1. Outcomes of Patients Underrepresented in Pivotal Trials of Anti-CD19 CAR-T Cell Therapy
- Author
-
Vera, Daniel Goyco, Lockhart, Jonathan, Carrum, George, Kamble, Rammurti T., Hill, LaQuisa Chimere, Ramos, Dr. Carlos A., Pingali, Sai Ravi, Heslop, Helen E., and Lulla, Premal D.
- Abstract
Three commercial anti-CD19 chimeric antigen receptor modified T-cell therapies (CAR-T) were approved for the treatment of chemo-refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) based on results from pivotal registration trials that had strict inclusion and exclusion criteria. Additionally, despite enrollment across multiple large centers, underrepresented minorities (URMs) accounted for a small portion of the trial participants (e.g., only 11% enrolled to ZUMA1 were non-White). Therefore, there is an unmet need to compare the outcomes of those who were represented in the pivotal trials with those who would have been excluded based on eligibility criteria and those populations that had poor representation. Our cancer center serves a diverse catchment area inclusive of Harris County, where approximately 65% of residents identify as URMs (20% African Americans, 45% Hispanics). Thus, we are ideally located to study outcomes of URMs.
- Published
- 2024
- Full Text
- View/download PDF