Eli Lilly knows the participant makeup of its oncology trials doesn't entirely reflect the diversity of the patients affected by diseases such as breast cancer. So, Lilly is once again linking arms with decentralized research organization Care Access.
The Indianapolis Big Pharma worked with Reify Health's Care Access on decentralized trials of its COVID-19 treatment bamlanivimab last year. Now, the two hope to diversify a phase 3 trial of Lilly's approved drug Verzenio in HR-positive and HER2-positive, high-risk, early breast cancer patients.
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The trial, which began in May, will enroll about 2,450 patients who are taking hormone therapy after surgery, and the study is slated to wrap up primary work in May 2025.
Verzenio, or abemaciclib, snagged its first approval in September 2017 for use in patients with HR-positive, HER2-negative metastatic breast cancer who had previously been treated. In 2018, Verzenio use expanded into the first-line setting, or patients who had not received any prior treatment.
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The prescribing information (PDF) for the drug details the three main trials used to garner the approvals and shows the therapy was tested mainly in white patients in those trials. One trial was 58% white and 30% Asian, another was 56% white and the third was 85% white. Other races or ethnicities were not broken out.
"We know that about 16% of the population of women who have breast cancer are brown and Black women, but historically only about 3% of those patients come into clinical trials," said Amy Davis, senior director for Lilly's oncology clinical development, in a Q&A with Fierce Biotech earlier this month. "While our numbers were somewhat higher than that in our trials overall, our goal is to recruit patients who are consistent with the U.S. prevalence of those diseases for those populations."
The goal of the new partnership is to increase the trial participation of African American, Hispanic and Latinx patients, Care Access said Tuesday. Care Access will work with local health systems, physician groups, diversity-focused organizations, advocacy partners and community centers, the company said.
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"While there’s been a 40% decline in breast cancer deaths over the last 30 years, a stark mortality gap remains between Black women and Caucasian women. It’s absolutely critical for our industry to address these hollowing disparities," said Ahmad Namvargolian, Care Access' CEO, in a statement.
The research organization will start by forming partnerships with medical and surgical oncologists from underrepresented groups to serve as principal investigators. Then they will work with community-based partners to reach patients and lastly educate patients with information to help determine whether they should participate based on medical needs.