Imugene, a clinical‑stage immuno‑oncology company, has unveiled promising efficacy data from its clinical trial of a highly aggressive blood cancer drug.
The Phase 1b clinical trial is of Azer-cel (azercabtagene zapreleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
In September 2025, the company reported that thirteen out of sixteen patients had achieved an overall response rate (ORR) of 81%, defined as either Complete Response (CR)—the disappearance of cancer signs—or Partial Response (PR), a reduction of at least 50% in tumor burden. Since then, an additional patient has become evaluable, achieving a Partial Response at Day 28, boosting the best ORR to 82%, with fourteen out of seventeen patients responding to treatment.
“The Complete Response rate continues to evolve as enrollment progresses and patients transition from partial to complete response, with an average time to best response seen in one to three months,” the company said. Durability of response is also deepening in patients treated with azer-cel in combination with interleukin-2 (IL-2).
Azer-cel is being developed as a potential allogeneic, off-the-shelf CAR T-cell therapy, designed to overcome limitations of current autologous CAR T treatments, including geographic access, manufacturing complexity, and treatment delays.
Imugene is actively enrolling patients at ten U.S. sites, with up to six sites planned in Australia. The first Australian patient, treated in January 2025 at Royal Prince Alfred Hospital in Sydney, achieved a Complete Response.
The ongoing, open-label, multi-center Phase 1b trial in the U.S. and Australia targets CAR T relapsed patients with DLBCL.
The study has recently expanded to include CAR T naïve patients with a range of non-Hodgkin lymphomas, including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and follicular lymphoma (FL).
“Treatment with azer-cel, lymphodepletion, and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response,” Imugene said.
