Allogene Therapeutics, Inc. (NASDAQ:ALLO) shares are up on Monday as the company reported positive interim results from its ALPHA3 trial, which evaluates its investigational CAR T therapy for large B-cell lymphoma.
The trial is evaluating cemacabtagene ansegedleucel (cema-cel), an investigational allogeneic anti-CD19 CAR T therapy, in first-line (1L) consolidation large B-cell lymphoma (LBCL).
Strong MRD Clearance Signals Treatment Potential
The interim analysis from the ALPHA3 trial showed that 58.3% of patients treated with Allogene’s cema-cel achieved molecular residual disease (MRD) clearance, compared to 16.7% in the observation arm.
The update represents 41.6% absolute difference in the cema-cel arm over the observation arm, which exceeded the clinically meaningful benchmark based on the literature of 25-30%.
The trial utilizes Natera Inc.’s (NASDAQ:NTRA) MRD technology to identify high-risk patients, potentially transforming treatment approaches for lymphoma.
In addition, at the Day-45 MRD assessment, 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, suggesting molecular disease progression due to lack of intervention.
The company said these findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD.
Allogene Analyst Sees Results Exceeding Expectations
William Blair on Monday wrote, “These results surpass management expectations of a 25%-30% MRD-clearance difference and achieved our 40% bull case scenario and the level viewed as very meaningful in commentary from our KOLs.”
“In addition, with one-third of patients being infused in community cancer centers, this profile bodes well for broad adoption,” analyst Sami Corwin said on Monday.
The company anticipates an interim Event-Free Survival (EFS) analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, these results could support a Biologics License Application (BLA) submission.
In December 2025, Allogene Therapeutics cited a favorable arbitration outcome for partner Servier in its dispute with Cellectis S.A. (NASDAQ:CLLS) related to cema-cel CAR-T therapy.
The win reconfirmed Allogene’s full development and commercial control of cema-cel in the U.S., the EU, and the U.K., while clearing the path to obtain full global commercialization rights from Servier.
ALLO Price Action: Allogene Therapeutics shares were up 24.08% at $3.37 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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