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# Orca Bio T-Cell Leukemia Trial Meets Endpoint
- URL: https://www.fdaweb.com/orca-bio-t-cell-leukemia-trial-meets-endpoint/
- Published: 2025-03-17T12:00:00.000Z
- Updated: 2026-09-14T14:55:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158835

Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an investigational allogeneic T-cell immunotherapy, in certain leukemia patients met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD). “At one year, the rate for patients who received Orca-T was 78% compared to 38% for patients who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT),” it says. The study evaluated patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukemia. “Overall survival with Orca-T was 94% compared to 83% with alloHSCT at one year, and the cumulative incidence of moderate-to-severe cGvHD was 13% versus 44%, respectively,” it adds.

The company says Orca-T is made using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

The company says that the trial’s secondary endpoint of cumulative incidence of moderate-to-severe cGvHD was 13% in the Orca-T arm and 44% in alloHSCT arm.

Additionally, no new safety issues were identified with Orca-T, and serious (Grade 4 or greater) infections were noted in 6% and 10% of patients in the Orca-T and alloHSCT arms, respectively, according to the company.