Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell therapy studied in patients with triple-class exposed multiple myeloma (TCE-MM) in the single arm CARTITUDE-1 study. To assess cilta-cel’s effectiveness compared to real-world clinical practice (RWCP), we performed adjusted comparisons using individual patient data from CARTITUDE-1 and LocoMMotion, a prospective, multinational study of patients with TCE-MM. Comparisons were performed using inverse probability weighting (IPW). In CARTITUDE-1, 113 patients were enrolled, and 97 patients were infused with cilta-cel. In LocoMMotion, 248 patients were enrolled, and 170 patients were included in comparisons vs. infused patients. 92 unique regimens were used in LocoMMotion, most frequently carfilzomib-dexamethasone (13.7%), pomalidomide-cyclophosphamide-dexamethasone (13.3%) and pomalidomide-dexamethasone (11.3%). Adjusted comparisons showed that patients treated with cilta-cel were 3.12-fold more likely to respond to treatment vs. RWCP (RR 3.12, 95% CI: 2.24, 4.00), had a reduced risk of progression or death by 85% (PFS HR 0.15, 95% CI: 0.08, 0.29), and a lower risk of death of 80% (OS HR 0.20, 95% CI: 0.09, 0.41). Incremental improvement vs. baseline in HRQOL for cilta-cel vs. RWCP at week 52 as measured by EORTC QLQ-C30 Global Health Status was 13.4 (95% CI: 3.5, 23.6) and increased to 30.8 (95% CI: 21.8, 39.8) when including death as additional information regarding patients’ health status. Patients treated with cilta-cel experienced more adverse events vs. RWCP (any grade:100% vs. 83.5%). Results from this study demonstrate improved efficacy outcomes of cilta-cel vs. RWCP and highlight its potential as a novel and effective treatment option for patients with TCE-MM.
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