New data with Eli Lilly’s CDK4/6 inhibitor Verzenio has sent the drug to the top of the class in patients with hormone receptor-positive, HER2-negative early-stage breast cancer.
Shares in the company leaped 16% in brisk trading after it announced the top-line results of the phase 3 MonarchE trial, saying that Verzenio (abemaciclib) given on top of hormone treatment cut the risk of breast cancer coming back or death compared to hormone treatment alone.
Verzenio is the first drug in the CDK 4/6 inhibitor class to show it improves on standard adjuvant (post-surgery) hormone therapy aimed at reducing the chances of cancer recurring in high-risk patients, stealing a march on rivals Ibrance (palbociclib) from Pfizer – the current class leader – and Novartis’ Kisqali (ribociclib).
Lilly now says it plans to file for approval of Verzenio as adjuvant therapy in this patient population to regulators before the end of the year, opening up what could be a lucrative new market for the drug.
Verzenio has gradually climbed into the mid-table of Lilly’s drugs since its first approval in 2017 as a second-line therapy for HR+/HER2- breast cancer, helped by a green light as a front-line therapy alongside hormonal therapy the following year.
Sales more than doubled to around $580m last year, but were still a long way behind Ibrance which knocked on the door of $5bn in revenues over the same period. At the same time, Kisqali has gathered momentum after a slow start and also doubled its sales to $480m.
With the MonarchE data Lilly now has an opportunity to expand Verzenio into a market where it isn’t playing catch-up with Ibrance, particularly as Pfizer said last month its adjuvant trial in this type of breast cancer – PALLAS – isn’t expected to show a significant improvement on disease-free survival.
Analysts said the size of the market in adjuvant, early-stage breast cancer could be upwards of $2bn worldwide. Around two-thirds of all breast cancer cases fall into the HR+/HER2- category, and roughly a third of people diagnosed with HR-+/HER2- early breast cancer are at high risk of the disease returning.
Meanwhile, Lilly also showed that Verzenio could have a benefit in the HER2+ population in the MonarcHER trial reported last year.
That study found that the drug – given with Roche’s anti-HER2 antibody Herceptin (trastuzumab) and fulvestrant – cut the risk of disease progression or death by a third compared to Herceptin plus chemo.
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June 17, 2020 at 06:27PM
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Lilly surges on Verzenio survival data in early breast cancer - PMLiVE
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