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Precision-T: A phase III trial of Orca-T vs SoC for cGvHD prophylaxis in advanced hematologic malignancies
Orca-T is an investigational cellular therapy that is enriched with regulatory T cells and conventional T cells, in addition to stem cells.1 Data from the phase III Precision-T trial (NCT05316701) evaluating the efficacy and safety of Orca-T vs SoC for GvHD prophylaxis in patients with advanced hematologic malignancies were presented by Meyer at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).1 Patients with AML, MDS, ALL, or MPAL (N = 187) were randomized to receive Orca-T + Tac (n = 93) or unmanipulated PBSCs + Tac/MTX (n = 94).1 The primary endpoint was the rate of survival free of moderate-to-severe cGvHD. Secondary endpoints included OS, GRFS, and incidence of moderate-to-severe cGvHD.1
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Key learnings |
The rate of moderate-to-severe cGvHD-free survival was higher in the Orca-T group compared with the Tac/MTX group (78% vs 38%; HR, 0.26, 95% CI, 0.14–0.47; p < 0.00001). |
Rates of OS (94% vs 83%; p = 0.11823) and GRFS (63% vs 31%; p = 0.00003) were higher, while the incidence of moderate-to-severe cGvHD was lower (13% vs 44%; p = 0.00002), in the Orca-T vs Tac/MTX groups, respectively. |
1-year NRM rates were nearly four times lower in the Orca-T group vs the Tac/MTX group (3.4% vs 13%). |
The 1-year CI of Grade 3 infections was lower in the Orca-T group compared with the Tac/MTX group (8.4% vs 16%). Death due to GvHD was reported in one patient in the Orca-T group compared with five patients in the Tac/MTX group. |
The rate of SAEs (39% vs 56%), the 1-year incidence of Grade ≥3 aGvHD (6.2% vs 16%), and the proportion of patients re-hospitalized due to AEs (27% vs 46%) were lower in the Orca-T vs Tac/MTX group. |
Orca-T showed improved moderate-to-severe cGvHD-free survival and GRFS rates, and a lower incidence of SAEs, compared with Tac/MTX in patients with hematologic malignancies, demonstrating potential in GvHD prophylaxis. A biologics license application is planned. |
Abbreviations: AE, adverse event; aGvHD, acute graft-versus-host disease; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; CI, confidence interval; cGvHD, chronic graft-versus-host disease; GRFS, graft-versus-host disease relapse-free survival; HR, hazard ratio; MDS, myelodysplastic syndromes; MPAL, mixed phenotype acute leukemia; MTX, methotrexate; NRM, non-relapse mortality; OS, overall survival; PBSC, peripheral blood stem cell; SAE, serious adverse event; SoC, standard of care; Tac, tacrolimus.
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