Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) has reported the first complete response in the concurrent Bruton Tyrosine Kinase inhibitor (BTKi) cohort of its ongoing Phase 1b azer-cel trial, marking an early clinical signal in a patient group with limited remaining treatment options.
The first patient in the cohort, who had follicular lymphoma and had previously failed BTKi therapy, achieved a complete response at the Day 28 assessment.
The result is significant as all patients enrolled in the concurrent BTKi cohort have relapsed on or are refractory to BTKi therapy, which is widely used across multiple B-cell malignancies.
Imugene noted some patients develop resistance to BTK inhibitors over time, leaving them with limited treatment options. The cohort is evaluating whether concurrent dosing of azer-cel with a BTKi can restore or enhance therapeutic activity in this setting.
BTKi therapy addresses a global market valued at about US$12 billion in 2025, highlighting the potential commercial relevance of a successful combination approach.
Four patients dosed so far
To date, four patients have been dosed in the concurrent BTKi combination cohort, including the first patient with mantle cell lymphoma. Imugene said it would provide further updates as more data becomes available and the dataset matures.
Managing director and CEO Leslie Chong said: “This initial data provides further confidence in the potential of azer-cel in patients who have exhausted standard treatment options, including BTK inhibitors. Given how widely BTKi therapies are used, we believe this combination approach could represent a meaningful development pathway for azer-cel.”
About the azer-cel trial
Azer-cel is Imugene’s off-the-shelf, allogeneic CAR T cell therapy targeting CD19 to treat blood cancers. The therapy is derived from healthy donor T cells and is designed to be ready for administration 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 trial in the US and Australia, enrolling CAR T-relapsed and CAR T-naïve patients with a range of non-Hodgkin lymphomas, including follicular lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinaemia and mantle cell lymphoma.
Patient enrolment is ongoing across 10 US sites and five Australian sites.