Imugene Limited (ASX: IMU) Announces Positive Azer-cel Efficacy Results in CAR T-Naïve Lymphoma Patients
Company: Imugene Limited
ASX Code: IMU
Market Cap: A$107.98 million
Sector: Biotechnology – Cancer Immunotherapies
Imugene Limited (ASX: IMU) has provided an investor update regarding positive early efficacy results from its Phase 1b trial. This ASX announcement demonstrates the Imugene azer-cel efficacy across CAR T-naïve lymphoma patients. The data indicates an 83% overall response rate, with five out of six evaluable patients responding to treatment. Furthermore, three patients (50%) achieved complete responses, where all measurable signs of cancer were no longer detectable.
The clinical-stage immuno-oncology company has treated a total of 10 patients across multiple rare B-cell malignancies. These indications include Primary CNS lymphoma (PCNSL), Waldenström macroglobulinemia (WM), and Marginal Zone Lymphoma (MZL). It is important to note that no CAR T products are currently approved for these indications, which presents a market opportunity.
Patient enrolment is reported to be proceeding at a faster rate compared to previous cohorts. This trend suggests clinical interest in this allogeneic approach. The accelerated patient recruitment may position Imugene to explore an expedited development pathway for azer-cel.
What Characterises the Imugene Azer-cel Efficacy Results?
The Imugene azer-cel efficacy data indicates a positive development in treating heavily pretreated CAR T-naïve patients. These patients had received no prior CAR T therapy, yet demonstrated notable response rates. These rates compare favourably with established autologous treatments.
Key Performance Metrics:
- Overall Response Rate: 83% (5/6 evaluable patients)
- Complete Response Rate: 50% (3/6 patients)
- Treatment Duration: Up to 90+ days of sustained response
- Safety Profile: Manageable and consistent with prior results
| Patient Group | Overall Response Rate | Complete Response Rate | Patient Status |
|---|---|---|---|
| CAR T-Naïve | 83% (5/6 patients) | 50% (3/6 patients) | No prior CAR T treatment |
| CAR T-Relapsed DLBCL | 81% | Multiple CR/PR responses | Failed average 3 prior therapies |
The response durability presents encouraging early signals. Patients have maintained responses ranging from 28+ to 90+ days, with continued follow-up. For context, approved autologous CD19 CAR T products typically require 2-3 months to achieve their best response. Some patients may take up to 6 months.
Chief Executive Officer Leslie Chong stated: “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.”
How Does Allogeneic CAR T Therapy Address Rare Lymphomas?
Allogeneic CAR T therapy offers an approach for treating rare lymphoma subtypes where treatment options are currently limited. The Imugene azer-cel efficacy across multiple rare B-cell malignancies indicates a versatility that extends beyond traditional indications.
Rare Lymphomas Treated in the Trial:
- Primary CNS Lymphoma (PCNSL): Approximately 1,500-1,800 new US cases annually with no approved CAR T products
- Waldenström Macroglobulinemia (WM): Rare slow-growing lymphoma characterised by excess IgM production causing multiple complications
- Marginal Zone Lymphoma (MZL): Slow-growing B-cell lymphoma affecting mucosal sites like stomach and lung
- Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL): Most common slow-growing leukaemia that can become therapy-resistant
- Follicular Lymphoma (FL): Common slow-growing NHL that can transform into aggressive disease
- Diffuse Large B-Cell Lymphoma (DLBCL): Aggressive lymphoma requiring prompt intervention
The allogeneic approach offers notable advantages over traditional autologous CAR T:
- Immediate availability – no patient-specific manufacturing delays
- Standardised quality – consistent product characteristics
- Cost efficiency – reduced manufacturing complexity
- Broader accessibility – serving patients who cannot wait for custom treatments
PCNSL represents an important market opportunity. This rare and aggressive form of non-Hodgkin lymphoma originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. Currently, no CAR T-cell products are approved for treating PCNSL. This may provide a specific opportunity for azer-cel in an indication with high unmet medical need.
How Does Azer-cel Compare to Other CAR T Treatments?
Azer-cel differentiates itself through several key characteristics that position it within the CAR T therapy landscape. Unlike traditional autologous CAR T treatments, azer-cel utilises an off-the-shelf allogeneic approach, providing immediate availability.
| Feature | Azer-cel (Allogeneic) | Traditional CAR T (Autologous) |
|---|---|---|
| Availability | Off-the-shelf, immediate | 2-4 weeks manufacturing time |
| Cost Structure | Lower per-patient costs | High individualised costs |
| Quality Control | Standardised, consistent | Variable patient-dependent |
| Scalability | High – one batch treats many | Limited – one patient per batch |
| Target Indications | Rare lymphomas (unmet need) | Established indications |
Unique Clinical Advantages:
- IL-2 Enhancement: Incorporates Interleukin-2 to extend T-cell survival and enhance cancer-killing functions
- Broad Indication Potential: Treating rare lymphomas with no approved CAR T alternatives
- Manageable Safety Profile: Consistent tolerability across patient populations
- Expedited Development Path: Fast enrolment suggests accelerated regulatory timeline
Interleukin-2 (IL-2) is a critical component of azer-cel’s mechanism. This cytokine supports T-cell growth and survival. It extends their lifespan whilst enhancing the cancer-killing functions of CAR T cells. This biological enhancement aims to make the therapy more effective at targeting and eliminating cancer cells.
The Imugene azer-cel efficacy in the CAR T-relapsed DLBCL portion of the Phase 1b study has achieved an 81% overall response rate to date. Multiple patients achieved complete and partial responses, with several reported to remain in durable remission beyond one year. These patients had typically failed an average of three prior lines of therapy, including autologous CAR T.
What is the Observed Response Durability Compared to Existing Treatments?
The response durability observed in the trial provides encouraging signals regarding the Imugene azer-cel efficacy. Patients have maintained responses ranging from 28+ to 90+ days, with continued follow-up. Follow-up scans are pending for additional patients.
Response Categories Explained:
- Complete Response (CR): All measurable or visible signs of cancer are no longer detectable after treatment
- Partial Response (PR): Significant reduction in tumour size (typically at least 50%) or disease burden, but not complete disappearance
- Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears – a measure of treatment effectiveness in clinical trials
- Durability of Response (DoR): A measure of how long treatment effect lasts, meaning cancer remains controlled for significant periods
For approved autologous CD19 CAR T products, the average time to best response is 2-3 months. Some patients may require up to 6 months to achieve their best response. The current durability data for azer-cel, whilst early, suggests comparable kinetics.
The trial design allows for extended follow-up. This is expected to provide more definitive data regarding long-term response durability. Four additional patients in the CAR T-naïve cohort have follow-up scans pending. These scans are anticipated to further characterise the depth and durability of responses.
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