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CAR-T Meeting 2021 | ARI-0001 CART19 cells in R/R B-ALL with isolated extramedullary disease

Valentín Ortiz-Maldonado, MD, Hospital Clínic de Barcelona, Barcelona, Spain, discusses the safety and efficacy outcomes of ARI-0001 CART19 cell therapy in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) with isolated extramedullary disease. Results show a good safety profile, the incidence of cytokine-release syndrome (CRS) was 40%, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. Additionally, ARI-0001 therapy was able to achieve long term remissions in this population of patients. This interview took place during the 3rd European CAR T-cell Meeting.

Transcript (edited for clarity)

In this third European CAR T-cell meeting, we will be presenting our safety and efficacy outcomes of ARI-0001 cell therapy in relapsed/refractory B-ALL patients, but we’ll be analyzing a particularly type of patients. We will be talking about patients with isolated extramedullary disease. This is a particularly group of patients that people think that might behave differently than the general ALL population...

In this third European CAR T-cell meeting, we will be presenting our safety and efficacy outcomes of ARI-0001 cell therapy in relapsed/refractory B-ALL patients, but we’ll be analyzing a particularly type of patients. We will be talking about patients with isolated extramedullary disease. This is a particularly group of patients that people think that might behave differently than the general ALL population. So because people might think that as isolated extramedullary disease might be a specific type of disease that might have a different or worse prognosis due to the capacity to abate T-cell immuno vigilance we wanted to assess if this was true or not.

We treated 15 patients with isolated extramedullary disease and one of the first things that caught our attention was that it was a very heavily pretreated group of patients with a median of five prior treatment lines. They will have been exposed to immunotherapy in 46% prior blinatumomab and also 46% prior inotuzumab, and up to 86% prior allogeneic stem cell transplant.

So there were also very heavily pretreated a group of patients. And one of the first things that caught our attention as for safety is that these patients had a particularly good safety profile. There was incidents of all criteria of 14%, 40% sorry, but there was a 0% incidence of severe CRS. Only one patient needed tocilizumab due to grade 2 CRS. On the other hand, there was no case of any grade ICANS. So this particular type of patients might have a different, or maybe a better safety profile than the general ALL population.

The other thing that caught our attention is also there were concerns about the efficacy that might be different than the general ALL population. So with this work the sample size is just too short and maybe the follow-up also is not very long. As far, we seem to see a trend of duration of response and the quality of response that maybe it’s even better than patients with bone marrow relapse.

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Disclosures

Research grants: Fundación Española de Hematología y Hemoterapia
Travel grants: Kite, Celgene, Novartis, Roche, Takeda & Janssen
Consultant or advisory fees: Kite, Celgene-BMS & Novartis.
Honoraria: Kite

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