Allogene Therapeutics (NASDAQ:ALLO) expects to complete enrollment in its ALPHA3 lymphoma trial by the end of 2027, as increased screening and activity in Asia-Pacific help support recruitment, executives said on the company’s third-quarter earnings call.
The company also plans to present expanded data on its experimental autoimmune therapy ALLO-329 on November 9 at the American College of Rheumatology annual meeting. The update will include additional patients, longer follow-up, three cell dose levels and three conditioning approaches.
President and CEO Zachary Roberts said Allogene remains encouraged by the safety profiles observed so far in both programs, while emphasizing that the ALPHA3 trial’s planned mid-2027 analysis may not result in an unblinding of the data.
ALPHA3 Enrollment and Interim Analysis
ALPHA3 is evaluating cema-cel, an off-the-shelf CAR-T therapy, in patients with lymphoma who have minimal residual disease, or MRD, after first-line treatment. Allogene’s strategy is to identify patients at risk of relapse before their disease returns clinically and treat them in a frontline consolidation setting.
Roberts said an earlier interim futility analysis showed rapid MRD clearance, a favorable early safety profile and the feasibility of administering cema-cel at community practices, including sites without prior CAR-T experience. He said the company continues to screen and treat patients in outpatient and community settings and is preparing to add more community practices.
Recruitment has improved in recent months as screening increased and sites became more productive, Roberts said. Sites in Korea and Australia began screening and enrolling around mid-summer, and patients entered the trial quickly after those sites were activated. He expects Asia-Pacific to account for a relative minority of overall enrollment.
Allogene continues to anticipate a clinical update in mid-2027. Roberts said only a small amount of statistical alpha is allocated to that early look at the trial’s primary endpoint, event-free survival. The independent data safety monitoring board could recommend keeping the data blinded and continuing the study, he said.
“The risk to trial integrity of premature disclosure of interim data is something that we take very seriously,” Roberts said. He added that the company’s priority is completing enrollment without jeopardizing the study’s registrational quality.
ALLO-329 Data to Include Different Conditioning Approaches
Allogene is studying ALLO-329 in the Phase 1 RESOLUTION trial across autoimmune diseases. The therapy was designed with the company’s DAGGER technology to address rejection of allogeneic cells and potentially reduce the need for chemotherapy-based lymphodepletion.
Roberts said Allogene has observed no high-grade toxicities or cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, known as IEC-HS, with ALLO-329 to date. The company incorporated monitoring and management guidance into the RESOLUTION protocol after its experience with inflammatory toxicities in the ALLO-316 program, he said.
During the question-and-answer session, a Goldman Sachs analyst asked about serious adverse events in two patients at the second dose level. Roberts deferred details until the data presentation but said the company had not seen anything concerning so far across cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome or infections.
The upcoming presentation will include results from patients who received no lymphodepletion, Cytoxan alone or a combination of fludarabine and Cytoxan, Roberts said. He cautioned that the cohorts opened at different times, so the data will not be uniform across all three approaches. Allogene aims to assess whether the therapy can provide meaningful activity with less chemotherapy and potentially lower treatment burden.
Scleroderma has been the most active enrollment pathway in the trial’s basket design, Roberts said. The upcoming presentation will focus on patients with diffuse cutaneous systemic sclerosis, while patients with lupus and myositis remain eligible. He said the trial’s design has not changed and that the scleroderma subgroup is the most mature so far.
Frontline Competition and Finance Leadership
Asked about emerging first-line lymphoma regimens, Roberts said they could improve outcomes but predicted their complexity and potential toxicity would limit broad use. He said Allogene does not expect them to have a major impact on the company’s potential market in frontline consolidation, while noting that the full data from one recently reported study were not yet available.
The company also plans to present a survey of 152 U.S. hematologists and oncologists on barriers to CAR-T adoption at the American Society of Hematology meeting.
Roberts recognized Chief Financial Officer Geoff Parker, who is retiring the day after the call. Allogene’s search for a new CFO continues. In the meantime, Roberts said the company has confidence in its financial operations under Annie Yoshiyama, senior vice president of finance, corporate controller and principal accounting officer.
About Allogene Therapeutics (NASDAQ:ALLO)
Allogene Therapeutics, Inc is a clinical-stage biotechnology company focused on developing allogeneic, or “off-the-shelf,” CAR T cell therapies for cancer. Unlike conventional autologous CAR T treatments, which are manufactured from an individual patient’s own cells, Allogene’s approach uses healthy donor cells that can potentially be produced in advance and administered more quickly.
The company’s investigational pipeline has included cemacabtagene ansegedleucel (cema-cel, formerly ALLO-501A) for certain patients with large B-cell lymphoma, as well as other allogeneic CAR T candidates being studied in blood cancers such as multiple myeloma and in solid tumors, including renal cell carcinoma.
