On October 19, 2026 Imugene Limited (ASX: IMU), a clinical-stage cellular therapy company, reported two further responses in its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel), including one CR in the CAR Tnaïve Cohort 2 and one PR in the Bruton Tyrosine Kinase inhibitor (BTKi) combination Cohort 3.
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In Cohort 2, a patient with marginal zone lymphoma (MZL) achieved CR at their day 28 assessment. Cohort 2 has demonstrated an Overall Response Rate (ORR) of 81%, with 22 of 27 patients achieving a response.
In Cohort 3, a patient with Richter’s Transformation who had previously demonstrated SD has now converted to a PR. Cohort 3 evaluates azer-cel in combination with a BTKi in patients whose disease has progressed on prior BTKi therapy.
Cohort 3 has now demonstrated an ORR of 86%, with six of seven patients achieving a response. All patients enrolled in this combination cohort have previously received and progressed on BTKi therapy, representing a heavily pre-treated population with high unmet medical need and fewer remaining treatment options.
These latest results add to the growing body of clinical evidence supporting azer-cel across diverse B-cell malignancies and patient populations with significant unmet medical need.Further clinical updates will be reported as patient enrolment continues and data matures.
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 19, 2026, View Source [SID1234673549])