Azer-cel Achieves 81% Overall Response Rate in Phase 1b Trial

Strong Clinical Activity Across Blood Cancer Subtypes

Imugene Limited (ASX:IMU) has revealed promising Phase 1b data for its off-the-shelf allogeneic CAR T-cell therapy, azer-cel, showing an 81% overall response rate (ORR) in a CAR T-naïve cohort of 16 evaluable patients with relapsed or refractory CD19-positive B-cell malignancies. The results, published as Abstract #7012 on the American Society of Clinical Oncology (ASCO) website, cover a basket of blood cancers including diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), primary central nervous system lymphoma (PCNSL), and Waldenström macroglobulinemia (WM).

Responses were particularly notable in MZL, CLL, FL, and WM, each showing a 100% response rate, with complete remissions observed in several cases. DLBCL patients achieved a 60% response rate, while PCNSL patients recorded a 50% response. The median patient age was 59 years, with many having undergone multiple prior therapies, including bispecific antibodies and autologous stem cell transplant.

Safety and Cellular Expansion Support Clinical Strategy

Alongside encouraging efficacy, azer-cel demonstrated robust CAR T-cell expansion and a manageable safety profile, reinforcing Imugene’s confidence in its allogeneic platform. Dr John Byon, Chief Medical Officer, highlighted the significance of these results in heavily pre-treated patients who had not previously received autologous CAR T therapy, describing the findings as "very encouraging" and supportive of their clinical development strategy.

The data build on earlier promising signals from the Phase 1b trial, which has been bolstered recently by a $20 million capital raise to accelerate azer-cel’s clinical program and expand patient cohorts. This funding round was detailed in March and is part of Imugene’s broader push to advance its CAR T pipeline and solidify its position in the competitive cell therapy market $20M capital raise.

Expanding Trial Scope with BTKi Combination

Imugene has also initiated a new cohort (cohort 3) to evaluate azer-cel in combination with Bruton Tyrosine Kinase inhibitors (BTKi), targeting patients who have failed BTKi therapy. This move taps into a substantial global BTKi market, valued at around US$12 billion in 2025, and aims to address unmet needs in mantle cell lymphoma (MCL) and other B-cell malignancies. The combination approach could potentially enhance efficacy in resistant patient populations, marking a strategic expansion of the trial’s scope and therapeutic reach.

Earlier reports from the Phase 1b trial indicated a 100% response rate in CLL/SLL patients and an 80% response in MZL, with the BTKi combination cohort representing a logical next step to build on these strong early signals 100% response in CLL/SLL.

ASCO Presentation to Update Dataset

The full dataset will be presented orally at the ASCO Annual Meeting on 29 May 2026 by Dr Supriya Gupta from the University of Minnesota. This presentation is expected to provide updated insights from the ongoing Phase 1b basket study, potentially refining Imugene’s clinical development focus to indications demonstrating the strongest clinical impact. The visibility at ASCO also positions Imugene to attract attention from global oncology experts, potential pharma partners, and investors, an important milestone for the company’s international profile, according to CEO Leslie Chong.