Orca-T Improves Chronic GVHD-Free Survival in Hematologic Cancers

The phase 3 Precision-T trial (NCT05316701) supported the FDA approval of allogeneic regulatory T cell–containing immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi; Orca-T) in combination with matched hematopoietic stem cell transplantation (HSCT) and a myeloablative conditioning regimen for patients with hematologic malignancies on June 30, 2026.^1,2 Among 187 patients with acute leukemias or myelodysplastic syndrome, 1-year chronic graft-versus-host disease (GVHD)–free survival was 78% with Orca-T vs 38.4% with a conventional allograft.

Wendy Stock, MD, spoke with CancerNetwork^® about the key takeaways from these data and what remains to be studied. She is the Anjuli Seth Nayak Professor of Medicine, cochair of the Leukemia Committee for the National Cancer Institute–supported Alliance for Clinical Trials in Oncology, and coleader of the Clinical and Experimental Therapeutics Research Program at the University of Chicago Medicine Comprehensive Cancer Center.

Transcript:

CancerNetwork: What do you hope others take away from this conversation, as well as the approval overall?

Stock: I think the most important point is that the primary end point was achieved, which was very statistically significant GVHD-free survival in patients who received Orca-T—the regulatory T cells infused. There were hints of other potentially good outcomes as well from this trial: fewer infections, quicker time to engraftment, and potentially even less acute GVHD. But that all needs to be followed up on in subsequent studies with longer follow-up because perhaps relapse-free survival and overall survival will also be better. That has not yet been shown, but perhaps it will be.

I think the big takeaway is that over the last 10 years, we have incredibly exciting, still-to-be-tweaked methods for improving outcomes for patients undergoing transplant, which is such an important procedure for curing or [achieving] long-term survival for patients with acute leukemias and high-risk myelodysplastic syndromes. This is a big advance, and it needs to be studied further, including comparisons with other major improvements in the world of transplant, such as post-transplant cyclophosphamide.

Of course, I do not know what the cost of this product is, but it is going to be expensive; it will increase costs, and that is another question that can be answered in a prospective trial comparing [Orca-T vs post-transplant cyclophosphamide] in a similar population.

References

1. FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies. News release. FDA. June 30, 2026. Accessed June 30, 2026. https://tinyurl.com/38s3wznr
2. Meyer EH, Salhotra A, Gandhi AP, et al. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026;147(11):1168-1177. doi:10.1182/blood.2025031313