한빛사논문
Won Seog Kim1, Jake Shortt2, Pier Luigi Zinzani3, Natalia Mikhailova4, Dejan Radeski5, Vincent Ribrag6, Eva Domingo Domenech7, Ahmed Sawas8, Karenza Alexis9, Michael Emig10, Riham Elbadri10, Pallavi Hajela10, Paulien Ravenstijn10, Sheena Pinto10, Linta Garcia9, Andre Overesch10, Kerstin Pietzko10, Steven Horwitz11
1Department of Hematology-Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea
2Department of Medicine, School of Clinical Sciences, Faculty of Medicine, Nursing & Health Sciences, Monash University, Clayton, Victoria, Australia and Department of Medicine and Monash Hematology, Health, Melbourne, Clayton, Victoria, Australia
3IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia “Seràgnoli”, Bologna, Italy; Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy
4Raisa Gorbacheva Memorial Institute of Children Oncology Hematology and Transplantation, First Saint Petersburg State Pavlov Medical University, Saint Petersburg, Russian Federation
5Linear Clinical Research & Sir Charles Gairdner Hospital, Perth, Western Australia
6Institut Gustave Roussy, Villejuif, France
7Institut Catala d’Oncologia, Hospital Duran i Reynals, IDIBELL, Barcelona, Spain
8Columbia University Medical Center, New York, USA
9Affimed Inc, New York, USA
10Affimed GmbH, Mannheim, Germany
11Memorial Sloan Kettering Cancer Center, New York, USA
Corresponding author: Dr Won Seog Kim
Abstract
Background: Patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) generally have poor prognoses and limited treatment options.
Materials & Methods: This study evaluated the efficacy of a novel CD30/CD16A bispecific innate cell engager, acimtamig (AFM13), in patients with R/R PTCL. 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 overall response rate (ORR) by fluorodeoxyglucose-positron emission tomography per independent review committee; secondary and exploratory endpoints included duration of response (DoR), safety, progression-free survival, and overall survival.
Results: The ORR in 108 patients was 32.4% (95% CI: 23.7, 42.1) with a complete response rate of 10.2% (95% CI: 5.2, 17.5); median DoR 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 natural killer cells.
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