On May 22, 2026 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported data from its azer-cel Phase 1b abstract, now published on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website following the lifting of the conference embargo.
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The abstract, titled "Safety and efficacy of Azer-cel, an allogeneic CD19 CAR T for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia not previously exposed to autologous CAR T therapy" reports data from the CAR T-naïve cohort of the ongoing Phase 1b basket study across multiple malignancies.
At the time of the abstract data cut, nineteen patients with relapsed or refractory blood cancers received azer-cel in combination with low-dose IL-2; 16 patients were evaluable for response following their first disease assessment at Day 28. Patients had a median age of 59 years (range 56–73) and included diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), follicular lymphoma (FL) and Waldenström macroglobulinemia (WM). Several patients had received multiple prior therapies, including bispecific antibodies and autologous stem cell transplant.
Among the 16 evaluable patients, the overall response rate (ORR) was 81% (13/16). Responses were observed across multiple lymphoma and leukemia subtypes, including:
• DLBCL: 60% response rate (1 CR [CR], 2 partial responses [PRs])
• MZL: 100% response rate (3 CRs, 1 PR)
• CLL: 100% response rate (3 PRs)
• PCNSL: 50% response rate (1 PR)
• FL: 100% response rate (1 CR)
• WM: 100% response rate (1 PR)
Imugene will present updated data during their oral presentation at ASCO (Free ASCO Whitepaper) on 29May 2026 at 1:00pm. These promising response rates and the broader maturing data package from the basket study informs future clinical development, ensuring we target the specific indications where azer-cel can deliver the strongest clinical impact.
Dr John Byon MD PhD, Chief Medical Officer, commented "Our ASCO (Free ASCO Whitepaper) 2026 abstract supports our clinical strategy and highlights the potential of our off-the-shelf allogeneic 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. We look forward to presenting the updated dataset during our oral presentation at ASCO (Free ASCO Whitepaper) next week."
Leslie Chong, Managing Director and CEO of Imugene, said "We are excited to showcase these highly encouraging results during our oral presentation at ASCO (Free ASCO Whitepaper) next week. This represents an important milestone for Imugene and further increases the Company’s visibility to an international audience, including leading cancer experts, potential pharmaceutical partners and global investors."
The full abstract is available at asco.org/abstracts (Abstract #7012; DOI:
10.1200/JCO.2026.44.16_suppl.7012).
Dr Supriya Gupta, University of Minnesota will present the data in person at the Rapid Oral Abstract Session — Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia, on 29 May 2026 at 1:00 PM CDT at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago. The final presentation will be made available at imugene.com/investors/conferencepresentations following the session.
BTKi Combination Cohort
Imugene has recently opened cohort 3 in the Phase 1b protocol to evaluate azer-cel in combination with a Bruton Tyrosine Kinase inhibitor (BTKi) and added Mantle Cell Lymphoma (MCL) as an indication. The combination arm will enrol patients who previously failed BTKi therapy. BTKis are an established standard of care therapy across multiple B-cell malignancies including CLL, MCL, MZL and WM. The global BTKi market reached approximately US$12.0 billion in 2025.
About Dr John Byon MD PhD, Chief Medical Officer
Dr Byon is an accomplished physician-scientist with extensive experience in clinical development and cancer immunotherapy, particularly in CAR-T cell therapy. Prior to Imugene, Dr Byon served as Vice President, Clinical Development, Hematology at Fate Therapeutics, overseeing a portfolio of CAR-NK and CAR-T therapies for hematologic malignancies including acute myeloid leukemia and multiple myeloma. His career also spans leadership roles at Lyell Immunopharma, Juno Therapeutics, and Genentech. Dr Byon holds a Doctor of Medicine and Doctor of Philosophy from Tulane University and a Bachelor of Science from the Massachusetts Institute of Technology.
(Press release, Imugene, MAY 22, 2026, View Source [SID1234665952])