Imugene Ltd (ASX:IMU, OTC:IUGNF, FRA:ILA) has reported encouraging early response rates from the CAR T-naïve cohort of its ongoing Phase 1b azer-cel trial ahead of a major presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The clinical-stage immuno-oncology company said its off-the-shelf allogeneic CAR T therapy delivered an overall response rate of 81% in evaluable patients across a range of relapsed or refractory blood cancers, including chronic lymphocytic leukemia (CLL), marginal zone lymphoma (MZL) and diffuse large B-cell lymphoma (DLBCL).
The newly published ASCO abstract covers data from 19 patients with CD19-positive blood cancers who received azer-cel in combination with low-dose IL-2, with 16 patients evaluable for response following their first disease assessment at Day 28.
Responses across multiple blood cancers
Patients enrolled in the trial had already undergone multiple prior therapies, including bispecific antibodies and autologous stem cell transplants, reflecting the heavily pre-treated nature of the cohort.
Among the strongest early signals were:
- 100% response rates in MZL, CLL, follicular lymphoma (FL) and Waldenström macroglobulinemia (WM);
- a 60% response rate in DLBCL; and
- a 50% response rate in primary central nervous system lymphoma (PCNSL).
Imugene said the data also demonstrated robust CAR T-cell expansion alongside a manageable safety profile, supporting its broader strategy to develop scalable allogeneic cell therapies that can potentially overcome some of the manufacturing and logistical limitations associated with traditional autologous CAR T approaches.
Chief medical officer Dr John Byon said the ASCO abstract reinforced the company’s clinical strategy and highlighted the potential of its off-the-shelf CAR T platform.
“The response rates seen in this CAR T-naïve patient group, particularly in these heavily pre-treated patients across multiple blood cancer types, are very encouraging,” he said.
ASCO presentation draws investor focus
Managing director and chief executive officer Leslie Chong said the ASCO presentation represented an important milestone for the company and would help lift Imugene’s profile among global oncology specialists, investors and potential pharmaceutical partners.
“We are excited to showcase these highly encouraging results during our oral presentation at ASCO next week,” she said.
The updated dataset will be presented during a rapid oral abstract session at ASCO on Friday, May 29, with investors likely to watch closely for durability data, safety updates and any signs of deeper responses as the study matures.
The presentation also continues a period of growing market attention around Imugene’s azer-cel program, following recent broker commentary highlighting the therapy’s commercial potential and broader investor interest in next-generation cell therapies.
Expanding beyond traditional CAR T models
CAR T therapies have become one of the fastest-growing areas in cancer treatment over the past decade, particularly in blood cancers such as lymphoma and leukemia. However, most currently approved CAR T treatments rely on harvesting and re-engineering a patient’s own immune cells — a complex and expensive process that can create delays for critically ill patients.
Imugene’s azer-cel instead uses donor-derived allogeneic cells manufactured in advance, allowing treatment to potentially be delivered off the shelf.
The company is also expanding the study into a new combination cohort evaluating azer-cel alongside Bruton Tyrosine Kinase inhibitors (BTKis), while adding mantle cell lymphoma as an additional target indication.
That move could broaden the commercial opportunity for the therapy across several major B-cell malignancies, particularly given the large and established global BTKi market, which Imugene estimates reached about US$12 billion in 2025.
Chong recently spoke with Proactive about the company’s latest advancements in its allogeneic CAR-T therapy platform, Azer-Cel, and the growing clinical data supporting its potential in difficult-to-treat blood cancers:
