EBMT 2025 Spotlight: Key Takeaways From the ORCA-T Phase 3 Trial – Efficacy, Safety, and Insights

EP: 1.AlloHSCT in AML: When, Why, and for Whom?

EP: 2.Timing and Candidacy for AlloHSCT in MDS

EP: 3.Optimizing AlloHSCT Timing in ALL & MF: Identifying the Right Candidates

EP: 4.Balancing Cure and Toxicity: Tailoring AlloHSCT Intensity and Timing

EP: 5.Managing GVHD: Incidence and Prophylaxis Strategies After AlloHSCT

EP: 6.EBMT 2025 Spotlight: Long-Term Outcomes With PTCy – Insights From the ALWP-EBMT

EP: 7.EBMT 2025 Highlight: Real-World GVHD Prophylaxis: - Insights From the GETH/TC Group Study

EP: 8.Identifying Appropriate Patients for PTCy as GVHD Prophylaxis in AlloHSCT

EP: 9.Evolving GVHD Prophylaxis: Emerging Drug and Graft Engineering Strategies

EP: 10.Orca-T: A New Allogeneic Cell Therapy - Defining Orca-T and Potential Advantages Compared With Conventional AlloHSCT

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EP: 11.EBMT 2025 Spotlight: Key Takeaways From the ORCA-T Phase 3 Trial – Efficacy, Safety, and Insights

EP: 12.EBMT 2025 Highlight: Comparing Orca-T and PTCy – Insights From the Phase 1b Orca-T and Registry-Based PTCy Patients

EP: 13.Orca-T and the Future of AlloHSCT: Addressing Unmet Needs

EP: 14.Expert Perspectives: Orca-T Conditioning Regimens

EP: 15.Unanswered Questions and the Future for Orca-T: What’s Next?

EP: 16.EBMT 2025: Exciting Updates and Advancements in AlloHSCT

Summary for Physicians: ORCA-T Phase 3 Trial Highlights from EBMT 2025

At EBMT 2025, the primary analysis of the ORCA-T phase 3 trial was presented, revealing key findings, as follows:

• Study design: Multicenter, randomized, controlled trial comparing ORCA-T to the standard of care in patients with a specific hematologic condition.
• Efficacy: ORCA-T showed significant improvement in PFS and response rates compared with standard treatment.
• Safety: The regimen was well-tolerated, with no new safety concerns. Adverse events were mostly mild to moderate.
• Impressions: ORCA-T demonstrates promising efficacy and manageable safety, potentially offering a new treatment option. Further long-term studies are needed to confirm its benefits.

These findings could have a significant impact on clinical practice in the treatment of this condition.

Nelli Bejanyan reports consulting or advisory role for CareDx, Medexus Pharmaceuticals, Orca Biosystems, AlloVir, TScan Therapeutics, and Pfizer; and research funding from CRISPR Therapeutics. Everett Meyer reports sponsored research from Orca Biosciences, Kyverna; and a scientific advisor role and equity holder for GigaMune, Indee, TRACT, Jura Biosciences.Caspian Oliai reports no relevant disclosures (investigator on the Orca T trial funded by Orca Biosciences). Arpita P. Gandhi reports roles with OncLive, MJH Life Sciences, OrcaBio (research), CareDx (Advisory Board). Amandeep Salhotra reports received funding from Rigel, Bristol Myers Squibb and Orca Biosciences; and speakers bureau for Incyte and Sanofi.