Real world and Appalachian comparison of axicabtagene ciloleucel and lisocabtagene maraleucel in relapsed/refractory diffuse large B-cell lymphoma.

Abstract

e19003 Background: Chimeric antigen receptor T-cell therapies targeting CD19, like Axicabatagene ciloleucel (axicel) and Lisocabtagene maraleucel (lisocel), shown efficacy with a tolerable safety treating relapsed/refractory diffuse large B-cell lymphoma (RR DLBCL) in clinical trials. But real-world practice may not be similar. We present a real-world comparison using TriNetX data (TNX) and our experience in a rural Appalachian academic center (WVU). Methods: 2 cohorts were of interest: one with axicel and one with lisocel for RR DLBCL in TNX and WVU. 179 propensity score-matched patients (pts) were analyzed for TNX in each cohort. Total of 39 unmatched pts for WVU. The primary outcome was overall survival (OS). Secondary outcomes were relapse rate, rate of cytopenia 30 days after axicel or lisocel defined by platelet < 50x10 3 /µL (Plt < 50), Hgb < 8 g/dL (Hgb < 8), and ANC < 500/µL, cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). Analysis methods included measures of association, number of instances, and Kaplan-Meier survival estimates. Results: Pts were predominantly Caucasian in both cohorts (TNX: 85.5% in axicel (TNX-A) and 87.7% in lisocel (TNX-L); WVU: 93.8% in axicel (WVU-A) and 100% in lisocel (WVU-L)). No difference in OS in TNX and WVU. Similar relapse rate were noted in TNX. 9.8% difference in relapse rate between WVU-A and WVU-L but not statistically significant. Significant difference in Hgb < 8 and Plt < 50 in WVU, but no difference in TNX. 49.4% more all grade CRS seen with WVU-A (p=0.007). 12.3% more all grade ICANS seen with TNX-A (p=0.009) and 39.8% more in WVU-A (p=0.032). Conclusions: TNX and WVU is comparable to trial data for more all grade ICANS noted in axicel compared to lisocel. More CRS noted with WVU population which is comparable to clinical trial data. Further clinical trials comparing axicel and lisocel is needed to better guide treatment for these pts. Summary of TNX and WVCI. TNX-A TNX-L p-value WVU-A WVU-L p-value Total # of Pts 179 179 - 16 23 0.612 Survival probability, % 35.9 38.2 0.124 50.0 63.4 0.430 Relapse Rate, % 27.9 22.9 0.275 18.8 28.6 0.702 CRS, % 49.7 41.3 0.111 81.3 31.8 0.007* ICANS, % 33.5 21.2 0.009* 62.5 22.7 0.032* Plt < 50, % 31.1 21.9 0.122 68.8 27.3 0.027* Hgb < 8, % 29.9 18.8 0.088 68.8 22.7 0.005* TNX-A: TNX axicel group, TNX-L: TNX lisocel group, WVU-A: WVU axicel group, WVU-L: WVU lisocel group. *Statistically significant result.