On October 28, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first efficacy results from the CAR T-naïve niche indication portion of its ongoing Phase 1b trial of azer-cel (azercabtagene zapreleucel) — an off-the-shelf, allogeneic CD19 CAR T therapy being evaluated across a spectrum of B-cell lymphomas.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Of six evaluable CAR T-naïve patients (patients with no previous CAR T treatment), five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending.
A total of ten patients have been treated in this cohort thus far, with further results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably WM, MZL and PCNSL — areas of significant unmet clinical need where no CAR T products are currently approved.
Azer-cel continues to demonstrate a manageable safety profile consistent with previously reported results in relapsed diffuse large B-cell lymphoma (DLBCL). Importantly, enrolment into the CAR T-naïve expansion is proceeding significantly faster than the earlier CAR T-relapsed DLBCL cohort, reflecting the substantial clinical demand and investigator enthusiasm for an allogeneic approach.
Imugene has an FDA Type C meeting in November to discuss pivotal study design options for azer-cel in CAR T-relapsed DLBCL, while also advancing the CAR T-naïve program to generate a broader evidence base across additional indications, including rare lymphomas to expand registrational options.
Chief Executive Officer Leslie Chong said "We are encouraged by these early signals of efficacy in the CAR T-naïve population, with at least five of the first six evaluable patients responding to treatment. As best responses can be seen up to 90 days or more after treatment, we look forward to further data on the depth and durability of these outcomes. Enrolment in this portion of the trial is proceeding at a remarkable pace, positioning us to explore an expedited development pathway for azer-cel."
In the CAR T relapsed DLBCL portion of the same Phase 1b study, azer-cel has achieved an 81% overall response rate to date, including multiple complete and partial responses, with several patients remaining in durable remission beyond a year. Patients in this cohort had typically failed an average of three prior lines of therapy, including autologous CAR T. These findings reinforce azer-cel’s potential as an allogeneic alternative for patients who relapse following existing CAR T treatments and complement the strong early data now emerging in the CAR T-naïve setting.
(Press release, Imugene, OCT 28, 2025, View Source [SID1234657074])