Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company, reported data from the planned interim futility analysis of its pivotal, randomised Phase 2 ALPHA3 trial of Cemacabtagene ansegedleucel (Cema-Cel) in first-line consolidation of large B-cell lymphoma (LBCL).
Following the news, ALLO is up 44.12%, up $3.95.
Phase 2 ALPHA3 Interim Findings
This interim futility analysis was based on the first 24 patients randomised as 12 in the cema-cel arm and 12 in the observation arm and followed for post-treatment minimal residual disease(MRD) assessment.
MRD is assessed on Day 45, Month 3, and every 3 months during the first year of follow-up. The primary endpoint of EFS, along with key secondary endpoints of PFS and overall survival (OS), remains blinded. At the data cut, when the 24th patient completed Day 45 MRD assessment,58.3% (7/12) of patients in the Cema-cel arm achieved minimal residual disease (MRD) negativity compared to 16.7% (2/12) in the observation arm.
In addition, at the first MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm, compared with a median increase of 26.6% in the observation arm.
Cema-cel has been generally well tolerated as of the data cutoff, with no serious adverse events related to treatment.
What's Ahead
For further analysis, the study is enrolling across more than 60 sites, and is expected to enrol approximately 220 patients. The firm expects to complete enrolment by year-end 2027, with an Interim Event-Free Survival (EFS) Analysis anticipated in Mid-2027 and primary EFS in Mid-2028.
CMO Comments
"These interim data suggest that an off-the-shelf CAR T may be able to intervene during that important window before clinical relapse to eliminate residual disease and make earlier intervention feasible in routine clinical practice," said Zachary Roberts, Research and Development and Chief Medical Officer of Allogene.
Allogene develops allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease.
ALLO has traded between $0.86 and $4.09 over the last year. The stock closed Friday's trade at $2.72.
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