Precision-T phase III subgroup analysis: Orca-T for GvHD prophylaxis

During the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, Everett Meyer presented subgroup results from the phase III Precision-T trial (NCT05316701) evaluating Orca-T vs tacrolimus (Tac) + methotrexate (MTX) as graft-versus-host disease (GvHD) prophylaxis. The analysis examined clinical outcomes in prespecified patient subgroups including age and sex, donor type, disease type, disease risk, and conditioning regimen. The primary endpoint was chronic GvHD (cGvHD)-free survival (cGFS), which was compared between treatment groups for each subgroup.

Key data: In the intention-to-treat (ITT) cohorts, Orca-T had higher cGFS rates at 1 year vs Tac/MTX (78% vs 38%; p < 0.0001). In patients aged >50 years, cGFS rates at 1 year with Orca-T vs Tac/MTX were 74% vs 35% (p = 0.0071). Clinical outcomes favored Orca-T in patients >50 years of age, those with high pretransplant comorbidity scores, and those with high-risk disease scores. 

Key learning: Orca-T demonstrates improved clinical outcomes overall and across patient subgroups with varied demographic and clinical features, suggesting Orca-T benefit extends to patients >50 years of age and those with high-risk disease.