Tandem Meetings 2023 | LBA: outcomes of children and young adults with B-ALL following tisa-cel reinfusion
Kevin McNerney, MD, MSc, Johns Hopkins All Children’s Hospital, St. Petersburg, FL, shares the results of a retrospective study evaluating the safety and efficacy of tisagenlecleucel (tisa-cel) reinfusion in children and young adults with B-cell acute lymphoblastic leukemia (B-ALL). Overall, the study showed that second CAR-T infusions were well tolerated, allowed patients to achieve a complete remission (CR) or re-establish B-cell aplasia (BCA), and could be used as a bridge to transplant. However, most remissions were brief and BCA was limited. This interview took place at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR® held in Orlando, FL.
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Transcript (edited for clarity)
So for this study, this was another project that was through the Pediatric Real World CAR Consortium. And so this was presented by Christa Krupski in the late-breaking abstract.
And we conducted a study where we evaluated patients that had received a second infusion with tisagenlecleucel. And we found that patients, and I just want to give you a few numbers here. So we had 43 patients who received a tisagenlecleucel infusion...
So for this study, this was another project that was through the Pediatric Real World CAR Consortium. And so this was presented by Christa Krupski in the late-breaking abstract.
And we conducted a study where we evaluated patients that had received a second infusion with tisagenlecleucel. And we found that patients, and I just want to give you a few numbers here. So we had 43 patients who received a tisagenlecleucel infusion. The median age of patients that were getting infused was 12 and we found a median time to second infusion was 173 days. The indications for reinfusions were non-responsive CAR T-cell patients only in one patient. For B-cell aplasia loss while in an ongoing remission, 26 patients. And then for disease recurrence, which was in 15 patients. And then of 43 patients, we had 35 that received standard lymphodepleting chemotherapy prior to the reinfusion. And there were eight patients that actually received increased lymphodepleting chemotherapy doses.
Overall, the tisagenlecleucel reinfusions were well tolerated and the rates of 3+ CRS were 23%. And the grade three neurotoxicity was only 2%. And then among 16 patients that had been treated with CAR reinfusion due to disease non-response, eight received a morphologic complete remission after the reinfusion. Three of those patients developed a full minute relapse after reinfusion and five achieved an MRD negative status as opposed to just a morphologic complete remission. And then of those four relapse at a median time of 138 days, and then for 26 patients that were reinfused after a BCA loss, five had detectable disease at day 28 and then there were seven that maintained their complete remission status and successfully re-achieved B-cell aplasia at day 28. And they had B-cell aplasia last for about 66 days. And so reinfusion achieved B-cell aplasia in about 33% of patients who had lost B-cell aplasia.
Tisagenlecleucel reinfusion was successfully used to bridge 27 of the 43 patients to a stem cell transplant. And of the 18 evaluable patients, the median time to CAR reinfusion to stem cell transplant was 123 days.
So in summary, we report CAR T-cell refusions are well tolerated and can successfully achieve a complete remission or reestablish B-cell aplasia in some patients. Yet these remissions and ongoing B-cell aplasia is usually brief and so consideration can be given to using it as a bridging therapy to transplant, but is seemingly not as a definitive therapy in most patients.
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