Allogene Therapeutics (NASDAQ:ALLO) executives said the company’s lead allogeneic CAR-T program remains on track after interim data showed measurable activity in large B-cell lymphoma, while also highlighting early signs of response in its autoimmune pipeline during a fireside chat at the Jefferies 2026 Global Healthcare Conference.
David Chang, Allogene’s outgoing CEO, said the company is entering a transition period from a position of strength. Allogene launched in 2018 at the same Jefferies healthcare conference, he noted, and has since focused on developing allogeneic, or “off-the-shelf,” cell therapies.
Zach Roberts, Allogene’s chief medical officer and incoming CEO, said he joined the company in 2023 after previously working with Chang and other Allogene executives at Amgen and Kite. Chang said Roberts was brought in both to lead clinical programs and eventually succeed him as CEO. Chang said he will remain on Allogene’s board and continue to be involved with the company.
ALPHA3 Data Support Earlier-Line CAR-T Strategy
Roberts said ALPHA3 is testing cema-cel as consolidation therapy for patients with large B-cell lymphoma who remain minimal residual disease, or MRD, positive after first-line treatment. In April, Allogene reported that cema-cel cleared MRD in 58.3% of treated patients, moving them from MRD positive to MRD negative.
Roberts said Allogene expects MRD clearance to translate into event-free survival, or EFS, benefit, based on historical lymphoma data using the same PhasED-Seq test employed in ALPHA3. He cited the TRANSFORM study of Breyanzi in second-line lymphoma, where a 24% improvement in MRD clearance translated into a 63% improvement in EFS risk in the final analysis.
“We believe that we are headed towards a good outcome for this trial,” Roberts said, adding that ALPHA3 reflects years of learning about how best to use CAR-T cells in cancer patients. He said treating patients with low disease burden has generally been associated with better safety and efficacy outcomes.
Chang described ALPHA3 as an effort to improve cure rates after frontline therapy without overtreating patients who are already likely to do well. He said standard frontline treatment cures about 60% of large B-cell lymphoma patients, while ALPHA3 focuses on the remaining patients identified through MRD testing as having residual disease.
Executives Emphasize Outpatient Safety Profile
Allogene executives also highlighted the safety profile observed in the interim analysis. Roberts said most patients in the cema-cel arm were treated and managed as outpatients, with no treatment-related hospitalizations in the interim futility analysis. He said no tocilizumab or steroids were given before or after cema-cel.
Chang said the safety profile is important because ALPHA3 is designed to move CAR-T use beyond specialized centers and into community-based cancer centers where many patients are treated.
Roberts said the study’s primary analysis is currently scheduled for mid-2028 and is statistically designed to show a 50% reduction in the risk of EFS events, or a hazard ratio of 0.5. An interim EFS analysis is planned for mid-2027, though Roberts said Allogene has not disclosed the detailed powering assumptions for that look.
Market Opportunity Linked to MRD Testing
Roberts estimated that about 30,000 patients are diagnosed with large B-cell lymphoma in the United States each year, with most receiving curative-intent first-line therapy. He said Allogene estimates the total addressable market for cema-cel at about $5 billion across the U.S. and EU5.
He said MRD testing is currently used in roughly one in five to one in four patients at the end of frontline treatment, largely to improve prognostic information beyond PET-CT imaging. Roberts said utilization could rise to 75% to 80% if an approved therapy becomes available for patients who test MRD positive.
Based on blinded market research with key opinion leaders and community oncologists, Roberts said Allogene expects 50% to 70% of practitioners would use cema-cel in response to an MRD-positive result. He said that supports a potential launch opportunity of about $2.5 billion to $3.5 billion across the U.S. and EU5.
Autoimmune Program Shows Early Clinical Signals
Chang also discussed ALLO-329, Allogene’s autoimmune candidate targeting CD19 and CD70. He said the dual-targeting approach is designed to address B-cell dysfunction and CD70-positive cells that may contribute to autoimmune disease pathogenesis.
Chang said the company has enrolled nine patients, completing the first two dose levels within four to five months. He said investigators have reported early clinical responses, though Allogene is not yet ready to provide a full analysis of the data.
The company has tested 20 million and 40 million cells and is now testing 80 million cells, Chang said. Allogene plans to provide an update in the fourth quarter that will include longer follow-up and data from patients treated at higher dose levels.
Chang said Allogene’s cash runway extends into the first quarter of 2029, covering the ALPHA3 interim analysis, study completion, primary analysis and potentially a biologics license application submission. He said the company’s main priorities are executing ALPHA3 and advancing ALLO-329, which he described as a potentially significant additional opportunity if the autoimmune data continue to strengthen.
About Allogene Therapeutics (NASDAQ:ALLO)
Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic, or “off-the-shelf,” chimeric antigen receptor T-cell (CAR T) therapies to treat a range of hematologic malignancies and solid tumors. The company leverages gene-editing technologies to generate universally compatible engineered T cells, aiming to overcome the limitations of patient-specific CAR T approaches such as manufacturing delays, variable product quality and treatment resistance.
The company’s pipeline includes multiple allogeneic CAR T candidates targeting key antigens in blood cancers.
