Two Additional Complete Responses in azer-cel Ph1b trial
Key points
- 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel
- First patient remains cancer free at 15 months and ongoing
- Patients previously failed at least 3 lines of therapy, including autologous CAR-T
Full summary
Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, has announced exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Since the February 2025 update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR), bringing the best overall response rate to 75% and the CR rate to 55%. The first patient remains cancer free at 15 months and ongoing, with additional patients having durable responses at 2, 5, and 11 months+. Patients in the trial have previously failed at least 3 lines of therapy, with many failing 4-6 lines, including autologous CAR-T, reinforcing the potential of azer-cel in this high-unmet-need population. Based on these positive results, Imugene expects to meet with the US FDA in Q4 2025 regarding a pivotal/registrational study for azer-cel. The trial is also now open to enrol into CAR T naïve niche indications in other lymphomas.
Outlook
Imugene expects to meet with the US FDA in Q4 2025 regarding a pivotal/registrational study for azer-cel. The trial is also now open to enrol into CAR T naïve niche indications in other lymphomas.
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