In patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL), the use of the tetravalent, bispecific antibody construct AFM13 was considered associated with clinical efficacy in an analysis of a phase 2 study. Study results were recently presented at the International Conference on Malignant Lymphoma 2023 by Won Seog Kim, MD, PhD, of Samsung Medical Center in Seoul, Korea, and colleagues.
The open-label, multicenter phase 2 REDIRECT study (ClinicalTrials.gov Identifier: NCT04101331) included patients with certain subtypes of R/R PTCL who had confirmed CD30+ expression in ≥1% of tumor cells and who had been treated with at least 1 prior systemic therapy. Patients in this study were given 200 mg of AFM13 once per week, through intravenous infusions, with treatment continued until disease progression, intolerable toxicity, withdrawal of consent, or investigator choice to terminate treatment.
The primary study endpoint was the overall response rate (ORR), based on fluorodeoxyglucose-positron emission tomography (FDG-PET) and assessed by an independent review committee. Several secondary endpoints were also evaluated.
Continue Reading
There were 108 patients in this study who received AFM13. The median patient age was 63 years (range, 21-93). Among PTCL subtypes represented in the patient population were PTCL not-otherwise specified (PTCL-NOS; n=41), angioimmunoblastic T-cell lymphoma (AITL; n=30), systemic anaplastic large cell lymphoma (sALCL; n=26), and other (n=11). The mean number of prior lines of therapy was 2.7.
The ORR for the overall population was 32.4%, and the complete response rate was 10.2%. By PTCL subtype, the ORRs were 22.0% for patients with PTCL-NOS, 53.3% for those with AITL, 23.1% for those with sALCL, and 36.4% with other as the subtype. Overall, the median duration of response was 2.3 months, the median progression-free survival duration was 3.5 months, and the median overall survival time was 13.8 months.
Treatment-emergent adverse events (TEAEs) that were considered related to AFM13 were present in 73.1% of the patients, with the most common being infusion-related reactions, neutropenia, and pyrexia. TEAEs considered related to AFM13 led to discontinuations in 2 patients, with these TEAEs being infusion-related reactions. There were no grade 5 TEAEs considered related to AFM13.
The study investigators concluded that AFM13 showed some efficacy in this study population, particularly in patients with AITL. They also indicated that further research is planned involving AFM13 in combination with allogeneic natural killer cells in patients with R/R CD30+ PTCL.
Disclosures: This research was supported by Affirmed GmbH. Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Reference
Kim WS, Shortt J, Zinzani PL, et al. AFM13 in patients with cd30 positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL): results from the phase 2 REDIRECT study. ICML 2023. June 13-17, 2023. Abstract 126.
