Orca’s cell therapy trounces traditional care in blood cancer phase 3, swimming into space’s ‘holy grail’
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Orca-T met its primary endpoint, showing a statistically significant improvement in survival free of moderate-to-severe chronic graft-versus-host disease (cGvHD) compared to standard allogeneic hematopoietic stem cell transplant (alloHSCT).
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At one year, the rate of survival free from moderate-to-severe cGvHD was 78% for Orca-T vs 38% for alloHSCT.
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Overall survival at one year was 94% for Orca-T vs 83% for alloHSCT.
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The trial enrolled 187 patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL).
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Orca-T showed lower rates of non-relapse mortality (3% vs 13%) and grade 3-4 acute GvHD (6% vs 17%) compared to alloHSCT.
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No new safety issues were identified with Orca-T.
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The results are seen as potentially transformative, offering both good efficacy and low toxicity - described as the "holy grail" in this space.
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Orca Bio plans to submit a biologics license application (BLA) to the FDA this year based on these results.
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The therapy could potentially standardize and improve curative treatment for advanced blood cancers like AML, ALL and MDS.
In summary, Orca-T demonstrated significantly better outcomes than standard stem cell transplants in this pivotal trial, potentially offering a major advance in treatment for these blood cancers. The combination of strong efficacy and improved safety profile is seen as a breakthrough in the field.