Investigational Cell Therapy May Improve Survival Without Chronic GvHD in Patients With Blood Cancer
March 19, 2025
Orca-T, an investigational allogeneic T-cell immunotherapy, may improve survival free of moderate-to-severe chronic graft-versus-host disease (GvHD) compared with standard allogeneic hematopoietic stem cell transplant (HSCT) in patients with blood cancer, according to results from the phase 3
Precision-T study. Orca Bio, the therapy’s developer,
announced the findings ahead of a presentation at the 51st Annual Meeting of the EBMT, taking place in April.
The study included 187 patients across 19 treatment centers with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome (MDS) or mixed-phenotype acute leukemia. Patients were randomized to receive either Orca-T or conventional HSCT.
At one year, 78% of patients in the Orca-T group were alive without moderate-to-severe GvHD compared with 38% in the HSCT group. Overall survival at one year was 94% in the Orca-T group and 83% in the HSCT group. Patients in the Orca-T group also had a lower cumulative incidence of moderate-to-severe GvHD (13% versus 44%) and fewer cases of grade 3 or 4 acute GvHD (6% versus 17%). No new safety concerns were identified.
Orca-T consists of highly purified regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. The therapy has received
Regenerative Medicine Advanced Therapy (RMAT) and
Orphan Drug Designation from the Food and Drug Administration for the prevention of GvHD or death in patients eligible for HSCT. Orca Bio plans to submit a biologics license application for Orca-T this year.
