Orca Bio presented positive three-year follow-up data for its allogeneic T-cell immunotherapy, Orca-T, at the 66th American Society of Hematology (ASH) Annual Meeting. The therapy showed an 86% overall survival rate in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and high-risk myelodysplastic syndrome (MDS), compared to 67% in a historical control group receiving standard post-transplant cyclophosphamide (PTCy). The study also demonstrated potential improvements in non-relapse mortality and relapse-free survival with Orca-T.
Positive long-term data strengthens Orca-T’s potential to become a new standard of care for these life-threatening blood cancers. Currently, treatment options require a difficult balance between managing disease relapse and mitigating severe side effects. Orca-T offers the possibility of improved survival with a reduced risk of complications, addressing a critical unmet need for patients. The positive results also bode well for the ongoing Phase 3 clinical trial comparing Orca-T to conventional allogeneic stem cell transplant, the results of which are expected in the first half of 2025.
The three-year follow-up analysis of the Phase 1b trial compared 77 patients treated with Orca-T plus tacrolimus to a historical cohort of 293 patients receiving alloHSCT with PTCy. All patients in both groups received myeloablative conditioning and had matched donors. The Orca-T group showed superior overall survival at one, two, and three years (96% vs. 82%, 88% vs. 73%, and 86% vs. 67%, respectively). One-year data further indicated a lower non-relapse mortality (1.4% vs. 7.4%) and higher relapse-free survival (83% vs. 71%) with Orca-T. Importantly, the benefit of Orca-T appeared consistent across different age groups. Additionally, the company highlighted the reliable manufacturing process and efficient delivery of Orca-T. Separate data presented at ASH showcased the feasibility of combining Orca-T with CAR-T cell technology (OrCAR-T) in patients with high-risk B-ALL, demonstrating encouraging early safety and efficacy signals.
The promising three-year survival data, coupled with the ongoing Phase 3 trial and the exploration of OrCAR-T, positions Orca Bio as a leader in the development of innovative cell therapies. If the Phase 3 trial confirms these positive findings, Orca-T could significantly improve the treatment landscape for patients with AML, ALL, and MDS, offering a potentially curative option with reduced toxicity. Furthermore, the OrCAR-T platform holds promise for expanding the reach of this technology to other challenging hematological malignancies, paving the way for a new era of personalized and effective cancer treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.