In a strong validation of the company’s clinical trial, Imugene Ltd’s Phase 1b trial for its azer-cel off-the-shelf, allogeneic, CD19 CAR T therapy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) has achieved two more complete responses.
A complete response is the gold standard in cancer treatment, meaning all signs of cancer have disappeared and the patient is in complete remission.
With the latest update, four of the seven patients treated in the trial have now achieved a complete response after being treated with azer-cel, lymphodepletion (chemotherapy), and low-dose interleukin 2 (IL-2).
The patients had previously gone through 4-5 lines of therapy with no success.
Addressing unmet patient needs
“All four Complete Responses in Cohort B were achieved in patients who had failed at least 4 lines of therapy in this hard-to-treat population, including autologous CAR T therapy," Imugene chief medical officer Dr Paul Woodard said.
"This suggests that azer-cel, in combination with IL-2, may offer a meaningful therapeutic option where other treatments have not succeeded.
“We are continuing to monitor these patients for persistence of response, with the longest durability ongoing at 10 months.
“We look forward to providing further updates as data matures.”
Azer-cel is being developed as a potential off-the-shelf therapy, which would make it a much more cost-effective and accessible treatment than other cell therapies, which require a sample of the individual patient’s cells.
The Phase 1b trial is ongoing, with 13 US sites and up to 5 Australian sites moving to actively enrol in the trial.
Poster presentation
IMU will also present its data from the trial at the 2025 Tandem Meetings event for the Transplantation & Cellular Therapy Meetings of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Marrow Transplant Research).
The event is designed to highlight the latest research breakthroughs in hematopoietic cell transplantation (HCT), cellular therapy and gene therapy.
Imugene will present at 6:45pm Hawaii Standard Time on February 13, (3:45pm AEDT February 14) – the presentation can be viewed live on the company website.
The poster presentation is titled: Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior CD19-Directed CAR T-Cell Products.