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 Commentary: Azer-cel Shows Promising Early Results in DLBCL

The latest data from Imugene’s Phase Ib trial of azer-cel highlights a continued trend of encouraging efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy’s overall response rate has now reached 82%, reflecting a positive signal for this off-the-shelf CAR T-cell approach.

Notably, the addition of interleukin-2 (IL-2) appears to enhance the durability of responses, which could address a key limitation of existing CAR T therapies. The trial’s expansion to CAR T-naïve patients and multiple non-Hodgkin’s lymphoma subtypes underscores Imugene’s strategy to broaden clinical applicability.

While the complete response (CR) rate is still evolving, the early outcomes support further enrollment and indicate that azer-cel may offer a viable alternative to autologous CAR T therapies, especially given its potential to reduce manufacturing complexity and treatment delays.

As the study continues across the US and Australia, careful monitoring of response durability and safety will be essential to confirm these promising trends and guide potential regulatory submissions in the future.

Sources:

• Imugene announces Phase Ib azer-cel efficacy data