As Eli Lilly looks to broaden use of its breast cancer drug Verzenio, the Big Pharma has teamed up with a big consortium of breast cancer organizations to help push awareness and understanding of the disease.
Many factors influence whether cancer will return or spread, but there are few resources to help people diagnosed with breast cancer understand those risk factors, Lilly says. Now, the Indianapolis-based company is hoping to change that.
Working with Breastcancer.org, For the Breast of Us, Living Beyond Breast Cancer and Susan G. Komen, Lilly is launching a new education campaign that aims to “educate, support, connect, and empower" people diagnosed with early breast cancer that has a high risk of recurrence.
This new initiative is, Lilly says, specifically focused on people diagnosed with the most common subtype of early breast cancer, namely hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)—which also are the types of cancer Verzenio has FDA approvals for.
On a practical level, the consortium is producing new educational materials and other resources specifically developed for people with HR+, HER2- early breast cancer to “better understand the complexity of the disease, including the risk of recurrence,” Lilly explained in a statement.
The campaign features a digital fact sheet, patient conversation guide, and infographic, all of which explain the clinical characteristics associated with an increased risk of breast cancer recurrence.
“When people are diagnosed with early breast cancer, the initial focus is understandably on selecting and undergoing treatment that will prevent or delay cancer recurrence,” said Stacy Moulder, M.D., senior medical director of Lilly Oncology.
“However, the risk of developing recurrence may be difficult to comprehend and patients can benefit from additional resources to help understand or augment the information provided by their doctors.”
Last fall, the FDA approved Lilly’s Verzenio, used in tandem with endocrine therapy, to treat certain patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence after surgery.
The go-ahead made Verzenio the first CDK4/6 inhibitor allowed for adjuvant treatment of breast cancer—given after surgical removal of tumors—though it was third to market overall in the CDK4/6 space, taking the bronze after Pfizer’s market-leading Ibrance and Novartis’ Kisqali.
Verzenio also has a license to treat later-stage patients, namely those who have HR+ HER2- advanced or metastatic breast cancer, and the drug can be used in combination with other therapies in first- and second-line settings.
It brought in $1.34 billion last year for Lilly, up 48% on the year-before period, and made $404 million in the fourth quarter alone.
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The Big Pharma was hoping the latest label in early breast cancer would help lift sales even further, but there was a snag: Only patients who test at least 20% on a biomarker for cellular proliferation, known as Ki-67, are under the FDA’s currently ruling eligible for the new regimen.
In short, the biomarker requirement essentially limits its overall use, and it came as something of a surprise to analysts. Lilly didn’t provide numbers, but analysts at Evaluate Vantage noted at the time that the FDA’s requirement “could reduce Verzenio’s addressable market markedly.”
Lilly is moving toward expanding that label with new data, but Lilly Oncology chief Jake Van Naarden said in a recent interview with Fierce Pharma that the the Ki-67 restriction poses a “legitimate challenge” from a commercial perspective.
A new education campaign that aims to raise awareness of early breast cancer dovetails well with Lilly’s label along with its need to try to boost knowledge and potential uptake of Verzenio in this setting.
And Verzenio has some time on its side: The drug is still the first of its kind to get the green light for adjuvant treatment of breast cancer and comes after Ibrance lost its chance there after failing two trials. Novartis’ Kisqali won’t have a readout from its own adjuvant trial until later this year.
Lilly has not said when it expects the data needed to remove the current biomarker limitation from its label.