Cinical-stage immuno-oncology company Imugene (ASX: IMU) has reported positive results from its Phase 1b clinical trial evaluating azer-cel in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Following the previously reported results on 2 September 2024, two additional patients in the previously reported Cohort B – treatment with azer-cel, lymphodepletion (chemotherapy), and interleukin 2 (IL -2) – have now achieved a Complete Response (CR, being the disappearance of all signs of cancer in response to the treatment), bringing the total to four out of seven evaluable patients in this cohort.
“All four Complete Responses in Cohort B were achieved in patients who had failed at least 4 lines of therapy in this hard-to-treat population, including autologous CAR T therapy," said Dr Paul Woodard, Chief Medical Officer of Imugene.
"This suggests that azer-cel, in combination with IL-2, may offer a meaningful therapeutic option where other treatments have not succeeded. We are continuing to monitor these patients for persistence of response, with the longest durability ongoing at 10 months. We look forward to providing further updates as data matures.”
The company remains focused on continuing enrolment in Cohort B and evaluating the long-term durability of responses. Azer-cel is being developed as a potential off-the- shelf CAR T-cell therapy, addressing key limitations of autologous CAR T approaches, including treatment accessibility and manufacturing constraints.
About the Phase 1b azer-cel trial
The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the US and Australia, for patients with DLBCL, an aggressive type of non- Hodgkin’s lymphoma blood cancer (NHL), who relapsed after prior treatment with autologous CAR T therapies.
Treatment with azer-cel, lymphodepletion (LD) and IL-2 in Cohort B is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.
