| Resum: |
The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure. Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons. Hazard ratios (95% confidence intervals) were 0. 38 (0. 23, 0. 61) for IPW, 0. 45 (0. 28, 0. 74) for RA, and 0. 37 (0. 23, 0. 59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure. |
| Nota: |
This study was sponsored by Kite, a Gilead Company. G.H., G.S., M.D., L.O., E.G., P.L.Z., K.L., A.V., M.J., A.O., S.S., C.T., J.L., V.R.Z., J.M.S., A.J.U., L.F., and T.A.E. contributed to the study concept and design, data collection, and interpretation of data. J.M.H.C., J.E.P., and S.K. contributed to the study concept and design, analysis and interpretation of data, manuscript drafting, project administration, statistical analysis, and verification of the underlying data reported in the manuscript. J.J.W., S.W.W., and A.N. contributed to the study concept and design, interpretation of data, project administration, and verification of the underlying data reported in the manuscript. J.R. contributed to the study concept and design, and interpretation of data. All authors reviewed, revised, and approved the final manuscript for submission. |