Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company focused on developing novel cancer immunotherapies, today reported further promising patient data from the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of its ongoing Phase 1b basket study for azer-cel (azercabtagene zapreleucel). Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy designed to target CD19 for the treatment of blood cancers. The company announced an additional patient, representing the first Mantle Cell Lymphoma (MCL) patient treated in the study, achieved a complete response at the Day 28 assessment. This patient had previously received and failed BTKi therapy, highlighting the significance of this development for a population with limited remaining treatment options.
Mantle Cell Lymphoma is an aggressive B-cell non-Hodgkin lymphoma, and while BTK inhibitors have become an established treatment for relapsed or refractory MCL, a substantial proportion of patients eventually develop resistance or intolerance. This progression leaves these patients with few viable alternatives. The concurrent BTKi cohort of the azer-cel trial specifically evaluates whether combining azer-cel with a BTKi can restore or enhance therapeutic activity in patients who have relapsed on or are refractory to BTKi therapy. The global BTKi market reached an estimated US$12.0 billion in 2025.
Leslie Chong, Managing Director and CEO of Imugene, commented, “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.” She added that given the broad use of BTK inhibitors across B-cell malignancies and the limited treatment options post-progression, this concurrent dosing approach represents a highly promising clinical and commercial opportunity. To date, four patients have been dosed in this cohort, with two evaluable patients both achieving complete responses. Patient enrolment is ongoing across ten US and five Australian sites.
