Clinical TrialMay 13, 2026, 04:04 PM
Allogene's Cema-Cel Phase 2 ALPHA3 Trial Shows 58.3% MRD Clearance
AI Summary
Allogene Therapeutics reported encouraging interim futility analysis results from its pivotal Phase 2 ALPHA3 trial for cema-cel in 1L LBCL, showing 58.3% MRD clearance in the cema-cel arm with a favorable safety profile, supporting its potential as an outpatient therapy. The company also provided updates on its Phase 1 RESOLUTION trial for ALLO-329 in autoimmune disease, noting early signs of clinical activity and favorable tolerability. Financially, Allogene ended Q1 2026 with $266.9 million in cash and extended its cash runway into Q1 2029 following a $200.4 million public offering in April.
Key Highlights
- Cema-cel arm achieved 58.3% MRD clearance vs. 16.7% in observation arm in ALPHA3 trial.
- Cema-cel arm showed median 97.7% ctDNA decrease from baseline vs. 26.6% increase in observation arm.
- Cema-cel demonstrated favorable safety with no CRS, ICANS, GvHD, or treatment-related SAEs/hospitalizations.
- Nine patients treated in ALLO-329 RESOLUTION trial across Dose Level 1 (20M cells) and Dose Level 2 (40M cells).
- Ended Q1 2026 with $266.9 million in cash, cash equivalents, and investments.
- April public offering added $200.4 million gross proceeds, extending cash runway into Q1 2029.
- Q1 2026 net loss was $42.6 million, or $0.18 per share.
- 2026 operating cash expense guidance increased from $150 million to $165 million.