FNIH Biomarkers Consortium Project Will Evaluate Immunotherapy Treatment Response Using Noninvasive PET Imaging

North Bethesda, MD, March 28, 2024—The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) announces the launch of a project to support noninvasive evaluation of tumor burden and total body immune response in non-small cell lung cancer (NSCLC) immunotherapy patients using medical imaging.

This three-year, $2.1 million FNIH project brings together positron emission tomography (PET) tracer developers and key stakeholders to validate the link between PET imaging and immunotherapy (IO) response to enable use of noninvasive imaging methods in place of tissue biopsies. Project partners include the National Cancer Institute (NCI), the U.S. Food and Drug Administration (FDA), four private sector partners, and one academic partner. These partners will work collaboratively to study how uptake of the identified PET tracers relates to information obtained from surgical extraction of tumor tissue to facilitate treatment monitoring, patient selection, and expedited drug development without invasive biopsies.

“This project is a necessary step toward enabling information to guide improved patient care while minimizing the need for biopsies and improving the patient experience during treatment with immunotherapies,” said Stacey Adam, Associate Vice President, Science Partnerships, Translational Science at FNIH.

IO is a promising cancer treatment strategy that boosts the immune system to selectively kill cancer cells without harming healthy cells. However, at this time, only a minority of patients respond to IO, and there is currently no method available to effectively predict which patients will respond.

Biopsies are the current standard for evaluating a patient’s response to cancer treatment. The information a biopsy provides is localized to the site of extraction, however, and may not represent the overall tumor burden. Biopsies are painful and can be particularly invasive in difficult-to-access areas such as the lungs. There is a pressing need to improve the quality of information available, both to identify patients likely to respond to IO and to monitor patient progress during treatment.

PET imaging is a method for noninvasive, whole-body evaluation of the immune response to IO treatment. [89Zr]Crefmirlimab and [18F]F-AraG are two relatively mature immune-related PET tracers that provide complementary information related to the presence and activity level of immune cells in patients. However, the relationship between tracer uptake and changes in immune activity requires further validation.

The iRelate project will investigate the uptake of these tracers in patients with NSCLC before and during IO treatment. This information will be compared with analyses of tumor tissue from surgical extraction and is expected to lay the foundation for development of PET-based pharmacodynamic biomarkers to identify patients likely to respond to IO and evaluate treatment response.

Public-sector partners

Academic partners

Private-sector partners

Project support

For more information about the project, click here. To read what our partners are saying about the project, click here.

About the Biomarkers Consortium:

The Foundation for the National Institutes of Health’s Biomarkers Consortium leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. The core operations of the Biomarkers Consortium are supported through its contributing membership program, which includes the National Institutes of Health, the U.S. Food and Drug Administration, private industry, and not-for-profit organizations.

About the Foundation for the National Institutes of Health:

The Foundation for the National Institutes of Health builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.