Shots:
- The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies
- Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, & mixed-phenotype acute leukemia
- Trial showed that Tregzi was superior to alloHSCT, achieving 78% vs 38% chronic cGFS (1EP), reducing the rate of chronic GVHD (13% vs 44%) & non-relapse mortality (3% vs 13%), while improving OS (94% vs 83%) & GVHD-free and relapse-free survival (63% vs 31%)
Ref: Businesswire | Image: Orca Bio | Press Release
Related News: Orca Bio Presents New Clinical Data On Orca-Q and Orca-T/CAR-T Combination Therapy at ASH 2025
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