Imugene Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL

Core Viewpoint - Imugene Limited has reported promising results from its Phase 1b clinical trial of azer-cel, an allogeneic CAR T-cell therapy for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), showing a 75% overall response rate and a 55% complete response rate [2][5][6]. Group 1: Clinical Trial Results - A total of six out of eleven evaluable patients achieved a Complete Response (CR), while three patients achieved a Partial Response (PR), leading to a best overall response rate of 75% [2][3]. - The duration of response is maturing, with the first patient remaining cancer-free at 15 months and others showing durable responses at 2, 5, and 11 months [6][7]. - The trial has expanded to include CAR T-naïve patients with other niche blood cancer indications, such as primary central nervous system lymphoma (PCNSL) [6][9]. Group 2: Regulatory and Development Plans - Imugene has received FDA Fast Track Designation for azer-cel in DLBCL, which facilitates the development and review process for drugs addressing serious conditions [5][8]. - The company plans to request a Type B (End of Phase 1) Meeting with the FDA in Q4 2025 to discuss data and designs for a pivotal trial [5][6]. Group 3: Market Context and Unmet Needs - DLBCL is the most common type of non-Hodgkin lymphoma, with approximately 160,000 global cases annually and a high unmet medical need, as around 60% of patients treated with existing therapies relapse [10]. - There are currently no CAR T-cell products approved for treating PCNSL, highlighting a significant opportunity for azer-cel in this area [10][11].