Clinical TrialApr 21, 2026, 08:32 AM
Allogene Expands Pivotal Phase 2 ALPHA3 Study to South Korea & Australia
AI Summary
Allogene Therapeutics announced regulatory clearance to expand its pivotal Phase 2 ALPHA3 study for cemacabtagene ansegedleucel (cema-cel) in first-line large B-cell lymphoma (LBCL) to South Korea and Australia. This expansion adds over 20 new global sites, bringing the total to over 80, and is expected to support continued enrollment and global development. The company recently reported interim futility analysis findings showing cema-cel achieved 58.3% minimal residual disease (MRD) clearance compared to 16.7% in the standard-of-care arm, with a favorable tolerability profile.
Key Highlights
- ALPHA3 study expands to South Korea and Australia, increasing global sites from 60+ to 80+.
- Interim analysis showed 58.3% MRD clearance for cema-cel vs. 16.7% for standard-of-care.
- Cema-cel was well-tolerated with no serious treatment-related adverse events.
- Patient screening and enrollment for the expanded study expected to begin in Q2 2026.
- The ALPHA3 study aims to enroll approximately 220 patients by the end of 2027.