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Allogene Therapeutics Reports Interim Futility Analysis from Pivotal ALPHA3 Trial Showing 58.3% MRD Clearance with Cemacabtagene Ansegedleucel (Cema-Cel) vs. 16.7% in Observation Arm in First-Line Consolidation LBCL
41.6% Absolute Difference in the Cema-Cel Arm Over the Observation Arm Exceeded Clinically Meaningful Benchmark Based on Literature of 25-30%MRD Reduction
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"41.6% Absolute Difference in the Cema-Cel Arm Over the Observation Arm Exceeded Clinically Meaningful Benchmark Based on Literature of 25-30%MRD Reduction Occurred Rapidly Following Cema-Cel Treatment with a 97.7% Median Decrease in Plasma ctDNA at Day 45 Compared to a 26.6% Median Increase in the Observation ArmCema-Cel Treatment Well-Tolerated with Most Patients Managed Outpatient No Cases of CRS, ICANS, GvHD, or Treatment-Related Serious Adverse EventsNo Hospitalizations for Treatment-Related Adverse Events Community Cancer Centers, Including Sites New to CAR T Therapy, Accounted for Approximately 33% of Screening Activity and Cema-Cel Infusions Enrollment Expected to Complete by Year-End 2027, with an Interim Event-Free Survival (EFS) Analysis Anticipated in Mid-2027 and Primary EFS in Mid-2028Conference Call and Webcast Scheduled for Today at 5:30 AM PT/8:30 AM ET SOUTH SAN FRANCISCO, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today reported data from the planned interim futility analysis of its pivotal, randomized Phase 2 ALPHA3 trial in first-line (1L) consolidation large B-cell lymphoma (LBCL). At the protocol-defined data cutoff, which was triggered when the 24th patient completed Day 45 MRD assessment, 58.3% (7/12) of patients in the cemacabtagene ansegedleucel (cema-cel) arm achieved minimal residual disease (MRD) negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Based on literature,1 2 3 a difference in percentage points of 25-30% in the MRD clearance could translate into meaningful clinical benefit at study completion. In addition, at the first MRD assessment (Day 45), plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm. The Company believes these interim data provide initial support for cema-cel’s potential as a novel strategy for treating high-risk patients at the end of first-line treatment. MRD status post-treatment has emerged as a strong predictor of relapse in LBCL, creating a potential opportunity to intervene earlier in the course of disease, ...