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

  • Clin Cancer Res. 2025 Jan 6;31(1):65-73. doi: 10.1158/1078-0432.CCR-24-1913.
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
  • 1. Department of Hematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 2. Department of Medicine, School of Clinical Sciences, Faculty of Medicine, Nursing & Health Sciences, Monash University, Clayton, Victoria, Australia.
  • 3. Monash Hematology, Monash Health, Clayton, Victoria, Australia.
  • 4. IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli," Bologna, Italy.
  • 5. Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
  • 6. Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, First Saint Petersburg State Pavlov Medical University, Saint Petersburg, Russia.
  • 7. Linear Clinical Research & Sir Charles Gairdner Hospital, Perth, Western Australia.
  • 8. Institut Gustave Roussy, Villejuif, France.
  • 9. Institut Catala d'Oncologia, Hospital Duran i Reynals, IDIBELL, Barcelona, Spain.
  • 10. Columbia University Medical Center, New York, New York.
  • 11. Affimed Inc., New York, New York.
  • 12. Affimed GmbH, Mannheim, Germany.
  • 13. Memorial Sloan Kettering Cancer Center, New York, New York.
PMID: 39531538 DOI: 10.1158/1078-0432.CCR-24-1913
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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