Australian company Imugene (ASX:IMU) has released new clinical data showing an 82 per cent overall response rate in its Phase 1b trial of azer-cel, the company’s allogeneic, off-the-shelf CD19 CAR T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The updated results include seven complete responses and seven partial responses, with an additional patient achieving a partial response at day 28, raising the best overall response rate to 14 of 17 patients.
The company said the trial continues to demonstrate durable responses across multiple patients, including the first individual dosed in 2024 who remains cancer-free for more than nineteen months, while others have maintained responses at five, seven and fifteen months or longer.
According to the update, most participants had previously failed at least three lines of therapy, many four to six, including autologous CAR-T, underscoring the unmet need in this population.
Imugene is positioning azer-cel as a potential alternative to autologous CAR-T therapies, which require complex, personalised manufacturing. Azer-cel is designed to be delivered on demand, removing geographic and logistical barriers that can delay treatment.
“The durability of response is also deepening,” the company reported, highlighting ongoing treatment activity when combined with lymphodepletion and interleukin-2.
The multi-centre study is enrolling patients across 10 sites in the United States, with up to 6 Australian sites to be added. The first Australian patient, treated at Royal Prince Alfred Hospital in Sydney in January 2025, achieved a complete response. The trial has also expanded to include CAR-T-naïve patients across other difficult-to-treat non-Hodgkin lymphoma subtypes, including PCNSL, CLL/SLL, marginal zone lymphoma, Waldenström macroglobulinemia and follicular lymphoma.
Imugene said safety remains manageable and generally well tolerated, with durability data continuing to mature as more patients are enrolled and followed. A positive FDA meeting outcome will be reported separately, according to the announcement.
The company describes azer-cel as part of its broader immuno-oncology pipeline aimed at harnessing the immune system to target cancer. “Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments,” added the company.