Just a day after reporting the first complete response in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of its ongoing Phase 1b azer-cel trial, Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) has reported a second complete response, adding momentum to an early clinical signal in patients with limited remaining treatment options.
The latest response was recorded in the first mantle cell lymphoma (MCL) patient treated in the azer-cel Phase 1b study. The patient had previously received and failed BTKi therapy before achieving a complete response at the Day 28 assessment.
Second milestone follows first response
The result comes close after Imugene reported its first complete response in the concurrent BTKi cohort, highlighting a second early response in a patient group that has relapsed on or is refractory to BTKi therapy.
To date, four patients have been dosed in the Phase 1b concurrent BTKi cohort, with two evaluable patients both achieving a complete response. Imugene said further updates would be provided as additional data becomes available and the dataset matures.
Imugene managing director and CEO Leslie Chong said achieving a second complete response in the cohort, including in the first MCL patient treated in the study, further reinforced the company’s 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,” Chong said.
Targeting patients with few remaining options
MCL is an aggressive B-cell non-Hodgkin lymphoma that typically presents at an advanced stage and remains incurable with standard therapies.
BTK inhibitors are an established treatment across relapsed or refractory MCL, but Imugene noted that a significant proportion of patients develop resistance or intolerance over time, leaving them with limited options.
The concurrent BTKi cohort is evaluating whether dosing azer-cel alongside a BTKi may restore or enhance therapeutic activity in this setting. The global BTKi market reached about US$12 billion in 2025.
About the trial and azer-cel
Azer-cel is Imugene’s off-the-shelf, allogeneic CAR T cell therapy targeting CD19 to treat blood cancers. It is derived from healthy donor T cells and can be administered within days, avoiding the three-to-six-week manufacturing lead time required for autologous CAR T products.
The Phase 1b study is an ongoing, open-label, multi-centre clinical trial in the US and Australia for CAR T-relapsed and CAR T-naïve patients with a broad range of non-Hodgkin lymphomas, including follicular lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia and mantle cell lymphoma.
Patient enrolment is ongoing across 10 US and five Australian sites.