Imugene Ltd (ASX:IMU) has reported another uplift in efficacy data from its Phase 1b trial of azer-cel, its allogeneic, off-the-shelf CD19 CAR-T therapy, with the overall response rate (ORR) rising to 82% following an additional partial response.
The result means 14 of 17 evaluable patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) have now achieved either a complete or partial response to treatment — a meaningful outcome in a patient group that has typically failed at least three prior lines of therapy, including autologous CAR-T.
Additional patient response strengthens efficacy signal
Imugene had previously reported an ORR of 81% (13 of 16 patients) in September. With one more patient now evaluable and achieving a partial response at the Day 28 scan, the ORR has edged higher and continues to mature as more patients move from partial to complete responses.
Read more: Imugene lifts response rate to 81% in azer-cel CAR T Phase 1b trial
The company said seven patients have achieved complete response to date, while durability continues to deepen across the cohort, including in those treated with the combination of azer-cel, lymphodepletion and interleukin-2 (IL-2). Average time to best response is one to three months.
Notably, Imugene highlighted that the first patient treated in 2024 remains cancer-free after more than 19 months, while others have shown durable responses at five, seven and 15-plus months.
Addressing the limits of current CAR-T therapies
Azer-cel is designed to overcome known limitations of approved autologous CAR-T products, particularly manufacturing complexity, turnaround time and restricted access to specialist treatment centres.
As an off-the-shelf therapy, it aims to broaden availability and reduce delays for heavily pre-treated patients with high unmet need. Around 60% of patients treated with approved autologous CD19 CAR-T therapies ultimately relapse.
Imugene is actively enrolling at 10 trial sites in the US, with up to six Australian sites planned. The first Australian patient, dosed in January at Royal Prince Alfred Hospital in Sydney, achieved a complete response.
Expansion into CAR-T naïve niche indications
The Phase 1b trial has also expanded to treat CAR-T-naïve patients across a broader range of non-Hodgkin lymphomas, including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia and follicular lymphoma.
Early data from these cohorts remains encouraging, with evidence of clinical activity and manageable safety. Imugene noted that PCNSL — a rare but aggressive lymphoma with around 1,500 to 1,800 US cases per year — currently has no approved CAR-T options, positioning azer-cel as a potential first-in-class therapy if ongoing results continue to hold.
Durability and safety profile continue to mature
Alongside response rates, the company emphasised emerging durability trends, particularly in patients receiving IL-2 to support CAR-T persistence and activity. The safety profile remains manageable and generally well tolerated, consistent with earlier updates.
A positive meeting outcome with the US Food and Drug Administration is expected to follow, with Imugene preparing for further trial advancement as it builds its allogeneic CAR-T program.
Azer-cel forms part of Imugene’s broader immuno-oncology pipeline, which also includes its CF33 oncolytic virotherapy platform and additional solid-tumour CAR-T developments.