Aster Insights Announces Research Partnership with FDA to Study the Effects of Patient Demographics on Diagnostic Indicators Used for Checkpoint Inhibitor Therapy

Collaboration will focus on optimizing detection of biomarkers in diverse populations of patients with cancer and the development of novel research algorithms

Tampa, FL / April 8, 2024 / Aster Insights, the leading provider of scientific and clinical intelligence for oncology discovery, today announced a research collaboration with the Food and Drug Administration (FDA). This multi-year research endeavor will begin with research to investigate the differences in scoring algorithms used in diagnostic tests to determine whether a patient is a suitable candidate for immune checkpoint inhibitor (ICI) therapy.

The initial project will examine tumor mutational burden (TMB) in over 20,000 patients with solid tumor malignancies. TMB is a measure of the number of mutations in the DNA of a patient’s cancer cells. A greater number of mutations leads to a higher TMB and increases the likelihood that a patient with cancer may respond to ICI treatment. Current methods and algorithms guiding clinical decision-making as to whether a patient with high TMB cancer should be on an ICI is based on data that may skew toward certain patients of Northern European descent, potentially biasing results for more ethnically diverse patient populations.

Together with scientists at the FDA Oncology Center of Excellence, Aster Insights will utilize its wealth of patient data to explore ethnic differences in TMB scoring based on current testing methods. The study aims to determine if a “one size fits all” standard for assessing TMB is the best approach for predicting response to ICIs across tumor types and populations, or whether diverse populations warrant different standards. Aster Insights researchers will develop a more exact TMB to match the racial and ethnic background of each patient and enable clinicians to determine the best course of treatment on an individual basis.

“Our research with FDA will help improve outcomes in a way that embodies personalized medicine for every patient with cancer,” said Dr. Todd Johnson, Chief Growth Officer of Aster Insights. “Improving diagnostic algorithms to appropriately account for the race and ethnicity of each patient is a critical innovation needed in oncology today, to ensure all patients are directed to the best course of treatment.”

Aster Insights is conducting a planned five-year study utilizing data and expertise from the Oncology Research Information Exchange Network® (ORIEN), which consists of leading national cancer centers across the U.S. ORIEN® members partner with Aster Insights in leading Total Cancer Care® (TCC), the world’s largest and longest running observational research study in oncology. Patients with cancer who are enrolled in TCC® provide a lifetime connection to their health journey, including multimodal data that is used to discover and develop new drugs, biologics, and diagnostics.

“Analyzing deep molecular data and a diverse patient cohort across many cancer types is the crucial combination to unlock new insights into how we can better test and treat cancer,” said Dr. Michelle Churchman, Scientific Director at Aster Insights. “By partnering with experts from FDA, we have a unique opportunity to enhance our collaboration with ORIEN® to improve outcomes for millions of patients with cancer.”

About Aster Insights

Aster Insights is the leading provider of scientific and clinical intelligence for oncology discovery. We partner with drug, biologics, diagnostics, and medical device developers to accelerate oncology product discovery and development. Aster Insights leads the Oncology Research Information Exchange Network® (ORIEN), a consortium of the nation's leading cancer centers that conduct Total Cancer Care®, the world's largest and longest running observational research study in oncology. Together, we are changing the way cancer is studied, treated, and prevented. Follow us on LinkedIn and Twitter.