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The 2022 Tandem Meetings | Tab-cel for solid organ or allogeneic transplant recipients with EBV-PTLD

Susan Prockop, MD, Boston Children’s Hospital, Dana-Farber Cancer Institute, Boston, MA, gives an update on the Phase III study evaluating tabelecleucel (tab-cel) for solid organ or allogeneic hematopoietic stem cell transplant (HSCT) recipients with Epstein–Barr-positive post-transplant lymphoproliferative disorder (EBV-PTLD) (NCT03394365). 38 patients were analysed with an objective response rate of 50%. This study demonstrated that patients which responded to this therapy had a better overall survival, with a one-year survival of 89.2% compared to 34% in non-responding patients. Another important aspect of this study was the relatively tolerable toxicity profile when compared to other adoptive T-cell therapies. Moving forward, it is important to understand why these T-cell therapies fail to mediate response in some patients. This interview took place at the Transplantation & Cellular Therapy (TCT) Meetings of ASTCT™ and CIBMTR® 2022 in Salt Lake City, Utah.

Transcript (edited for clarity)

What we’re presenting here at this meeting is a planned interim analysis of a Phase III registrational trial for tabelecleucel in the context of refractory EBV-driven PTLD after both hematopoietic and solid-organ transplant. And so eligible for analysis in this interim analysis are 38 patients, and the response rate, the objective response rate was 50%. This is in line with the response rate that we saw previously in single-center trials, as well as multicenter trials...

What we’re presenting here at this meeting is a planned interim analysis of a Phase III registrational trial for tabelecleucel in the context of refractory EBV-driven PTLD after both hematopoietic and solid-organ transplant. And so eligible for analysis in this interim analysis are 38 patients, and the response rate, the objective response rate was 50%. This is in line with the response rate that we saw previously in single-center trials, as well as multicenter trials. And importantly, what we continue to observe is that patients who have response to this therapy also experience improved overall survival. So in the cohort of patients assessed in this interim analysis, the responding patients had one-year overall survival of 89.2% compared with 34% in non-responding patients. So one of the gratifying things is that the toxicity profile that was observed in the context of this interim analysis continues to mirror the toxicity profile seen previously, and it’s been really uniquely different than the toxicity profile associated with other adoptive T-cell therapies. So we don’t see cytokine release syndrome or infusion reactions. We haven’t seen the CRS that is seen for instance, with CAR-mediated toxicities. No, I mean, I think it’s really exciting that there are a number of T-cell therapies in the viral-specific T-cell therapy space now in pivotal trials. And so these are likely going to be available at more than the boutique centers that have run these trials up till now, and will be more widely available for more patients. And I think that’s super exciting. I think the next step on us is to understand how and why these therapies fail to mediate response for those patients in whom they are not curative. And that’s some of the next steps of what we’re doing.

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