Allogene Therapeutics (NASDAQ:ALLO) outlined progress across its clinical pipeline during its second-quarter 2026 conference call, highlighting expanded enrollment infrastructure for its pivotal ALPHA3 lymphoma study, recent FDA designations for cema-cel, published renal cell carcinoma data for ALLO-316, and plans to report initial data from the ALLO-329 autoimmune program by year-end.
President and Chief Executive Officer Zachary Roberts, speaking on his first quarterly call in the role, said the company’s strategy centers on using the off-the-shelf availability, consistent manufacturing and potential community-based administration of allogeneic CAR T therapies to address settings where those characteristics may provide an advantage.
ALPHA3 Site Network Expands
Allogene had set a goal to activate more than 80 trial sites by year-end, but reached that milestone in July. The company now expects to have approximately 100 active sites by the end of 2026, with most located in the United States and additional sites in Canada, Australia and South Korea.
Roberts said the expanded network includes academic and community-based investigators. He said interest after the trial’s interim futility analysis was balanced between academic centers and community practices, and that community physicians view the study as an opportunity to offer CAR T treatment locally.
The company’s April interim analysis found that cema-cel cleared MRD rapidly in a majority of patients, according to Roberts. He said there were no treatment-related hospitalizations, most patients were managed entirely in outpatient settings, and the therapy was administered successfully at community practices without prior CAR T experience.
Allogene also added an observational cohort of MRD-negative patients to ALPHA3. Roberts said the cohort will provide a prospective reference population to help contextualize outcomes for the randomized MRD-positive patients and further characterize the MRD test.
Despite faster site activation, Allogene maintained its expectation for the trial’s planned interim event-free survival, or EFS, analysis around mid-2027. Roberts said the company is focused on accelerating enrollment but is not changing its timeline for data availability. The trial’s current randomized enrollment target remains 220 patients.
Roberts noted that statistical significance at the interim EFS analysis would require what he called “overwhelming efficacy” because of how the trial’s statistical alpha is allocated between the interim and primary analyses. He cited the prior TRANSFORM study of Breyanzi as an example in which a 24% MRD-clearance difference corresponded with more than a 60% improvement in EFS, while cautioning that Allogene could not provide further estimates on ALPHA3’s likelihood of meeting statistical significance at the interim analysis.
FDA Designations for Cema-cel
At the end of July, the FDA granted regenerative medicine advanced therapy, or RMAT, and Fast Track designations to cema-cel in first-line consolidation. Roberts said the agency’s action reflects its view that MRD-positive large B-cell lymphoma after first-line treatment represents an unmet medical need and that cema-cel may have the potential to address it.
He said the RMAT submission was supported by clinical information from the April interim analysis, including more extensive MRD details and a safety package than the company disclosed publicly. EFS data remained blinded at that point and remain blinded to the company, he said.
Roberts added that RMAT status could facilitate more frequent and focused interactions with the FDA as the ALPHA3 trial advances. Allogene expects potential opportunities to update investors on ALPHA3 enrollment and data in 2027, subject to regulatory discussions and guidance from the independent data monitoring committee.
ALLO-316 Data Published; Autoimmune Update Planned
Allogene also discussed the recent publication of results from the TRAVERSE study of ALLO-316 in the Journal of Clinical Oncology. In patients with CD70-high renal cell carcinoma treated using the optimized regimen, ALLO-316 produced a 31% confirmed overall response rate. At the data cutoff, none of the five confirmed responders had progressed, with follow-up ranging from eight months to more than 18 months after a single dose.
Roberts said the data set was small and acknowledged that the program has faced safety challenges. He said the company worked with outside experts and the FDA to develop a management algorithm for serious events, while continuing to study CAR T expansion, persistence, tumor infiltration and the role of its Dagger technology.
For ALLO-329, which is being evaluated in the RESOLUTION autoimmune trial, Allogene expects to report clinical and translational data in the fourth quarter. The company previously disclosed that nine patients had been treated across lymphodepletion-containing and non-lymphodepletion arms, and Roberts said enrollment has continued to be robust.
The planned update is expected to include safety, efficacy and translational findings. Roberts said the initial dose cohorts of 20 million, 40 million and 80 million cells will be included, while the protocol also contemplates higher dose levels.
Asked about early findings in the lymphodepletion arm, Roberts said the phase 1 study is primarily focused on safety and dose escalation decisions. He said Allogene has observed encouraging signs of activity but was not prepared to discuss translational findings before the fourth-quarter update.
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.
