Orca-T Shows “Reassuring” Outcomes Across Hematologic Malignancies

In October 2025, the FDA granted priority review to Orca-T, a novel allogenic T-cell immunotherapy, for the treatment of multiple hematological malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndrome.¹ The agency based its decision on data from the phase 3 Precision-T trial (NCT04013685) evaluating Orca-T vs other conventional allogenic hematopoietic stem cell transplantation (alloHSCT) strategies in the aforementioned patient populations.

CancerNetwork^® spoke with Gwen Nichols, MD, executive vice president and chief medical officer at Blood Cancer United, about what the potential FDA approval of Orca-T may represent for patients with different blood cancers. As part of the discussion, she highlighted key efficacy findings from the Precision-T trial, which demonstrated “reassuring” outcomes regarding end points like relapse-free survival and graft-versus-host disease (GVHD).

Updated results presented at the 2025 American Society of Hematology Annual Meeting & Exposition (ASH) showed that Orca-T significantly improved survival free from moderate-to-severe chronic GVHD vs alloHSCT plus tacrolimus (Prograf) and methotrexate, with rates of 78% (95% CI, 65%-87%) vs 38.4% (95% CI, 26%-51%), respectively (HR, 0.26; P <.00001).² Additionally, Orca-T yielded improvements in overall survival (HR, 0.49; P = .11823) and GVHD and relapse-free survival (P <.001).

Transcript:

You want to look at the end point of GVHD, which was less moderate to severe in the Orca-T group. Also, survival seemed to be favored [with Orca-T], and relapse-free survival [also] was favored. The relapse-free survival is an incredibly important point because you don't want to go through the rigors, the cost—and [when] I mean cost, not just dollars cost, but the personal cost of a transplant—only to have the disease come back. If there was evidence that decreasing the chance of graft-versus-host disease increased your chance of relapse, that would be a real negative, and [investigators would] have to do more studies. But that didn't seem to be the case.

That, for me, was reassuring because that was my first question. What we understand is that the immune system helps eliminate leukemia cells, but it can also cause GHVD. It's an intricate balance of many different immune factors... If you use this immune therapy, does it do something to stop the immune effect of the graft against the leukemia, a graft-versus-leukemia effect? It does seem to [stop], at least in this one well-conducted study. It's going to need to continue to be followed, but that was reassuring for the use of this therapy.

References

1. Orca Bio announces FDA acceptance and priority review of the biologics license application (BLA) for Orca-T to treat hematological malignancies. News release. Orca Bio. October 6, 2025. Accessed February 20, 2026. https://tinyurl.com/urwb7244
2. Orca Bio announces Orca-T® phase 3 data published in Blood demonstrate significant improvement in survival free from chronic graft versus host disease in patients with hematological malignancies. News release. Orca Bio. December 15, 2025. Accessed February 20, 2026. https://tinyurl.com/36w99cwm