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Clinical Trial
. 2025 Jan 6;31(1):65-73.
doi: 10.1158/1078-0432.CCR-24-1913.

A Phase II Study of Acimtamig (AFM13) in Patients with CD30-Positive, Relapsed, or Refractory Peripheral T-cell Lymphomas

Won Seog Kim  1 , Jake Shortt  2   3 , Pier Luigi Zinzani  4   5 , Natalia Mikhailova  6 , Dejan Radeski  7 , Vincent Ribrag  8 , Eva Domingo Domenech  9 , Ahmed Sawas  10 , Karenza Alexis  11 , Michael Emig  12 , Riham Elbadri  12 , Pallavi Hajela  12 , Paulien Ravenstijn  12 , Sheena Pinto  12 , Linta Garcia  11 , Andre Overesch  12 , Kerstin Pietzko  12 , Steven Horwitz  13
Affiliations
Clinical Trial

A Phase II Study of Acimtamig (AFM13) in Patients with CD30-Positive, Relapsed, or Refractory Peripheral T-cell Lymphomas

Won Seog Kim et al. Clin Cancer Res. .

Abstract

Purpose: Patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) generally have poor prognoses and limited treatment options. This study evaluated the efficacy of a novel CD30/CD16A bispecific innate cell engager, acimtamig (AFM13), in patients with R/R PTCL.

Patients and methods: Patients included those with CD30 expression in ≥1% of tumor cells and who were R/R following ≥1 prior line of systemic therapy. Acimtamig (200 mg) was administered once weekly in 8-week cycles. The primary endpoint was the overall response rate by fluorodeoxyglucose-PET per independent review committee; secondary and exploratory endpoints included duration of response, safety, progression-free survival, and overall survival.

Results: The overall response rate in 108 patients was 32.4% [95% confidence interval (CI), 23.7, 42.1] with a complete response rate of 10.2% (95% CI, 5.2, 17.5); the median duration of response was 2.3 months (95% CI, 1.9, 6.5). Patients with R/R angioimmunoblastic T-cell lymphoma exhibited the greatest number of responses [53.3% (95% CI, 34.3, 71.7)]. Responses were independent of CD30 expression level, prior brentuximab vedotin treatment, or steroid premedication. Acimtamig exhibited a tolerable safety profile; the most common treatment-related adverse events were infusion-related reactions in 27 patients (25.0%) and neutropenia in 11 patients (10.2%). No cases of cytokine release syndrome or acimtamig-related deaths were reported. Despite exhibiting promising clinical activity and tolerable safety in a heavily pretreated PTCL population, the study did not meet the criteria for the primary endpoint.

Conclusions: The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic NK cells.

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Conflict of interest statement

J. Shortt reports other support from Affimed during the conduct of the study; grants from Astex/Taiho, other support from Novartis and Bristol Myers Squibb, and personal fees from Otsuka, Mundipharma, Astellas, and Pfizer outside the submitted work; and a patent for WO2021243421 issued to Monash University and Peter MacCallum Cancer Centre. P.L. Zinzani reports other support from Novartis, Bristol Myers Squibb, Kyowa Kirin, Roche, BeiGene, Gilead, Janssen, AbbVie, Takeda, Incyte, and Sobi outside the submitted work. N. Mikhailova reports grants and nonfinancial support from Affimed GmbH during the conduct of the study, as well as grants and personal fees from Roche and personal fees from Janssen, AbbVie, Takeda, and Sanofi Genzyme outside the submitted work. D. Radeski reports other support from Affimed during the conduct of the study, as well as other support from Takeda and Kyowa Kirin outside the submitted work. V. Ribrag reports personal fees from AbbVie, AstraZeneca, BeiGene, Ipsen, and Eli Lilly and Company, grants from Astex and GSK, and other support from PEGASCY outside the submitted work, as well as employment with PEGASCY. E. Domingo Domenech reports personal fees from Takeda, Ideogen, and BeiGene outside the submitted work. K. Alexis reports personal fees from Affimed Inc. during the conduct of the study, as well as personal fees from Affimed Inc. outside the submitted work. M. Emig reports personal fees from Affimed GmbH during the conduct of the study, personal fees from Affimed GmbH outside the submitted work, and Affimed stock options. R. Elbadri reports personal fees from Affimed GmbH during the conduct of the study, personal fees from Affimed GmbH outside the submitted work, and Affimed stock options. P. Ravenstijn reports personal fees from Affirmed GmbH during the conduct of the study, as well as personal fees from Affimed GmbH outside the submitted work, and current employment with Astellas Pharma Europe BV. S. Pinto reports personal fees from Affirmed GmbH during the conduct of the study, as well as personal fees from Affimed GmbH outside the submitted work. A. Overesch reports personal fees from Affimed GmbH during the conduct of the study, personal fees from Affimed GmbH outside the submitted work, and Affimed stock options. K. Pietzko reports personal fees from Affimed during the conduct of the study; personal fees from Affimed GmbH outside the submitted work; and Affimed stock options. S. Horwitz reports grants from ADC Therapeutics, Affimed, Aileron, Celgene, CRISPR Therapeutics, Daiichi Sankyo, Forty Seven, Inc., Kyowa Hakko Kirin, Takeda, Secura Bio, Seattle Genetics, and Trillium Therapeutics during the conduct of the study, as well as personal fees from YingLi Pharma Limited, Takeda, Abcuro, Inc., Autolus, Auxilius Pharma, Corvus, Daiichi Sankyo, Dren Bio, J&J Medicine/Janssen Research & Development, Kyowa Hakko Kirin, March Bio, ONO Pharmaceuticals, Pfizer, Shoreline Biosciences, Inc., Secura Bio, and SymBio outside the submitted work. This research was supported in part through the NIH/NCI Cancer Center Support Grant P30 CA008748 (S. Horwitz). No disclosures were reported by the other authors.

Figures

Figure 1.
Figure 1.
Study design for the phase II trial of acimtamig in patients with CD30-positive, R/R PTCL. The study began with a 28-day prescreening phase starting from the time of informed consent, during which the tumor sample was tested for CD30 expression, and ALK expression in patients with sALCL. This was followed by a screening period lasting up to 21 days in which evaluations were carried out as per the protocol to assess eligibility to proceed to the treatment phase. Patients were initially recruited into two cohorts based on CD30 expression as indicated. Following a planned interim analysis, the cohorts were combined into a single cohort. Key endpoints for the study are shown. ALK, anaplastic lymphoma kinase.
Figure 2.
Figure 2.
Objective responses stratified by PTCL subtype, steroid premedication, prior BV, and tumor CD30 expression level. Top, ORR, CRR, and DoR in the overall cohort and stratified by PTCL subtype. Bottom, ORR, CRR, and DoR stratified by steroid premedication, prior BV, and tumor CD30 expression level. ALK, anaplastic lymphoma kinase; max, maximum; min, minimum; N, number; NE, not estimable; PTCL-NOS, PTCL-not otherwise specified.
Figure 3.
Figure 3.
Greatest percentage tumor change from baseline in sum of the products of diameters (SPD) based on CT per IRC assessment in individual patients. Each bar represents one patient. Only patients with a measurable postbaseline assessment are included. PTCL-NOS, PTCL-not otherwise specified.
Figure 4.
Figure 4.
Kaplan–Meier estimate of OS and PFS. PFS was assessed by FDG-PET per IRC. N, number; NE, not estimable.
See this image and copyright information in PMC

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