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Off-the-shelf CAR-T shows MRD clearance edge in Allogene's ALPHA3 data
healthcarebiotech1 month ago

Off-the-shelf CAR-T shows MRD clearance edge in Allogene's ALPHA3 data

Allogene Therapeutics reports early ALPHA3 data showing its off-the-shelf donor-derived CAR-T therapy cema-cel achieved a 41.6-percentage-point higher minimal residual disease (MRD) clearance at day 45 versus control (7/12 vs 2/12) in lymphoma patients with MRD after initial chemotherapy. Circulating tumor DNA dropped an average 97.7% in cema-cel-treated patients vs a 26.6% rise in control. No cases of cytokine release syndrome or neurotoxicity were observed, and most patients were treated as outpatients. The trial has enrolled just 24 of about 220 planned participants; enrollment is expected to finish by 2027, with event-free survival data due mid-2027 and mid-2028. If results confirm benefit, cema-cel could become the first donor-derived CAR-T therapy to seek FDA approval, potentially reshaping lymphoma treatment access.»

via Fierce Biotech|
#allogene-therapeutics#alpha3#cema-cel
biotech1 month ago

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.

via Allogene|
#alpha3#biotech#car-t