Clinical-stage immunooncology company Imugene (ASX:IMU) has announced new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment.
The company said that since then, two additional patients have also achieved a CR, 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, it said, adding these patients are being treated with azer-cel and interleukin 2 (IL -2).
Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR-T cell therapy, which could overcome some of the key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment.
Imugene said that based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, it will request a Type B (End of Phase 1) Meeting in the fourth quarter of 2025, with the US FDA to present the data and to discuss designs for a pivotal registrational trial for azer-cel.
Imugene Managing Director and CEO Leslie Chong 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 DLBCL 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 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.”