Imugene notches third response in azer-cel BTKi cohort
Imugene Limited (ASX: IMU) has reported a third patient response in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of its ongoing azer-cel Phase 1b clinical trial. The clinical-stage cellular therapy company confirmed the result on 27 July 2026.
The material development centres on the second Follicular Lymphoma (FL) patient treated in the cohort, who achieved a partial response (PR) at the Day 28 assessment. Notably, this patient had previously received and progressed on a BTKi therapy.
Both FL patients treated in the concurrent cohort to date have now responded. The cohort evaluates whether concurrent dosing of azer-cel with a BTKi “may restore or enhance therapeutic activity” in patients who have exhausted this standard treatment.
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What the latest data shows
The update adds a further data point to an early-stage cohort. According to Imugene, the key results to date include:
The first complete response in the BTKi cohort was recorded by a Follicular Lymphoma patient at Day 28, establishing the initial efficacy signal that the current result now extends to a third response across five patients dosed.
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A third response achieved in the concurrent BTKi cohort
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A second FL patient recording a partial response at Day 28, having previously received and progressed on BTKi therapy
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Both FL patients in the cohort responding to concurrent treatment with azer-cel and a BTKi
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5 patients dosed to date in the concurrent BTKi cohort
The company also noted that treatment with azer-cel, lymphodepletion and IL-2 has produced meaningful clinical responses across multiple indications, including multiple complete responses in the concurrent BTKi cohort. Each additional response builds the early signal supporting the concurrent-dosing rationale.
Paul Hopper, Executive Chairman of Imugene
“An additional response in the concurrent BTKi cohort, and the second in Follicular Lymphoma, adds to the early signal we are seeing in patients who have progressed on BTKi therapy. Each additional response strengthens our confidence in the rationale for dosing azer-cel concurrently with a BTKi and supports our belief that this approach can address a clear unmet need across a range of blood cancers.”
Why the BTKi resistance market matters
BTK inhibitors (BTKi) are a standard treatment across multiple B-cell malignancies. Despite their established efficacy, a significant proportion of patients develop resistance over time and are left with limited remaining options.
Follicular Lymphoma is the most common indolent B-cell lymphoma. While many patients respond to initial treatment, it remains a high unmet need, with many patients relapsing over time.
All patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy. This defines a specific target population where existing options are limited.
The commercial context is meaningful. According to Imugene, the global BTKi market reached approximately US$12.0 billion in 2025, framing a large, defined addressable market where azer-cel could address unmet need.
What makes azer-cel different
Azer-cel (azercabtagene zapreleucel) is positioned as a differentiated cell therapy. The key features include:
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An off-the-shelf, allogeneic CAR T cell therapy targeting CD19 to treat blood cancers
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Derived from healthy donor T cells and ready for administration within days
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Avoiding the three-to-six week manufacturing lead time required for autologous CAR T products
Trial snapshot
The following table summarises the key features of the ongoing Phase 1b study.
| Trial Feature | Detail |
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| Trial phase | Phase 1b, open-label, multi-centre |
| Geography | 10 US sites and 5 Australian sites |
| Indications | FL, CLL/SLL, MZL, WM, MCL (Non-Hodgkin lymphomas) |
| Concurrent BTKi cohort | Patients who have previously failed BTKi therapy |
| Patients dosed (concurrent cohort) | 5 |
Imugene described the safety profile of the treatment as “manageable and generally well tolerated.”
What comes next for Imugene
Patient enrolment is ongoing across the ten US and five Australian sites. The company stated that further updates will be provided as additional data becomes available and the dataset matures.
For investors, the significance lies in the cumulative signal. Each additional response strengthens confidence in the concurrent-dosing approach across a range of blood cancers, though the cohort remains early-stage with only five patients dosed to date.
Imugene secured dual FDA Fast Track Designation for azer-cel across CLL/SLL and Marginal Zone Lymphoma in June 2026, a regulatory recognition that unlocks more frequent FDA engagement and rolling review eligibility as the broader dataset supporting the off-the-shelf approach continues to mature.
Ready to Follow Azer-cel’s Progress in the Concurrent BTKi Cohort?
Imugene’s Phase 1b trial continues to build an early efficacy signal, with three responses now recorded across five patients dosed in the concurrent BTKi cohort — including both Follicular Lymphoma patients treated to date. The approach targets a defined, high-unmet-need population of patients who have relapsed on or are refractory to BTKi therapy, within a global BTKi market valued at approximately US$12.0 billion.
As enrolment continues across 15 trial sites in the US and Australia, investors can view the full ASX announcements on the Imugene investor centre to stay across the latest trial data as the dataset matures.