Orca Bio’s Orca-T Shows Groundbreaking Results in Late-Stage Blood Cancer Trial
In a major step forward for cell therapy innovation, Orca Bio has announced compelling results from its pivotal Phase 3 Precision-T trial evaluating Orca-T, an investigational allogeneic T-cell immunotherapy designed to improve outcomes in patients with serious haematological malignancies.
The late-stage study focused on patients diagnosed with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), high-risk myelodysplastic syndrome (MDS), and mixed-phenotype acute leukaemia (MPAL).
Participants were randomised to receive either the novel Orca-T combined with single-agent tacrolimus (TAC) or a standard allogeneic haematopoietic stem cell transplant (alloHSCT) alongside TAC and methotrexate.
Importantly, the trial met its primary endpoint, showing a statistically significant improvement in survival without moderate-to-severe chronic graft-versus-host disease (cGvHD) for those treated with Orca-T.
At the one-year mark, 78% of Orca-T patients remained free of moderate-to-severe cGvHD, compared to just 38% of those who underwent standard alloHSCT.
In addition to better GvHD outcomes, Orca-T demonstrated a one-year overall survival rate of 94%, outpacing the 83% survival seen in the standard transplant group. The cumulative incidence of moderate-to-severe cGvHD at one year also favoured Orca-T, coming in at 13% versus 44% for conventional therapy.
With these promising results in hand, Orca Bio confirmed it is preparing to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) later this year.
The company’s Co-Founder and Chief Executive Officer expressed optimism about the therapy’s future, highlighting that Orca-T not only meets a critical medical need but also validates the potential of the company’s high-precision cell therapy platform.
Reinforcing Orca Bio’s broader vision, the CEO also expressed that these results support the validity of their platform as they continue to advance a pipeline of allogeneic cell therapies targeting haematologic malignancies, autoimmune diseases, and beyond.
Conclusion
Orca Bio’s Phase 3 Precision-T trial marks a significant milestone in the treatment of life-threatening blood cancers. With Orca-T delivering improved survival and dramatically reduced rates of chronic GvHD, the therapy stands as a powerful testament to the evolving capabilities of precision-engineered immunotherapy.
As the company gears up for FDA submission, the future of allogeneic cell therapies – both for haematologic malignancies and potentially other disease areas – has never looked more hopeful.
News Credits: Orca Bio’s T-cell therapy shows promise in haematological malignancies
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