Four of Seven Patients Achieve Complete Response with Azer-cel in Phase 1b Trial

• Four of seven patients in Cohort B achieved complete responses
• Patients had failed 4-5 prior therapies including autologous CAR T
• Longest ongoing response durability at 10 months
• Trial enrolling across 13 US and 5 Australian sites
• Poster presentation at 2025 ASTCT Tandem Meetings highlights data

Promising Clinical Progress in Relapsed/Refractory DLBCL

Imugene Limited (ASX: IMU) has unveiled encouraging new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel), an allogeneic off-the-shelf CD19 CAR T-cell therapy, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The latest results reveal that four out of seven evaluable patients in Cohort B have achieved complete responses (CRs), translating to a 57% CR rate in a patient population with limited treatment options.

DLBCL is a fast-growing and aggressive form of non-Hodgkin's lymphoma, with many patients relapsing after standard therapies, including autologous CAR T-cell treatments. The fact that all four complete responders had previously failed four to five lines of therapy, including autologous CAR T, underscores azer-cel’s potential to address a significant unmet medical need.

Durability and Safety Profile Under Continued Evaluation

While the trial is ongoing, the durability of responses is already notable, with the longest complete response sustained for over 10 months and counting. This durability is critical in assessing the long-term benefit of azer-cel, especially in a patient group where relapse rates remain high. The safety profile reported so far is manageable and generally well tolerated, further supporting the therapy’s clinical viability.

Imugene’s approach combines azer-cel with lymphodepletion chemotherapy and low-dose subcutaneous interleukin-2 (IL-2), which appears to enhance the pharmacokinetic profile of the CAR T cells without compromising safety. IL-2 is known to promote T-cell survival and function, potentially boosting the anti-cancer activity of the therapy.

Expanding Trial Footprint and Upcoming Data Presentations

The Phase 1b trial is actively enrolling patients across 13 sites in the United States and up to five sites in Australia, reflecting Imugene’s commitment to advancing this therapy through rigorous clinical evaluation. The company plans to continue enrolling in Cohort B and closely monitor the long-term durability of responses.

Imugene recently presented a poster at the 2025 ASTCT Tandem Meetings, a leading event in transplantation and cellular therapy, highlighting the enhanced pharmacokinetics and early clinical activity of azer-cel combined with IL-2. This exposure to the broader scientific community will be pivotal in validating the therapy’s potential and attracting further interest.

Strategic Implications for Off-the-Shelf CAR T Therapies

Azer-cel’s allogeneic, off-the-shelf design addresses key limitations of autologous CAR T therapies, such as manufacturing delays and accessibility challenges. If successful, it could represent a more scalable and timely treatment option for patients with aggressive blood cancers. Imugene’s progress thus far positions it as a noteworthy player in the evolving CAR T landscape, where competition and innovation are intensifying.

Looking ahead, the maturation of clinical data and further trial results will be critical in determining azer-cel’s place in the treatment paradigm for DLBCL and potentially other CD19-positive malignancies.

Bottom Line?

As azer-cel’s data matures, Imugene stands at a pivotal juncture to redefine CAR T therapy accessibility for hard-to-treat lymphoma patients.

Questions in the middle?

• How durable will the complete responses remain beyond 10 months?
• What will the broader safety profile look like as more patients are treated?
• Can azer-cel’s off-the-shelf model overcome manufacturing and access hurdles faced by autologous CAR T therapies?