain clinical and/or pathological features such as breast cancer that has spread to the lymph nodes, a larger tumour size and a higher tumour grade. New treatment options are needed to advance the field and help prevent early breast cancer from returning, potentially to an incurable metastatic stage.

Anne White, President, Lilly Oncology, said “Verzenio in combination with endocrine therapy has demonstrated positive results in people with high risk HR+, HER2- early breast cancer – a major milestone with the potential to change the paradigm of how early breast cancer is treated and a first for the CDK4 & 6 inhibitor class. The fact that these results were achieved early, at the interim analysis, is also exciting because it will help us speed this innovation to people who need it. We look forward to submitting these data to regulatory authorities before the end of 2020.” 

In Australia, Verzenio is currently reimbursed and indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.