Allogene’s off-the-shelf CAR-T shows early MRD clearance and outpatient potential in first-line LBCL (ALPHA3 interim)

Allogene Therapeutics reported interim futility data from the ALPHA3 trial in first-line consolidation LBCL, showing 58.3% MRD negativity with cemacabtagene ansegedleucel (Cema-Cel) vs 16.7% in the observation arm, a 41.6-point absolute difference that aligns with literature suggesting meaningful potential benefit. Day-45 plasma ctDNA decreased 97.7% in the Cema-Cel arm versus a 26.6% median increase in the observation arm. The regimen was generally well-tolerated with no CRS, ICANS, or GvHD and most patients managed outpatient; enrollment is ongoing with interim EFS expected in mid-2027 and primary EFS in mid-2028, and a potential BLA submission if results remain favorable. Community centers contributed about one-third of screening and infusions, underscoring broader access potential for an off-the-shelf CAR-T therapy.