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

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

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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