Clinical TrialApr 13, 2026, 07:32 AM
Allogene's Cema-Cel Shows 41.6% MRD Negativity in ALPHA3 Trial
AI Summary
Allogene Therapeutics reported positive interim data from its pivotal Phase 2 ALPHA3 trial for cema-cel in first-line large B-cell lymphoma. The cema-cel arm demonstrated a 41.6% absolute difference in minimal residual disease (MRD) negativity compared to the observation arm, surpassing the clinically meaningful benchmark. Plasma ctDNA levels also significantly decreased by 97.7% in the cema-cel arm. The treatment was well-tolerated with no severe adverse events, supporting its potential for earlier intervention in high-risk patients.
Key Highlights
- Cema-cel arm showed 41.6% absolute difference in MRD negativity over observation.
- 58.3% of cema-cel patients achieved MRD negativity vs. 16.7% in observation.
- Plasma ctDNA decreased by 97.7% in cema-cel arm at Day 45.
- Cema-cel treatment was well-tolerated with no CRS, ICANS, GvHD, or SAEs.
- ALPHA3 trial enrollment expected to complete by year-end 2027.