Imugene’s Off-the-Shelf CAR T Therapy Faces Crucial FDA Meeting After Promising Data
Imugene Limited reports promising Phase 1b trial results for azer-cel, an off-the-shelf CAR T therapy, showing a 75% overall response rate in relapsed diffuse large B-cell lymphoma patients. The company plans to engage the FDA later this year to discuss pivotal trial design.
- 75% overall response rate with 55% complete responses in Phase 1b trial
- Durable responses observed, including one patient cancer-free beyond 15 months
- Trial expanded to include CAR T naïve patients with other lymphoma subtypes
- FDA Fast Track designation secured, pivotal study discussions planned for Q4 2025
- Azer-cel offers off-the-shelf alternative addressing autologous CAR T limitations
Promising Clinical Progress in Aggressive Lymphoma
Imugene Limited (ASX, IMU) has unveiled encouraging new data from its Phase 1b clinical trial of azer-cel, an allogeneic, off-the-shelf CAR T-cell therapy targeting CD19 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Since the company’s last update in February 2025, five additional patients have been treated, resulting in two complete responses and three partial responses. This brings the overall response rate to an impressive 75%, with 55% of patients achieving complete remission.
DLBCL is a notoriously aggressive form of non-Hodgkin lymphoma with limited treatment options for patients who relapse after multiple therapies. Many participants in this trial had failed between three to six prior treatments, including autologous CAR T therapies, underscoring the high unmet medical need that azer-cel aims to address.
Durability and Expansion of Trial Scope
One patient remains cancer-free more than 15 months after treatment, with others showing durable responses at 2, 5, and 11 months and beyond. These results suggest azer-cel’s potential to provide lasting benefit from a single administration, a significant advantage over existing therapies that often require complex manufacturing and longer wait times.
Building on these positive outcomes, Imugene has expanded the trial to include CAR T naïve patients with other niche blood cancers such as primary central nervous system lymphoma (PCNSL) and various B-cell lymphoma subtypes. This strategic move could broaden the therapy’s applicability and accelerate its path to market.
Regulatory Milestones and Future Outlook
In March 2025, azer-cel was granted FDA Fast Track designation for DLBCL, a status that facilitates expedited development and review. Imugene plans to request a Type B meeting with the FDA in the fourth quarter of 2025 to discuss the design of a pivotal registrational trial, a critical step toward potential approval.
CEO Leslie Chong highlighted the significance of these developments, emphasizing the therapy’s promise for patients who have exhausted other options and the improved regulatory and commercial positioning this data provides. The company is actively enrolling patients across multiple sites in the US and Australia, signaling robust momentum in clinical development.
Addressing Limitations of Current CAR T Therapies
Azer-cel’s allogeneic, off-the-shelf nature addresses key challenges faced by autologous CAR T therapies, including manufacturing delays and limited geographic access to treatment centers. By offering an on-demand treatment option, azer-cel could transform the therapeutic landscape for aggressive blood cancers.
As durability data continues to mature and the trial expands, Imugene’s next steps will be closely watched by investors and clinicians alike, eager to see if azer-cel can fulfill its potential as a new standard of care.
Bottom Line?
With durability data strengthening and FDA discussions imminent, azer-cel could soon redefine treatment for aggressive lymphomas.
Questions in the middle?
- How will the FDA respond to Imugene’s pivotal trial design proposals in Q4 2025?
- Can azer-cel maintain durable responses in larger, more diverse patient populations?
- What commercial strategies will Imugene pursue to compete with established CAR T therapies?
