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• W2913408031 abstract "IntroductionIn haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT), different strategies are used to eliminate alloreactive T cells, one of which can be performed in vivo early after T-cell-replete haplo-HSCT using post-transplant cyclophosphamide (PTCy). Currently under development is T-cell-depleted haplo-HSCT supplemented with T-lymphocytes that are depleted ex vivo of their alloreactive component (ATIR101; Kiadis Pharma). Both strategies are promising, but comparisons of clinical outcomes obtained in similar patient populations have not been performed.MethodsData from published retrospective studies were analyzed to assess clinical outcomes of haplo-HSCT plus PTCy, and 1-year outcomes were compared with a pooled analysis of 2 phase II clinical trials of a single dose of ATIR101 in 37 AML/MDS/ALL patients. Studies in which PTCy was used in patient populations with >50% AML/MDS/ALL were identified (Table). The 1-year rates of relapse, relapse-related mortality (RRM), non-relapse mortality (NRM), graft-versus-host disease (GVHD), and overall survival (OS) for the ATIR101 clinical trials were compared with the weighted average of these outcomes for the identified studies. Differences in disease risk index (DRI) between PTCy and ATIR101 study populations were adjusted according to the relationship between DRI and OS. Finally, PTCy studies reporting GVHD-free and relapse-free survival (GRFS) were identified. One-year GRFS rates from 2 haplo-HSCT plus PTCy studies reporting DRI status were also normalized according to the DRI profile in the ATIR101 clinical trials to allow comparison.ResultsThe weighted average of PTCy outcomes in populations with >50% AML/MDS/ALL vs ATIR101 patient outcomes were 29% vs 8% for relapse; 18% vs 8% for RRM; 22% vs 33% for NRM; 5% vs 5% for acute GVHD grade III/IV; 24% vs 3% for chronic GVHD; and 60% vs 58% for OS. The OS in DRI-adjusted studies for PTCy was similar to that in ATIR101 clinical trials (63% vs 58%, respectively, Table). One-year GRFS rates for PTCy were 33% (95% CI: 25–41) (Solh 2016), 45% (95% CI: 40–50) (McCurdy 2017), and 33% (average) (Santoro 2017). The DRI profile was more favorable than in the ATIR101 studies and the normalized 1-year GRFS rates were reduced to 30% (Solh 2016) and 40% (McCurdy 2017). In patients intended to receive a single dose of ATIR101 after haplo-HSCT, 1-year GRFS estimate was 53% (95% CI 39–72).ConclusionAlthough not a head-to-head comparison, these cross-study analyses provide first insights into a potential advantage of ex vivo (ATIR101) over in vivo (PTCy) depletion of alloreactive T cells, including but not limited to rates of relapse, chronic GVHD, and GRFS. A large, phase III, randomized control trial is underway to assess the relative safety and efficacy of ATIR101 after T-cell-depleted haplo-HSCT versus PTCy after T-cell-replete haplo-HSCT (CR-AIR-009 HATCY; NCT02999854). In haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT), different strategies are used to eliminate alloreactive T cells, one of which can be performed in vivo early after T-cell-replete haplo-HSCT using post-transplant cyclophosphamide (PTCy). Currently under development is T-cell-depleted haplo-HSCT supplemented with T-lymphocytes that are depleted ex vivo of their alloreactive component (ATIR101; Kiadis Pharma). Both strategies are promising, but comparisons of clinical outcomes obtained in similar patient populations have not been performed. Data from published retrospective studies were analyzed to assess clinical outcomes of haplo-HSCT plus PTCy, and 1-year outcomes were compared with a pooled analysis of 2 phase II clinical trials of a single dose of ATIR101 in 37 AML/MDS/ALL patients. Studies in which PTCy was used in patient populations with >50% AML/MDS/ALL were identified (Table). The 1-year rates of relapse, relapse-related mortality (RRM), non-relapse mortality (NRM), graft-versus-host disease (GVHD), and overall survival (OS) for the ATIR101 clinical trials were compared with the weighted average of these outcomes for the identified studies. Differences in disease risk index (DRI) between PTCy and ATIR101 study populations were adjusted according to the relationship between DRI and OS. Finally, PTCy studies reporting GVHD-free and relapse-free survival (GRFS) were identified. One-year GRFS rates from 2 haplo-HSCT plus PTCy studies reporting DRI status were also normalized according to the DRI profile in the ATIR101 clinical trials to allow comparison. The weighted average of PTCy outcomes in populations with >50% AML/MDS/ALL vs ATIR101 patient outcomes were 29% vs 8% for relapse; 18% vs 8% for RRM; 22% vs 33% for NRM; 5% vs 5% for acute GVHD grade III/IV; 24% vs 3% for chronic GVHD; and 60% vs 58% for OS. The OS in DRI-adjusted studies for PTCy was similar to that in ATIR101 clinical trials (63% vs 58%, respectively, Table). One-year GRFS rates for PTCy were 33% (95% CI: 25–41) (Solh 2016), 45% (95% CI: 40–50) (McCurdy 2017), and 33% (average) (Santoro 2017). The DRI profile was more favorable than in the ATIR101 studies and the normalized 1-year GRFS rates were reduced to 30% (Solh 2016) and 40% (McCurdy 2017). In patients intended to receive a single dose of ATIR101 after haplo-HSCT, 1-year GRFS estimate was 53% (95% CI 39–72). Although not a head-to-head comparison, these cross-study analyses provide first insights into a potential advantage of ex vivo (ATIR101) over in vivo (PTCy) depletion of alloreactive T cells, including but not limited to rates of relapse, chronic GVHD, and GRFS. A large, phase III, randomized control trial is underway to assess the relative safety and efficacy of ATIR101 after T-cell-depleted haplo-HSCT versus PTCy after T-cell-replete haplo-HSCT (CR-AIR-009 HATCY; NCT02999854)." @default.
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• W2913408031 date "2019-03-01" @default.
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• W2913408031 title "Differential Outcomes for Ex Vivo Versus In Vivo Alloreactive T-Cell Depletion Strategies in Haploidentical HSCT" @default.
• W2913408031 doi "https://doi.org/10.1016/j.bbmt.2018.12.283" @default.
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