On February 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported more positive results from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, FEB 14, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7cb7e5ac-c469-4c73-907d-5e7846ef78e9/Azer_cel_demonstrates_two_additional_Complete_Responses.pdf [SID1234650267]). 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.
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"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.
The 2025 Tandem Meetings event for the Transplantation & Cellular Therapy Meetings of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Marrow Transplant Research) highlights the latest research breakthroughs in hematopoietic cell transplantation (HCT), cellular therapy and gene therapy. Imugene poster presentation at this event takes place at 6:45pm Hawaii Standard Time on 13 February (3:45pm AEDT 14 February) can be viewed at the same time on Imugene’s website at View Source
The poster presentation is titled: Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior CD19-Directed CAR T-Cell Products.
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 U.S. 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.
About diffuse large B cell lymphoma (DLBCL)
DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 80,500 cases per year and approximately 30,000 new cases per year in the U.S.
Relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with approved therapies, including autologous CD19 CAR T, relapse.
About Interleukin 2 (IL-2)
IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.