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

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.