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Lilly boosted by survival data for key growth drug Verzenio

Chases Pfizer's Ibrance

Lilly

Eli Lilly has the data readout it wanted to keep new breast cancer drug Verzenio firmly on a growth track as it chases after class leader Ibrance from Pfizer.

New results from the MONARCH 2 trial have shown that the CDK4/6 inhibitor achieved a statistically significant improvement in overall survival in pre-, peri- and post-menopausal women with advanced, metastatic breast cancer.

In the study, Verzenio (abemaciclib) – given alongside hormonal drug fulvestrant – was better than fulvestrant plus placebo at extending the lives of women with hormone receptor-positive, HER2-negative advanced breast cancer who had previously been treated with endocrine therapy.

Verzenio was approved for this indication based on progression-free survival (PFS) data from MONARCH 2 in 2017, but the new results allowed Lilly to claim it was the first CDK4/6 inhibitor to show a survival benefit over fulvestrant alone in these patients.

However, shortly after the top-line data were announced, Novartis reported results with a trial of its rival CDK4/6 inhibitor Kisqali (ribociclib) which stole some of Lilly’s thunder.

Results from the MONALEESA-3 in post-menopausal women with HR+/HER2- breast cancer showed that Kisqali and fulvestrant also achieved a significant improvement in OS in both the first- and second-line setting.

That builds on earlier results with Novartis’ drug in the MONALEESA-7 trial, which involved only pre- and peri-menopausal women with HR+/HER2- breast cancer but also found an OS benefit when it was given first- and second-line alongside aromatase inhibitor drugs.

Both companies say they plan to submit these data later in the year to regulatory authorities and present the findings at upcoming medical meetings.

Verzenio brought in $243m in sales for Lilly in the first half of this year, and is growing at a healthy pace but still has a long way to go before it can challenge first-to-market Ibrance (palbociclib), which grew 22% to $2.4bn in the same period.

The new data could help the drug gain ground in Ibrance, but analysts suggest the main battle is for second place with Kisqali, which made $202m in the first six months of this year.

Lilly is also testing Verzenio alongside aromatase inhibitors in the first-line setting in the MONARCH-3 trial, but doesn’t yet have survival data so for now Novartis has a clinical advantage.

Article by
Phil Taylor

1st August 2019

From: Research

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