Lilly Gains as Verzenio Meets Early Breast Cancer Study Goal

Eli Lilly & Company’s LLY CDK4 & 6 inhibitor, Verzenio, significantly reduced the risk of cancer returning in a large late-stage study in patients with high risk HR+, HER2- early breast cancer. Verzenio is approved to treat advanced breast cancer and is not approved for an early stage breast cancer indication.

The phase III monarchE study (n= 5,637) met its primary endpoint of invasive disease-free survival (iDFS) by showing that Verzenio in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. The data was presented from a pre-planned interim analysis of the study.

The positive data led the company’s stock up around 16% on Tuesday as the study data could be a game changer in treating breast cancer. Lilly’s shares have risen 24.6% this year so far against a decrease of 5.3% for the industry.

 

Other CDK4 & 6 inhibitors available in the market are Novartis’ NVS Kisqali (ribociclib) and Pfizer’s PFE Ibrance (palbociclib). The CDK4 & 6 inhibitor class of medicines work by inhibiting cyclin-dependent kinases 4 and 6, which interferes with the division of cancer cells and helps stop tumor growth.

While Ibrance was approved by the FDA in 2015, the other two medicines were given the green signal much later in 2017. All three medicines are approved for use in combination with an aromatase inhibitor to treat adults with HR+, HER2- breast cancer that is metastatic, or in other words, has spread to other parts of the body. None of the three medicines are approved yet to treat any early breast cancer indication

Approximately 30% of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning. Verzenio is the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence in early-stage breast cancer patients. The results follow the failure of Pfizer’s Ibrance in an early breast cancer study last month. In May, an independent Data Monitoring Committee (DMC) recommended that a large phase III PALLAS study evaluating Ibrance in early breast cancer is unlikely to show statistically significant improvement in its primary endpoint of iDFS.

Though the positive data for Verzenio were achieved quite early — at interim analysis — Lilly said the study will continue through the estimated completion date of June 2027. Lilly will submit data from the study to regulatory authorities by this year end

Verzenio generated sales of $188.0 million in the first quarter of 2020.

Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anothertop-ranked large pharma stock is AstraZeneca AZN, carrying a Zacks Rank #2 (Buy).

AstraZeneca’s shares are up 7.5% this year so far. Its earnings estimates for 2020 and 2021 have risen by 1% and 1.6%, respectively over the past 60 days.

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