Imugene prepares pivotal azer-cel trial with FDA - ICYMI

Core Insights - Imugene Ltd's cell therapy candidate azer-cel has demonstrated strong response rates in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), achieving an 81% response rate in those who failed autologous CAR-T therapy and an 83% response rate in a newly opened cohort of CAR-T naïve patients [1][4][7] Regulatory and Scientific Milestones - The company is preparing for a meeting with the US FDA in November to discuss the design and regulatory pathway for a planned Phase 2/3 trial, with a detailed briefing document already submitted [2][5] - The data from azer-cel supports potential registration strategies not only in DLBCL but also in other blood cancers such as marginal zone and primary CNS lymphoma [2][4] Presentation and Clinical Confidence - azer-cel will be featured in an oral presentation at the 67th American Society of Hematology Annual Meeting in December, which is significant as oral presentations are peer-reviewed and reserved for highly significant data [3][6][7] - Enrollment in the CAR-T naïve cohort has increased fourfold, indicating growing confidence from clinicians in the azer-cel program [3][7]