We conclude that CD39 activity and expression are present to varying degrees on all leukocytes types examined. Differences between leukocyte types should be considered when examining CD39 in disease states.
The data suggest this is a well tolerated regimen with modest response rates but with time to progression and survival rates similar to those reported for paclitaxel alone and relatively high rates of stable disease in this sample of patients.
In 2017, the Food and Drug Administration granted accelerated approval of blinatumomab for the treatment of relapsed or refractory precursor B‐cell acute lymphoblastic leukemia. This article focuses on evidence to support conversion from accelerated to regular approval of blinatumomab.
African Americans (AA) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also higher in AA compared toWhite patients. AA more commonly have IgH translocations t(11;14) and t(14;16), compared to Caucasians. We sought to characterize the demographic representation in MM clinical trials and to evaluate outcomes based on race and ethnicity. We conducted a pooled analysis of all trials submitted to the United States (U.S) Food and Drug Administration (FDA) to support approval of a MM therapeutic between 2006 and 2019. Demographic characteristics were analyzed descriptively. An age-adjusted stratified Cox regression model was used to evaluate the relationship between time-to-event outcomes and race and ethnicity. Nineteen global trials comprising 10,157 patients were pooled.White, Asian, and Black patients comprised 84%, 7%, and 4% of the dataset, respectively. Hispanic patients comprised 4%. The age-adjusted overall survival (OS) hazard ratio [HR] for Black compared to White patientss was 0.89 (95% confidence interval [CI], 0.75 to 1.05). The age-adjusted HR for U.S. Black versus U.S. White patients, was 0.82 (95% CI, 0.66 to 1.02). For Rest of World (RoW) Black versus RoW White patients, HR was 1.31( 95% CI, 0.97 to 1.77). Black and Hispanic patients were underrepresented in the trials supporting approval of MM drugs. Black patients were primarily enrolled in the U.S. Outcomes in U.S. patients were more favorable compared to patients in the RoW. Given the higher incidence of MM in AA and different disease characteristics, efforts should be made to improve representation of AA in MM clinical trials.
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