Imugene reports promising Azer-cel results for advanced lymphoma patients in Phase 1b trial

Imugene (ASX: IMU) has announced positive results from a Phase 1b clinical trial using lead candidate azer-cel on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Ten enrolled patients had previously undergone up to five lines of cancer treatment for the non-Hodgkin’s lymphoma, including autologous chimeric antigen receptor (CAR) T-cell therapy—all of which had been unsuccessful in removing tumours.

Azer-cel is a first-in-class allogeneic (or “off-the-shelf”) CD19 CAR T-cell therapy made from donor-derived T-cells that have been modified using proprietary gene editing technology.

Cohort dosage

Six patients in Cohort A of the trial received a dosage of chemotherapy and azer-cel, while four patients in Cohort B received chemotherapy and azer-cel plus interleukin-2 (IL-2)—a cytokine that blocks the reproduction and spread of cancer cells.

One patient in Cohort A registered a complete response – meaning all tumours had disappeared under treatment – and another experienced a partial response, defined as a reduction in tumours as confirmed by scan.

The durability of responses in this group was reported to be less than 60 days.

Complete response

Three patients in Cohort B have been treated to date, with two returning a complete response and one being reported with stable disease, whereby scans show a decrease in tumour size.

However, potential T-cell infiltration shows an increase in signal intensity, possibly representing an increase in the size of a primary tumour or the appearance of a new lesion followed by tumour regression.

Imugene said the patient remains in the study and will continue to be assessed for response at follow-up scans.

The first two patients in Cohort B also maintained a complete response for over 120 and 90 days, respectively.

‘Encouraging results’

Imugene chief executive officer Leslie Chong said the results were encouraging for DLBCL patients.

“I am proud of our clinical development team who assessed ways to enhance azer-cel’s durability of response, as one of the biggest challenges in CAR T-cell therapy is ensuring that the modified T-cells stay in the body long enough to kill cancer cells,” she said.

“To maximise the response rates and durability further, we added a very low dose of IL-2 to the regimen in Cohort B and early results suggest improved outcomes in patients.”

“We will continue to seek biomarker evidence from this group to see if our strategy improves the performance of azer-cel.”

Trial sites

Patients in the Phase 1b clinical trial are being recruited across 15 leading cancer research sites in the US including Columbia University, University of Minnesota, Emory University and Moffitt Cancer Centres.

Ms Chong said Imugene is also planning to open up to five trial sites in Australia.