Imugene Limited (ASX: IMU), an Australia-based, clinical-stage immuno-oncology company, announced on Monday new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/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. Since then, two additional patients have also achieved a CR, and three patients have achieved Partial Response (cancer reduction by at least 50 percent) bringing the best overall response rate to 75 percent and the CR rate to 55 percent. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2).

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, Imugene plans to request a Type B (End of Phase 1) Meeting with the US FDA in Q4 2025, to present the data and to discuss designs for a pivotal / registrational trial for azer-cel.

The FDA Fast Track Designation for DLBCL 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.

Imugene continues to 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 CR.