ASH 2025 | Toxicity outcomes and healthcare utilization related to outpatient blinatumomab for ALL

Blinatumumab is a bispecific antibody that is used in the treatment of acute lymphoblastic leukemia, or ALL. And the way it works is it binds the T-cells with one hand with CD3 and the tumor cells with the other hand with CD19. And it brings the T-cell and the tumor cell together and kills the tumor cell. And so we’ve known for some time that this antibody has the potential to cause cytokine release syndrome and neurotoxicity similar to CAR T-cells. And so because of that, the FDA recommends that people are admitted for the initiation of the first and second cycle of blinatumumab so that they can have close monitoring in case they develop one of those toxicities. We know anecdotally that a lot of centers are not admitting patients for cycle two. And so we wanted to see how safe that approach is. And so we did a retrospective study where we collected patients from Memorial-Sloan Kettering Cancer Center and also Dana-Farber Cancer Institute in Boston, and I collaborated with Evan Chen and Marlice Luskin over there, and we got a large group of patients together to figure out kind of how the drug was administered in cycle one and cycle 2. And so we found that for Cycle 1, both institutions hospitalized most patients. There was a very small number of Cycle 1 patients that were not hospitalized for Cycle 1, and those were people that had very low levels of ALL in their bone marrow. But for Cycle 2, we actually saw that there were pretty interesting differences where Dana-Farber hospitalized most of their patients for Cycle 2, where Memorial-Sloan Kettering did not. We started most of our cycle two outpatients. And then we looked at toxicity outcomes for those two populations. And we found that there was no worse toxicity for those that received Cycle 2 on the outpatient setting. There was a small proportion of them who did end up needing to get hospitalized later during Cycle 2, but that was a small number, the toxicity was not worse for that group and in fact we found that CRS rates were lower in the patients that were started in the outpatient setting, that might have to do more with diagnosis, so there might be people who are having issues at home and never report to care and so therefore that’s why it may be the rate of CRS is lower. But mportantly, we did not observe any high-grade CRS or ICANS in the ones that were started outpatient. And so we believe that overall starting Cycle 2 outpatient can be a safe approach for many patients, especially those that start with low disease burden and those that do not have any CRS during the first cycle.

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