Off-the-shelf CAR-T cema-cel lights up MRD clearance in first-line LBCL, hinting at MRD-guided consolidation

Allogene Therapeutics reported interim futility data from the ALPHA3 trial in first-line LBCL showing cemacabtagene ansegedleucel (cema-cel) achieved MRD negativity in 58.3% of patients vs 16.7% with observation (a 41.6-point edge), and a median 97.7% drop in plasma ctDNA versus a 26.6% rise. The treatment was well tolerated with no CRS/ICANS/GvHD and most patients managed outpatient; community centers contributed about a third of activity. Enrollment aims for ~220 patients with interim EFS data due mid-2027 and primary EFS in mid-2028, and positive results could support an MRD-guided approach and potential BLA submission.