Imugene’s Blood Cancer Drug Hits 81% Response Rate Ahead of ASCO Presentation
Imugene’s azer-cel posts 81% overall response rate in CAR T naïve patients ahead of ASCO 2026 oral presentation
Imugene Limited (ASX: IMU) has published its Phase 1b clinical abstract at ASCO 2026, reporting an 81% overall response rate (ORR) across 16 evaluable CAR T naïve patients with relapsed or refractory blood cancers. The data, now available as Abstract #7012 on the ASCO website following the lifting of the conference embargo, precedes a live oral presentation scheduled for 29 May 2026 at 1:00 PM CDT in Chicago.
The abstract covers 19 patients enrolled across multiple B-cell malignancies, with 16 evaluable at their first disease assessment at Day 28. The patient cohort was heavily pre-treated, with several individuals having received prior bispecific antibodies and autologous stem cell transplant, and carried a median age of 59 years (range 56–73). Dr Supriya Gupta of the University of Minnesota will present the updated dataset in person at the Rapid Oral Abstract Session covering Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia.
When big ASX news breaks, our subscribers know first
Response rates across six blood cancer subtypes
What the data shows
Among the 16 evaluable patients, azer-cel produced responses across six distinct blood cancer subtypes. Complete responses (CR) refer to the disappearance of all detectable cancer, while partial responses (PR) indicate a meaningful but incomplete reduction in disease burden.
| Indication | Patients Evaluable | CR | PR | Response Rate |
|---|---|---|---|---|
| DLBCL | 5 | 1 | 2 | 60% |
| MZL | 4 | 3 | 1 | 100% |
| CLL | 3 | 0 | 3 | 100% |
| PCNSL | 2 | 0 | 1 | 50% |
| FL | 1 | 1 | 0 | 100% |
| WM | 1 | 0 | 1 | 100% |
DLBCL = diffuse large B-cell lymphoma; MZL = marginal zone lymphoma; CLL = chronic lymphocytic leukemia; PCNSL = primary central nervous system lymphoma; FL = follicular lymphoma; WM = Waldenström macroglobulinemia.
Safety and CAR T-cell expansion
The abstract also reported robust CAR T-cell expansion alongside a manageable safety profile, both of which are considered supportive signals for continued clinical development. These characteristics are particularly relevant given the heavily pre-treated nature of the enrolled population.
Understanding allogeneic CAR T therapy and why azer-cel’s approach matters
CAR T therapy involves engineering a patient’s or donor’s immune cells to carry a Chimeric Antigen Receptor (CAR), a synthetic protein that directs those cells to identify and destroy cancer cells expressing a specific target. In azer-cel’s case, that target is CD19, a protein found on the surface of B-cells across a broad range of blood cancers, including all six indications evaluated in this study.
Conventional CAR T therapies are autologous, meaning they are manufactured using the patient’s own cells. This approach requires a lengthy and individualised manufacturing process, which can delay treatment by weeks. Allogeneic therapies, by contrast, use donor cells to create an “off-the-shelf” product that can be produced in advance and administered more rapidly, offering meaningful advantages in both accessibility and scalability.
The patients enrolled in this cohort were CAR T naïve, meaning they had not previously received any form of CAR T therapy. This represents a broad addressable population and positions azer-cel as a potential earlier-line option rather than a last-resort treatment.
Dr John Byon, Chief Medical Officer
“Our ASCO 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.”
Leslie Chong, Managing Director and CEO
“We are excited to showcase these highly encouraging results during our oral presentation at ASCO 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 next major ASX story will hit our subscribers first
What comes next — BTKi combination cohort and the path forward
Cohort 3 opens with BTKi combination arm
Imugene has recently opened Cohort 3 of the Phase 1b protocol, evaluating azer-cel in combination with a Bruton Tyrosine Kinase inhibitor (BTKi). BTKis are an established standard of care across multiple B-cell malignancies, including CLL, MCL, MZL, and WM, and the global BTKi market reached approximately US$12.0 billion in 2025. Cohort 3 also adds Mantle Cell Lymphoma (MCL) as an indication and targets patients who have previously failed BTKi therapy, a population with limited remaining treatment options.
Key upcoming catalysts
Investors should watch the following near-term milestones:
- 29 May 2026, 1:00 PM CDT: Oral presentation by Dr Supriya Gupta at the ASCO Annual Meeting, Chicago (Rapid Oral Abstract Session — Hematologic Malignancies: Lymphoma and CLL)
- An updated dataset is expected to be presented, incorporating more mature data than the published abstract
- The full presentation will be made available at imugene.com/investors/conference-presentations following the session
- Abstract #7012 is available now at asco.org/abstracts (DOI: 10.1200/JCO.2026.44.16_suppl.7012)
The oral presentation on 29 May represents a near-term catalyst event, with updated data from a maturing basket study to be delivered before a global audience of oncology specialists and potential pharmaceutical partners. With Cohort 3 already underway, the addressable indication set continues to expand, broadening the potential clinical and commercial case for azer-cel as development progresses.
Don’t Miss the Next ASX Healthcare Breakthrough
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis. Join 20,000+ investors who never miss a market-moving announcement. Click the “Free Alerts” button at Big News Blast to start receiving real-time alerts the moment news breaks.