Enrollment Low for Black Patients With Hematologic Malignancies On Trials Supporting FDA Approvals of CAR T-Cell Therapy

Contemporary Concepts | <b>Contemporary Concepts in Hematologic Oncology</b>

Investigators observed low enrollment of Black patients on CAR T-cell therapy clinical trials that supported FDA decisions in hematologic malignancies, especially in multiple myeloma.

Enrollment on CAR T-cell clinical trials supporting FDA approvals was notably low among Black patients with hematologic cancers, especially those with multiple myeloma, according to a findings from a study presented at the 2022 Tandem Meeting.

Investigators noted that efficacy data were reported for 74% of the 1051 patients who enrolled on a clinical trial and received treatment with a CAR T-cell therapy. Of the 782 patients who were treated in the trials, only 28 (3.6%) were Black.

As the participation of Black patients in clinical trials that support CAR T-cell therapies has not been well described, investigators launched an analysis to assess and identify any relevant disparities. FDA approvals examined in the analysis took place from August 3, 2017, to March 26, 2021. Almost all patients (96%) who enrolled resided within the United States.

The analysis included 7 clinical trials that led to the approval of several CAR T-cell therapies across different indications:

Investigators calculated the prevalence-corrected estimates for enrollment of Black patients by dividing the percentage of Black patients within a clinical trial population by the percent of Black patients in the disease population.

The most common disease types represented include diffuse large B-cell lymphoma (DLBCL; 58%) and multiple myeloma (16%). Of the 7 studies included in the analysis, 2 did not report racial or ethnic information. Of the overall trial populations, 4% of patients with DLBCL, 6% of patients with multiple myeloma, and 1% of patients in other indications were Black. After adjusting for disease prevalence, investigators reported that participation to prevalence ratio was 0.2 for multiple myeloma, 0.4 for mantle cell lymphoma, 0.6 for DLBCL, and 0.8 in follicular lymphoma.


Al Hadid S, Schinke C, Thanendrarajan S, et al. Enrollment of Black Americans in pivotal clinical trials supporting Food and Drug Administration (FDA) chimeric antigen receptor (CAR)-T cell therapy approval in hematological malignancies. Presented at: 2022 Tandem Meeting; April 23-26, 2022; Salt Lake City, UT. Abstract 248.