Racial and ethnic representation in large b‐cell lymphoma trials and real‐world databases

Introduction: In large B-cell lymphoma (LBCL) trials, racial and ethnic representation is difficult to determine due to underreporting in some regions, or because some patients may not provide data. It is difficult to understand the full extent of any underrepresentation of specific races or ethnicities in these trials relative to the prevalence of LBCL in clinical practice. The objective of this study was to characterize racial and ethnic representation in LBCL real-world databases and recently published LBCL studies. Methods: Analyses of the distribution of different racial and ethnic categories were conducted across 6 real-world clinical practice databases from the United States (US): SEER-Medicare, COTA, Medicare, Optum Market Clarity, Optum CDM, and Concert AI RWD. In addition, a targeted review of recently published studies in patients with LBCL was conducted to identify reported race and ethnicity distributions. Distributions were described using counts and percentages for each race (Asian, Black, White, and other/unknown/not reported) and ethnicity (Hispanic, non-Hispanic, and other/unknown/not reported) category. Results: Patients with LBCL from the databases included: COTA (N = 5848), SEER-Medicare (N = 102,548), Medicare (N = 136,466), Optum Market Clarity (N = 19,649), Optum CDM (N = 22,175), and Concert AI (N = 1828). Race and ethnicity distributions are reported in Table 1. Across databases, Asian (2%–6%) and Black (5%–8%) races were substantially lower than White race (69%–88%). Across various lines of therapy, distributions were similar: 3%–5% Asian, 3%–5% Black, and 78%–82% White. Hispanic ethnicity (5%–22%) was substantially lower than non-Hispanic ethnicity (70%–91%). In the targeted review, 14 publications of LBCL therapies were identified; of these, 10 did not report racial/ethnic composition. In 4 publications (Salles et al., 2020; Sehn et al., 2020; Bannerji et al., 2022; and a real-world study by Shenoy et al., 2011), Asian, Black, White, and other/unknown/not reported represented 2%–13%, 0%–7%, 71%–89%, and 1%–11%, respectively. Conclusions: Information on racial and ethnic distributions in LBCL studies is underreported, particularly in global trials. If this information was reported and reflective of LBCL in clinical practice in the US, the numbers of Asian and Black patients would be low at ≤8%, and most patients would be expected to be White and non-Hispanic. Encore Abstract—previously submitted to ASCO 2023 The research was funded by: Genmab A/S and AbbVie Keywords: aggressive B-cell non-Hodgkin lymphoma, cancer health disparities Conflicts of interests pertinent to the abstract J. Munoz Consultant or advisory role Pharmacyclics/AbbVie, Bayer, Gilead/Kite Pharma, Pfizer, Janssen, Juno/Celgene, BMS, Kyowa, Alexion, Fosunkite, Innovent, Seattle Genetics, Debiopharm, Karyopharm, Genmab, ADC Therapeutics, Epizyme, Beigene, Servier, Novartis, MorphoSys/Incyte, Secura Bio, TG Therapeutics, MEI, Lilly/Loxo Honoraria: Targeted Oncology, OncView, Curio, Kyowa, Physicians’ Education Resource, Seattle Genetics Research funding: Bayer, Gilead/Kite Pharma, Celgene, Merck, Portola, Incyte, Genentech, Pharmacyclics, Seattle Genetics, Janssen, Millennium Other remuneration: Speaker’s Bureau: Gilead/Kite Pharma, Kyowa, Bayer, Pharmacyclics/Janssen, Seattle Genetics, Acrotech/Aurobindo, BeiGene, Verastem, AstraZeneca, Celgene/BMS, Genentech/Roche. A. Mutebi Employment or leadership position: Genmab T. Wang Employment or leadership position: Genmab G. Zhang Employment or leadership position: Genmab J. Yu Employment or leadership position: AbbVie J. He Employment or leadership position: Genmab A. Chibber Employment or leadership position: Genmab R. Kamalakar Employment or leadership position: AbbVie M. Jun Employment or leadership position: Genmab K. Adejumo Employment or leadership position: AbbVie S. Yang Employment or leadership position: Genmab A. Kalsekar Employment or leadership position: Genmab