Imugene Delivers Promising Phase 1b Results for Azer-cel CAR T Therapy in DLBCL

Imugene Reports Promising Data from Phase 1b Clinical Trial of Azer-cel

Imugene Limited, a clinical-stage immuno-oncology company, recently announced exciting data from its Phase 1b clinical trial, which evaluated the azer-cel (azercabtagene zapreleucel) therapy targeting diffuse large B-cell lymphoma (DLBCL). This aggressive form of blood cancer presents significant treatment challenges, particularly for patients who have undergone multiple lines of prior therapies without success.

Since the last update in February 2025, where initial data indicated encouraging responses, an additional five patients have been enrolled in the trial. The latest results depict two complete responses (CR) and three partial responses (PR), culminating in an impressive overall response rate (ORR) of 75%. Notably, among the 12 evaluable participants receiving the combination of lymphodepletion and azer-cel with interleukin-2 (IL-2), six demonstrated a complete response to the treatment, establishing a CR rate of 55%.

The ongoing study showcases that one of the initial patients remains cancer-free even 15 months post-treatment, with other participants reporting durable responses that have continued for up to 11 months. The trial is particularly crucial as all patients had previously undergone at least three treatment regimens, many facing relapses despite having received as many as six lines of therapy, emphasizing the dire need for innovative treatment options in this high-unmet-need population.

Given these promising results, Imugene eagerly anticipates engaging with the U.S. Food and Drug Administration (FDA) for a Type B meeting in Q4 2025, to discuss the design of a pivotal clinical study for azer-cel, which has also been designated with FDA Fast Track status for DLBCL.

The Phase 1b trial has not only provided essential data regarding azer-cel's efficacy but has also opened opportunities to study its application in CAR T-naïve patients across a broader spectrum of lymphoma types, including primary central nervous system lymphoma (PCNSL) and other B-cell subtypes. These expansions signal a commitment to addressing the critical needs of patients who have limited treatment options available.

Details of the Phase 1b Trial

Imugene's azer-cel trial is an ongoing, open-label, multicenter study primarily based in the U.S. and Australia, focusing on patients with relapsed or refractory DLBCL. The treatment strategy combines azer-cel, an allogeneic CAR T product designed to be used off-the-shelf, with lymphodepletion and IL-2. This unique approach is aimed at overcoming current limitations associated with autologous CAR T therapies, which often involve lengthy production times and complicated logistical challenges.

The safety profile of azer-cel indicates manageable side effects, and the early evidence of clinical activity underscores the potential for this therapy to significantly change outcomes for patients suffering from this aggressive cancer type. Leslie Chong, Managing Director and CEO of Imugene, expressed her enthusiasm about the progress saying, “We are very pleased with the continued positive data coming from the azer-cel trial. This reinforces its potential as a treatment for DLBCL patients who have failed multiple previous lines of therapy.”

As the company prepares to expand its patient enrolment further, it remains focused on the urgency of responding to the high need for better treatment options in the realm of blood cancers. With measures like the FDA Fast Track designation, Imugene is positioned to accelerate the azer-cel program, encouraging hope among patients and healthcare providers.

The Horizon Ahead

As the trial continues, additional updates regarding the outcomes of azer-cel, including its potential efficacy against other lymphoma categories, can be anticipated. Imugene's commitment to innovation in immunotherapy reflects the ongoing drive to enhance the care landscape for those affected by severe, complex malignancies, thereby transforming lives through advanced medical treatment.

In conclusion, Imugene’s developments with azer-cel represent a significant advancement in the fight against DLBCL, exemplifying the important strides being made in cancer therapeutics. The anticipation of forthcoming data and regulatory conversations reflects a cautious optimism that could redefine treatment paradigms for patients grappling with this challenging disease.