On July 1, 2026 Imugene Limited (ASX: IMU), a clinical-stage immunooncology company, reported additional patient data from the concurrent BTK inhibitor (BTKi) cohort of its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel).
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This Mantle Cell Lymphoma (MCL) patient, the first MCL patient treated in the azer-cel Phase 1b study, had previously failed BTKi therapy and achieved a complete response at the Day 28 assessment.
MCL is an aggressive B-cell non-Hodgkin lymphoma that typically presents at an advanced stage and remains incurable with standard therapies. BTK inhibitors have become an established treatment across relapsed or refractory MCL, but a significant proportion of patients develop resistance or intolerance over time, leaving them with limited remaining options.
All patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy, a standard treatment across multiple B-cell malignancies. Despite the established efficacy of BTK inhibitors, a significant proportion of patients develop resistance over time and are left with limited remaining options. This cohort evaluates whether concurrent dosing of azer-cel with a BTKi may restore or enhance therapeutic activity in this setting. The global BTKi market reached approximately US$12.0 billion in 2025.
Leslie Chong, Managing Director and CEO of Imugene, said, "Achieving a second complete response in the concurrent BTKi cohort, including in the first Mantle Cell Lymphoma patient treated in the study, further reinforces our belief in azer-cel’s potential for patients who have progressed on BTKi therapy. Given the broad use of BTK inhibitors across B-cell malignancies and the limited treatment options available following progression, we believe this concurrent dosing approach represents a highly promising clinical and commercial opportunity for azer-cel."
To date, four patients have been dosed in the azer-cel Phase 1b concurrent BTKi cohort, two of which are evaluable, both achieving a complete response. Further updates will be provided as additional data becomes available, and the dataset matures.
Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy which targets CD19 to treat blood cancers. Azer-cel is derived from healthy donor T cells and ready for administration within days, without the three-to-six-week manufacturing lead time required for autologous CAR T products.
About the Phase 1b azer-cel trial
The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has most recently expanded into a concurrent BTKi cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. 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. Additionally, the safety profile is manageable and generally well tolerated.
(Press release, Imugene, JUL 1, 2026, View Source [SID1234669019])