Imugene’s Off-the-Shelf CAR T-Cell Therapy Shows Potent Responses in DLBCL Trial

SYDNEY, July 14, 2025 /PRNewswire/ —  Imugene Ltd has announced promising updated data from its ongoing Phase 1b trial of azer-cel (azercabtagene zapreleucel), an allogeneic, off-the-shelf CAR T-cell therapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

The new results show a continued high overall response rate (ORR) of 75%, with a total of six Complete Responses (CRs) and three Partial Responses (PRs) among 12 patients. The CR rate has increased to 55%. These findings are particularly significant as the trial includes patients who have failed multiple prior lines of therapy, including autologous CAR T treatments, highlighting azer-cel’s potential in a patient population with high unmet need and poor prognosis.

Notable durability has been observed, with the first patient remaining cancer-free at 15 months, and others showing durable responses at two, five, and 11 months.

Moving forward, Imugene intends to meet with the US Food and Drug Administration (FDA) in Q4 2025 to discuss these data and the design for a pivotal or registrational study for azer-cel. The therapy has already been granted FDA Fast Track Designation for DLBCL, aimed at expediting its development and review.

Imugene Managing Director Leslie Chong emphasized that the positive data significantly improves azer-cel’s regulatory and commercial position. Given the strong results, Imugene is also expanding the trial to include patients with other B-cell lymphoma subtypes, such as Primary Central Nervous System Lymphoma (PCNSL) and chronic lymphocytic leukaemia (CLL), to address additional high unmet needs.

Azer-cel is being developed to overcome challenges associated with current CAR T therapies, offering an “off-the-shelf” solution that can be administered on-demand, potentially increasing patient access to treatment. The Phase 1b trial is ongoing in the US and Australia, with active patient enrollment.