Imugene Limited (ASX:IMU) Announces Positive Phase 1b Trial Results for Azer-cel
Trial Results
Imugene Limited (ASX: IMU) reported an overall response rate of 75% in its Phase 1b trial of azer-cel for relapsed diffuse large B-cell lymphoma (DLBCL). The therapy has achieved a total of six complete responses and three partial responses among 12 evaluable patients, with durability data maturing.
Future Plans
Based on the positive outcomes, Imugene expects to meet with the US FDA in Q4 2025 to discuss a pivotal study for azer-cel. The trial is now open to enrolling CAR T naïve patients with other lymphoma subtypes.
Executive Comments
Leslie Chong, Managing Director and CEO of Imugene, said: “We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA.
Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel.”
Dr John Byon, Chief Medical Officer of Imugene, said: “DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment.
We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists.”
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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