The bispecific antibody AFM13 elicits responses in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), according to results of a phase 2 study presented at the AACR Annual Meeting 2023.
The highest overall and complete response rates were seen in patients with angioimmunoblastic T-cell lymphoma (AITL), said study presenter Won Seog Kim, MD, of the Sungkyunkwan University School of Medicine in Seoul, South Korea.
Dr Kim explained that AFM13 is a tretravalent, bispecific antibody targeting CD30 and CD16A, which promotes natural killer cell-mediated activity against CD30-positive PTCL tumor cells.
Dr Kim and colleagues evaluated AFM13 in a phase 2 trial of 108 patients with CD30-expressing relapsed/refractory PTCL (ClinicalTrials.gov Identifier: NCT04101331). The patients’ median age at baseline was 63 (range, 21-93) years, and 61.1% of patients were men.
Thirty-eight percent of patients had PTCL not otherwise specified (NOS), 27.8% had AITL, 24.1% had systemic anaplastic large-cell lymphoma (sALCL), and 11.1% had other PTCL subtypes. Patients had received a mean of 2.7 prior lines of therapy, including brentuximab vedotin (46.3%) and autologous transplant (38.9%).
At the beginning of the study, patients were assigned to 2 cohorts based on CD30 expression level (≥10% vs <10%). These cohorts were combined after the interim analysis showed them to be comparable.
Patients received AFM13 at 200 mg weekly until disease progression, unacceptable toxicity, consent withdrawal, or termination by an investigator.
The overall response rate was 32.4% for the entire cohort, 53.3% for AITL patients, 23.1% for sALCL patients, 22% for PTCL-NOS patients, and 36.4% for patients with other PTCL subtypes.
The complete response rate was 10.2% overall, 26.7% for AITL patients, 3.8% for sALCL patients, 2.4% for PTCL-NOS patients, and 9.1% for patients with other PTCL subtypes.
Dr Kim noted that there were no meaningful differences in response when patients were stratified by CD30 expression level.
The median duration of response was 2.3 months, and the median duration of complete response was 3.6 months. The median progression-free survival was 3.5 months, and the median overall survival was 13.8 months.
Treatment-related adverse events (TRAEs) occurred in 73.1% of patients, and grade 3 or higher TRAEs occurred in 30.6%. The most common grade 3 or higher TRAEs were neutropenia (7.4%), infusion-related reactions (5.6%), and anemia (3.7%). There were no fatal TRAEs.
Dr Kim concluded that AFM13 had manageable toxicity and “robust” efficacy in this cohort of patients with relapsed/refractory PTCL.
Disclosures: This research was supported by Affimed GmbH. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Kim WS, Shortt J, Zinzani PL, et al. REDIRECT: A phase 2 study of AFM13 in patients with CD30‑positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL). AACR 2023. April 14-19, 2023. Abstract CT024.