Imugene Ltd (ASX:IMU, OTC:IUGNF) has announced promising new data from its ongoing Phase 1b trial of azer-cel (azercabtagene zapreleucel), an allogeneic, off-the-shelf CAR T-cell therapy targeting relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
The updated results show a continued high overall response rate (ORR), with a total of six Complete Responses (CR) and three Partial Responses (PR) in the trial, bringing the ORR to 75%. These results further reinforce the potential of azer-cel as a treatment option for patients who have previously failed multiple lines of therapy, including autologous CAR T therapies.
Trial highlights and response rates
Since Imugene’s last update on the trial in February, five additional patients have been dosed, bringing the total number of patients to 12. This has resulted in two new CRs and three PRs, bringing the CR rate to 55%, a significant achievement in a high unmet-need patient population.
The first patient in the trial remains cancer-free at 15 months, with other patients showing durable responses at two, five, and 11 months, and more durability data expected in the coming months.
The trial includes patients who have failed at least three prior lines of therapy, with many having failed four to six lines, including autologous CAR T. The data suggests that azer-cel’s ability to induce deep and durable responses is especially promising given the poor prognosis and lack of effective treatment options for patients with advanced DLBCL.
Moving forward: FDA discussions and trial expansion
Imugene intends to meet with the US Food and Drug Administration (FDA) in the fourth quarter of 2025 to discuss the data and the design for a pivotal or registrational study for azer-cel. The company has been granted FDA Fast Track Designation for DLBCL, which is designed to expedite the development and review of drugs that address serious or life-threatening conditions and meet an unmet medical need.
Imugene managing director Leslie Chong said the positive trial data reinforces azer-cel’s potential as a treatment for DLBCL patients who have not responded to other lines of therapy.
“The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA,” she said.
Given the strong results, Imugene is expanding the trial to include patients with other B-cell lymphoma subtypes, such as Primary Central Nervous System Lymphoma (PCNSL) and chronic lymphocytic leukaemia (CLL).
“This is a high unmet need with potential to expedite and expand the scope of azer-cel,” Chong said.
About Imugene and the azer-cel trial
Azer-cel is being developed to address key challenges of current CAR T therapies, such as manufacturing complexity and the time required to produce patient-specific treatments. The therapy is designed to be available "off-the-shelf" and can be administered on-demand, potentially offering greater access to treatment, especially in underserved regions.
The Phase 1b trial is ongoing at multiple sites in the US and Australia, and Imugene continues to actively enrol patients. The study data has been used to support the potential of azer-cel as a treatment for difficult-to-treat lymphoma and other blood cancers, as the company advances toward pivotal trials.