• 100% Overall Response Rate (ORR) in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)
• 80% ORR in Marginal Zone Lymphoma (MZL)
• Enrolment in the CAR T-naive cohort progressing faster than in the earlier CAR T-relapsed DLBCL cohort

Imugene Limited, a clinical-stage immuno-oncology company, has provided an update on the CAR T-naive cohort of its ongoing Phase 1b basket study of azer-cel, an off-the-shelf, allogeneic CAR T cell therapy. The study is evaluating azer-cel across multiple advanced B-cell malignancies with significant unmet medical need. In the encouraging early signals, a 100% Overall Response Rate (ORR) was observed in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) (4/4 Partial Responses, PR) in patients who had received a median of ≥3 prior lines of therapy. An 80% ORR was observed in Marginal Zone Lymphoma (MZL) (3/5 Complete Responses, CR; 1/5 PR) in patients who had received a median of ≥2 prior lines of therapy. Enrolment in the CAR T-naive expansion cohort is progressing faster than in the earlier CAR T-relapsed DLBCL cohort, reflecting strong clinical demand and investigator support for an allogeneic approach. The company has also amended the Phase 1b protocol to evaluate azer-cel in combination with a BTK inhibitor and to include patients with mantle cell lymphoma (MCL). This combination arm will enrol patients who have previously failed BTK inhibitor therapy to evaluate safety and preliminary efficacy, including response rates, in the relevant patient populations.

No high-importance, price-sensitive forward-looking financial metrics provided.

The company believes the addition of the BTK inhibitor combination arm represents a meaningful opportunity to expand the clinical scope of the azer-cel program, particularly for advanced patients who have failed prior BTK inhibitor therapy. The company intends to prioritise those indications demonstrating the strongest clinical activity, while certain other indications may not be pursued further.