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Imugene Limited, a clinical-stage immuno-oncology company, has announced exciting new data from its phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma.
In February 2025, Imugene announced that a total of four out of seven patients had achieved a complete response, defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a complete response, and three patients have achieved Partial Response (cancer reduction by at least 50 per cent) bringing the best overall response rate to 75 per cent and the CR rate to 55 per cent. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2.
Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).
Based on the updated response rate and maturing durability data, as well as having been awarded US FDA fast track designation for diffuse large B-cell lymphoma in March 2025, Imugene will request a Type B (end of phase 1) meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal registrational trial for azer-cel.
Leslie Chong, MD and CEO of Imugene, said: "We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for diffuse large B-cell lymphoma patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the US FDA.
Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel."
Dr John Byon, chief medical officer of Imugene, said: "diffuse large B-cell lymphoma remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment.
We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists."
The US FDA Fast Track Designation for diffuse large B-cell lymphoma received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the US FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria.
Imugene continues to actively enrol patients into the phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.
The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre phase 1b clinical trial in the US and Australia, for CAR T relapsed patients with diffuse large B-cell lymphoma. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia and follicular lymphoma. Treatment with azer-cel, lymphodepletion and interleukin 2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.
Diffuse large B-cell lymphoma is an aggressive and fast-growing type of non-Hodgkin's lymphoma, a type of blood cancer. Diffuse large B-cell lymphoma is the most common type of non-Hodgkin's lymphoma, with approximately 160,000 global cases per year and approximately 30,000 new cases per year in the US.
Relapsed/refractory diffuse large B-cell lymphoma has a high unmet medical need; ~60 per cent of patients treated with approved autologous CD19 CAR T relapse.
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