ASH 2024 | Assessing the efficacy and safety of brexu-cel for patients with R/R B-ALL aged 60 and above

Some populations are typically underrepresented in clinical trials, and that typically includes older patients. So in our project, the primary objective was to describe and evaluate the efficacy and safety of brexucabtagene autoleucel in older patients with relapsed/refractory B-cell ALL. And brexu-cel is a CD19 targeting chimeric antigen receptor that is approved by the FDA for the treatment of mantle cell lymphoma, and it was also the first to be approved in the adult patients with ALL population. 

So in our study, we included 296 patients from the real world outcome collaborative of CAR-T and Adult ALL, the ROCCA consortium database. And the ROCCA consortium is a consortium of around 40 institutions, both academic and community, from around the United States. We stratified our patient population into three groups by age. We had 220 patients who were under the age of 60. We had 57 patients who were aged 60 to 69, and we had 19 patients who were 70 plus. And we compared between the patients in terms of efficacy and safety. The things we compared include complete remission rates, progression-free survival, overall survival, and then we looked into acute toxicities after CAR T-cells, including CRS and ICANS. 

And our findings did show that patients with relapse refractory ALL who receive brexu-cel have comparable complete remission rates across the different age groups. We also had similar progression-free survival and overall survival findings. We did notice a trend towards lower 12 months progression-free survival and median progression-free survival in patients who are older than 70, but our numbers were small to see whether this difference is statistically significant. 

Looking at the safety of brexu-cel across the different age groups, the rates of grade 3 to 4 CRS and ICANS were pretty similar between the different age groups, and they were not higher in the older patients age 70 and above. We did also notice that patients age 70 and above had higher rates of all grade ICANS, but that was mainly driven by grade 1 to 2 ICANS, but that also due to the low patient numbers in that group, we couldn’t detect a statistically significant difference and larger numbers and longer follow-ups are needed for that. 

So in general, I do think that our results do show that using brexu-cel in older patients is feasible and the outcomes look promising. But we need to wait for longer follow-up periods and also maybe higher numbers of patients to investigate some of the trends that we observed.

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