Precision T-Cell Therapy Improves Blood Cancer Outcomes

TOPLINE:

A novel T-cell immunotherapy demonstrates superior outcomes than conventional transplant, with 78% vs 38% survival free of moderate to severe chronic graft vs host disease (CGVHD) at 1 year. Overall survival reached 94% with the new therapy vs 83% with standard treatment, whereas the moderate to severe CGVHD incidence was reduced to 13% from 44%. 

METHODOLOGY:

• Researchers conducted a randomized, phase 3 Precision-T study involving 187 patients (median age, 43.5 [range 19-65] years) with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome, and mixed-phenotype acute leukemia.
• Participants were randomly assigned 1:1 to receive either Orca-T plus single-agent tacrolimus or allogeneic hematopoietic stem cell transplant (allo-HSCT) plus tacrolimus/methotrexate, with both groups receiving myeloablative conditioning.
• Analysis included a median follow-up period of 11.4 (range, 0.2-24.3) months across both treatment arms, with 93 patients in the Orca-T group and 94 in the allo-HSCT group.

TAKEAWAY:

• Primary endpoint analysis revealed significantly higher survival free of CGVHD at 78% (95% CI, 65%-87%) in the Orca-T arm than at 38% (95% CI, 26%-51%) in the allo-HSCT arm (hazard ratio [HR], 0.26; P < .00001).
• Overall survival reached 94% (95% CI, 86%-97%) in the Orca-T group vs 83% (95% CI, 73%-90%) in the allo-HSCT group (HR, 0.49; P = .11823).
• Cumulative incidence of moderate to severe CGVHD was significantly lower at 13% (95% CI, 5%-23%) with Orca-T than at 44% (95% CI, 31%-56%) with allo-HSCT (HR, 0.19; P < .00002).
• Nonrelapse mortality showed marked improvement at 3% with Orca-T vs 13% with allo-HSCT, whereas grade 3 or 4 acute GVHD incidence was 6% vs 17%.

IN PRACTICE:

“Additional treatment options are needed, and the introduction of a cell therapy like Orca-T that leverages a precision-based approach could pave the way for a new standard of care for patients with various hematologic malignancies,” Rawan Faramand, MD, Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, said in a press release.

SOURCE:

The study was led by Ivan Dimov, PhD, Orca Bio in Menlo Park, California. It will be presented at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation in Florence, Italy, in April.

LIMITATIONS:

The median follow-up period of 11.4 months provided relatively short-term data for assessing long-term outcomes and survival benefits. The study population’s age range of 19-65 years may limit generalizability to older patients or pediatric populations.

DISCLOSURES:

Orca Bio provided funding for this study. The therapy has received Regenerative Medicine Advanced Therapy and Orphan Drug Designation from the US Food and Drug Administration.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.