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.
On October 2, 2020, FDA approved nivolumab with ipilimumab as first-line treatment for adult patients with unresectable malignant pleural mesothelioma (MPM). The approval was based on results from Study CA209743 (CHECKMATE-743), an open-label trial of patients with MPM randomized to receive nivolumab and ipilimumab for up to 2 years (n = 303) or six cycles of chemotherapy with cisplatin or carboplatin plus pemetrexed (n = 302). Overall survival (OS) was improved for patients who received nivolumab and ipilimumab, with a median OS of 18.1 months [95% confidence interval (CI), 16.8–21.5] compared with 14.1 months (95% CI: 12.5–16.2; HR, 0.74; 95% CI, 0.61–0.89; P = 0.002), for patients who received chemotherapy. The magnitude of benefit was larger for patients with non-epithelioid versus epithelioid histology. Additional clinical pharmacology data support an alternative dosing regimen of nivolumab than evaluated in the trial, which will reduce the number of required treatment visits. This application was reviewed under FDA's Project Orbis, in collaboration with Australia's Therapeutic Goods Administration, Switzerland's Swissmedic, Health Canada, and Brazil's National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária). Nivolumab and ipilimumab is the first drug regimen approved by FDA for MPM since 2004.
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