U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. Analyzing clinical outcomes and genomic data of American Indian patient population treated with immune checkpoint inhibitors for various cancers, including melanoma, non-small cell lung carcinoma and renal cell carcinoma
  1. Oncology Center of Excellence

Analyzing clinical outcomes and genomic data of American Indian patient population treated with immune checkpoint inhibitors for various cancers, including melanoma, non-small cell lung carcinoma and renal cell carcinoma

External Institution: University of Oklahoma Health Sciences Center – Stephenson Cancer Center

External Collaborators: Rafeh Naqash, MD, Minh Phan, MD

FDA Collaborators: Melanie Royce, MD, PhD; Donna Rivera, PharmD, MSC; Catherine Lerro, PhD, MPH; Lola Fashoyin-Aje, MD, MPH; Elizabeth Pulte, MD; Hima Lingam, MD

Project Start Date: October 2022

Regulatory Science Challenge

American Indian patients with cancer have  worse survival compared to White patients, even after controlling for age, sex, alcohol use, tobacco use, type of insurance, and disease stage. Recently, the use of immunotherapy, including immune check point inhibitors (ICI), has demonstrated improved survival in patients with certain cancers.

However, participation of American Indian patients was often not readily apparent in the pivotal clinical trials of ICI demonstrating clinical benefit due to the reporting convention of grouping patients in less common race categories. Thus far, the outcome of American Indian patients’ response to immunotherapy in solid tumors is not known. There is limited genomic and transcriptomic information about the tumors of American Indian patients with cancer who have been treated with ICI.

The objective of this project is to enrich the availability of data for discovering unique biomarkers or mutational patterns among American Indian patients with cancer, which can allow for personalized treatment plans. Personalized therapy can lead to improved outcomes, guide current clinical practice, and provide deep insights into mechanisms of response and resistance to ICI among American Indian patients with cancer. Results from this study will be used to delineate factors associated with resistance or response to ICI therapy, as well as to elucidate novel actionable targets in American Indian patients with cancer and identify potential disparities in outcomes of American Indian patients receiving ICI.

Project Description and Goals

The aims of this study are to:

  1. Develop a multicenter national database of American Indian patients with cancer receiving ICI at NCI-designated cancer centers and comprehensive cancer centers that report on clinical outcomes and toxicity profiles.
  2. Compare and contrast the tumor immune microenvironment and biomarkers of ICI therapy in American Indian and White patients with cancer.

This is a retrospective observational study conducted at tertiary care cancer centers that treat a high volume of American Indian patients.  Adult patients with cancer who self-identified as American Indian and were treated with ICI are included in the analysis. Clinical outcomes including response to treatment, treatment-associated adverse effects, and genomic data will be analyzed.  The data will be used to elucidate potential unique tumor biology and aid in discovering potential novel immuno-oncology based approaches in this patient population. This will potentially help develop interventions to improve clinical outcomes and drug targets for potential biomarkers expressed on the tumors of American Indian patients.

Further Information

 
Back to Top