Imugene reveals results of Phase Ib azer-cel efficacy study

Imugene has revealed additional encouraging efficacy findings from its ongoing Phase Ib trial investigating azer-cel (azercabtagene zapreleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy is being developed as an off-the-shelf CAR T-cell treatment, designed to overcome challenges associated with existing autologous CAR T therapies, including complex manufacturing, limited access to treatment centers, and delays in therapy delivery.

The open-label, multi-center Phase Ib study, conducted in both the US and Australia, is assessing azer-cel in DLBCL patients who have relapsed after previous CAR T therapy. The trial has recently been expanded to include CAR T-nave patients with various non-Hodgkins lymphomas, such as chronic lymphocytic leukemia, primary central nervous system lymphoma, and Waldenstrom macroglobulinemia.

In September 2025, Imugene reported that 13 out of 16 participants achieved an overall response rate (ORR) of 81%, categorized as either complete or partial responses. Subsequently, an additional patient became evaluable and showed a partial response at the day 28 assessment, raising the ORR to 82%, with 14 of 17 participants responding to the treatment. The complete response (CR) rate is evolving as more participants are enrolled and some patients transition from partial responses to complete responses.

Imugene noted that patients receiving azer-cel in combination with interleukin-2 (IL-2) are exhibiting increasingly durable responses. Currently, the company is enrolling participants across ten trial sites in the US, with plans to expand to six sites in Australia. The first Australian patient received azer-cel treatment in January 2025 at Royal Prince Alfred Hospital in Sydney.

Author: Sophia Brooks