Imugene's azer-cel shows promising early efficacy in lymphoma trial

Imugene Limited announced positive initial efficacy results from the CAR T-naïve portion of its Phase 1b trial for azer-cel, an allogeneic CD19 CAR T therapy. In six evaluable heavily pretreated CAR T-naïve patients, an 83% Overall Response Rate (ORR) was observed, with three patients achieving a 50% Complete Response (CR). The trial has treated ten patients to date across various CD19+ B-cell malignancies, including Diffuse Large B-cell Lymphoma (DLBCL) and rare subtypes like Waldenström macroglobulinemia (WM) and primary central nervous system lymphoma (PCNSL).

Enrolment in the CAR T-naïve expansion is proceeding significantly faster than the CAR T-relapsed DLBCL cohort, indicating strong clinical demand for an allogeneic approach. The company noted these initial results encompass areas of significant unmet clinical need where no CAR T products are currently approved. Imugene is also advancing its CAR T-naïve program to generate a broader evidence base and will discuss pivotal study design options for azer-cel in CAR T-relapsed DLBCL with the FDA in November.