AZD0486 Demonstrates Early Efficacy for R/R DLBCL With Manageable Safety Profile
Tae Min Kim, MD, Seoul National University Hospital, Seoul, South Korea, discusses the results from a phase 1 trial evaluating the safety and efficacy of AZD0486, a novel CD19-CD3 bispecific T-cell engager, for the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who previously received at least 2 lines of therapy.
These data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
The results of this analysis demonstrated efficacy and safety for AZD0486 for patients who have R/R DLBCL.
Transcript:
Hello, my name is Tae Min Kim from Seoul National University Hospital of South Korea. I am the presenter for this work, AZD0486 for refractory and relapsed B-cell malignancy, including diffuse large B-cell lymphoma in the poster session.
Regarding diffuse large B-cell lymphoma and [patients] who failed to prior second-line treatment, there's no approved option. Currently there are 3 CD28 T-cell engagers approved. However, in this agent it is a CD19 and CD3 bispecific engager. [It] reduced cytokine release syndrome, however, it maintained the efficacy, we call that a decoupling strategy in this compound.
Regarding DLBCL and the third-line setting, this compound has very promising activity against DLBCL and achieving the response rate of 75% in the 25-milligram cohort. Regarding the CAR-T-naive patient, the CR rate is 67%, regarding CAR-T exposed patients, their complete response rate was 50%.
Regarding the safety profiles, this agent resulted in a low rate of CRS observed, below 50%. Exactly 44% had a CRS event, mostly grade 1 or 2. Regarding neurotoxicity, ICANS event, was observed at 20%. However mostly grade 1 or 2, and the higher grade ICANS events especially in high tumor burden DLBCL patients.
We did not determine the final maximum tolerated dose (MTD) for DLBCL patients and currently we are evaluating the MTD and hope to expand of this treatment in the relapse/refractory setting in DLBCL in the near future.
Source:
Kim TM, Yoon DH, Gaballa SR, et al. Safety and efficacy of AZD0486, a CD19xCD3 T-cell engager, in relapsed or refractory diffuse large B-cell lymphoma. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract 7046.
