Lilly’s Verzenio combo tops Pfizer’s Ibrance and is first CDK4/6 inhibitor to show benefit in HR+,HER2- early breast cancer

pharmafile | June 18, 2020 | News story | Research and Development Eli Lilly, Pfizer, Verzenio, breast cancer, ibrance 


Eli Lilly has shared new phase 3 data on Verzenio (abemaciclib), in combination with endocrine therapy (ET) following surgery, showing the combo met its main goal in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.


The positive data mean that Verzenio is the only CDK4/6 inhibitor to show statistically significant benefit in this indication.

In a study of 5,637 participants, Lilly confirmed that the combo achieved its primary endpoint of reduction in invasive disease-free survival (iDFS) rates, lowering the risk of disease recurrence or death compared to adjuvant ET monotherapy.

According to Lilly, around 30% of HR+, HER2- breast cancer early patients are likely to see their cancer recur, subject to factors including tumour size or whether the cancer has metastasised. Verzenio has just shown its benefit in reducing this risk for this population.

“We’re proud that Verzenio has already treated tens of thousands of people around the world who are living with HR+, HER2- advanced breast cancer,” remarked Anne White, President of Lilly Oncology. “And now 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,” she added.

Lilly’s share value shot up by 18% on announcement of the news. The results place Verzenio in a strong position following the flop of Pfizer’s Ibrance (palbociclib) in late May after the drug, in combination with adjuvant endocrine therapy, failed to show benefit in iDFS, its primary endpoint.

Matt Fellows

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