Imugene Limited (ASX: IMU) has reported more positive results from its Phase 1b clinical trial of azer-cel, an allogeneic off-the-shelf CD19 CAR-T therapy, for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). With two more patients achieving Complete Responses (CRs), the trial now boasts a 57% CR rate, a promising result for patients who had previously failed 4-5 lines of therapy, including autologous CAR-T.
Key Takeaways
- Four out of seven patients in Cohort B have now reached Complete Response following treatment with azer-cel, chemotherapy, and low-dose interleukin 2 (IL-2).
- Durability update ongoing, with the longest response still active at 10 months.
- The trial is expanding, with 13 sites in the U.S. and up to 5 in Australia actively enrolling patients.
- Azer-cel is being developed as an off-the-shelf CAR-T therapy, addressing manufacturing and accessibility challenges seen with autologous CAR-T treatments.
- Results featured at the 2025 ASTCT Tandem Meetings, highlighting the potential of IL-2 in enhancing CAR-T efficacy.
A Major Step for Hard-to-Treat Blood Cancer
DLBCL is a fast-growing non-Hodgkin’s lymphoma (NHL) that remains difficult to treat, particularly for patients who relapse after autologous CAR-T therapy. Azer-cel’s ability to elicit a complete response in over half of the treated patients—despite their previous treatment failures—suggests a promising alternative for those with limited options.
What the Experts Are Saying
Dr. Paul Woodard, Chief Medical Officer of Imugene, highlighted the significance of the results:
“All four Complete Responses in Cohort B were achieved in patients who had failed at least four prior lines of therapy, reinforcing the potential of azer-cel in this high-unmet-need population.”
“We are continuing to monitor these patients, and with the longest response ongoing at 10 months, we look forward to providing further updates as the data matures.”
Looking Ahead
With additional enrolment and durability monitoring ongoing, Imugene is focused on solidifying azer-cel’s role as a breakthrough CAR-T therapy. Given the strong early signals and its potential for broader accessibility, azer-cel could reshape the treatment landscape for relapsed/refractory DLBCL patients in the coming years.
