On October 5, 2026 Imugene Limited (ASX: IMU), a clinical-stage cellular therapy company, reported updated patient data from the BTK inhibitor (BTKi) combination cohort of its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel).
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Four further patients in Cohort 3 reached their Day 28 assessment. Two of the four responded: one Complete Response (CR) in a patient with Mantle Cell Lymphoma (MCL) and one Partial Response (PR) in a patient with Chronic Lymphocytic Leukemia (CLL). Of the other two patients, one with Richter’s Transformation (Diffuse Large B-Cell Lymphoma / Richter’s Transformation, DLBCL/RT) had Stable Disease (SD), and one with Mantle Cell Lymphoma (MCL) had Progressive Disease (PD).
CLL and MCL are high-risk B-cell malignancies where progression on standard BTKi therapies poses a critical clinical challenge. Patients who relapse on or become refractory to BTKi regimens face limited subsequent treatment options and poor overall survival outcomes.
All patients enrolled in this combination cohort have relapsed on or are refractory to prior BTKi therapy. The trial is evaluating whether concurrent administration of azer-cel with a BTKi can enhance antitumor activity in B-cell malignancies. The global BTKi market reached over US$12.0 billion in 2025.
Executive Chairman, Paul Hopper, said: " Observing additional responses in our BTKi combination cohort provides compelling further validation of this strategy. The key here is that we are treating patients who have all progressed on BTK inhibitors and who have high unmet need hematologic cancer with few therapeutic options. With the combination of azer-cel and continuation of the BTK inhibitor, we are seeing a high response rate including in challenging tumor types like MCL and CLL."
Cohort 3 adds to the azer-cel Phase 1b study data. Across the Phase 1b study, azer-cel has now demonstrated a 75% Overall Response Rate (ORR) across a total evaluated population of 55 patients. This includes a 68% ORR in CAR T-relapsed/refractory DLBCL (Cohort 1, n=22), a 81% ORR in CAR T-naïve patients (Cohort 2, n=26), and a 71% ORR in the BTKi combination cohort (Cohort 3, n=7). These pooled results reinforce the consistent therapeutic potential of azer-cel across diverse, difficult-to-treat patient populations. Further clinical updates will be reported as patient enrolment continues and data matures.
Azer-cel is an off-the-shelf, allogeneic CAR T cell therapy targeting CD19 for the treatment of blood cancers. Derived from healthy donor T cells, azer-cel is available for administration within days, bypassing the three-to-six-week manufacturing delay characteristic of autologous CAR T products.
About the Phase 1b azer-cel trial
The ongoing, open-label Phase 1b trial of azer-cel in the U.S. and Australia evaluates three main patient populations: CAR T-relapsed patients, CAR T-naïve patients, and BTKi combination cohort of patients with B-cell malignancies who previously progressed on BTKi therapy. Across a broad range of non-Hodgkin lymphomas (including FL, CLL/SLL, MZL, WM, and MCL), treatment with azer-cel, lymphodepletion, and IL-2 has yielded meaningful clinical activity including multiple complete responses in the BTKi cohort, with a manageable safety and tolerability profile.
(Press release, Imugene, OCT 5, 2026, View Source [SID1234673182])