Orca-T Improves GVHD-Free Survival in Advanced Hematologic Malignancies

Amandeep Salhotra, MD, assistant professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, discusses data from the phase 3 Precision-T trial (NCT05316701) of Orca-T in patients with advanced hematologic malignancies.

Orca-T, an investigational allogeneic T-cell immunotherapy, was developed for the potential treatment of hematological malignancies like acute myeloid leukemia, acute lymphocytic leukemia, and myelodysplastic syndrome.

Data from the phase 3 Precision-T trial were presented at the 51st Annual EBMT Meeting. Orca-T was shown to improve moderate-to-severe chronic graft-vs-host disease (cGVHD)–free survival (cGFS) when compared with standard-of-care allogeneic hematopoietic stem cell transplant (allo-HSCT) in patients with advanced hematologic malignancies. For the study’s primary end point of cGFS, Orca-T (n = 93) had a 1-year cGFS rate of 78.0% (95% CI, 65.0%-86.6%) vs 38.4% (95% CI, 26.2%-50.5%) in the 94 patients who underwent allo-HSCT (HR, 0.26; 95% CI, 0.14-0.47; log-rank P < .00001).

“The study met its primary end point, which was the 1-year incidence of chronic GVHD-free survival. The important thing is, if there was any overall survival benefit, we did not see any significant overall survival benefit. But at least at the 1-year mark, 94% of the patients on the Orca-T arm were alive, and there was a trend towards improvement in overall survival,” states Salhotra.

In addition to the primary end point of cGFS, secondary end points of the study include overall survival, relapse-free survival, and other relevant outcomes.

“It will be interesting to see, as longer follow-up kind of happens, if you see a separation of the curves and we see a true survival difference between the 2 arms at the 2- and 3-year mark. That is certainly something that I look forward to…and future studies using the Orca-T product in the reduced intensity setting would be of interest to transplant physicians like myself,” adds Salhotra.

Reference:

Meyer EH, Salhotra A, Gandhi AP, et al. Orca-T demonstrates improved survival free of chronic GvHD compared to conventional allogeneic hematopoietic stem cell transplant: a randomized phase 3 trial in advanced hematologic malignancies. Presented at: 51st Annual EBMT Meeting; March 30-April 2, 2025; Florence, Italy. Abstract OS15-01.