AFM13 in patients with relapsed or refractory classical Hodgkin lymphoma: final results of an open-label, randomized, multicenter phase II trial.

Christina Grosse-Thie, Andreas Engert, Peter Borchmann, Michael Fuchs, Bastian von Tresckow, Markus Dietlein, Carsten Kobe, Maike de Wit, Sven Thorspecken, Stephanie Sasse, Martin Bentz, Sonja Martin, Christian Koenecke, Nadezda Basara, Andreas Hüttmann, Annette Plütschow, Jesko Momotow, Paul Jan Bröckelmann

Journal: Leukemia & lymphoma 2022;63(8):1871-1878

PMID: 35848865

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Abstract

In patients with relapse of classical Hodgkin lymphoma (cHL) after autologous stem cell transplant, brentuximab vedotin and anti-PD1 treatment, the outcome is poor. To assess the efficacy of the bispecific anti-CD30/CD16A, NK-cell engaging antibody AFM13 and to select the optimal treatment schedule (arm A-C), we initiated a randomized two-stage phase II trial (NCT02321592). Due to slow recruitment, the trial was terminated after treatment of 25 patients. Treatment with AFM13 was well tolerated: only two treatment-associated serious adverse events (SAEs) were reported; all SAEs resolved completely. With an objective response rate (ORR) of 16.7% (1/5 in arm A, 1/11 in arm B, and 2/8 in arm C) and a 12-month progression-free survival (PFS) of 12.6% (95% CI 3.2-28.9), treatment efficacy of AFM13 monotherapy in all evaluable patients was modest. The continuous application schedule (arm C) might be more effective, but the visit schedule should be better aligned with patients' daily life.

Address: German Hodgkin Study Group (GHSG), Cologne, Germany.; Clinic for Hematology, Oncology and Gastroenterology, Maria Hilf Hospital Moenchengladbach, Moenchengladbach, Germany.; Department I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), University of Cologne, Cologne, Germany.; Department of Hematology and Stem Cell Transplantation, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.; St. Franziskus Hospital Flensburg, Flensburg, Germany.; Department of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.; Department of Hematology, Oncology, Palliative Medicine, Robert-Bosch-Hospital, Stuttgart, Germany.; Municipal Hospital Karlsruhe, Karlsruhe, Germany.; Department of Internal Medicine, Medical Clinic III - Hematology, Oncology, Palliative Medicine, Rostock University Medical Center, Rostock, Germany.; Hematology, Oncology, Immunology, Hospital Schwabing, München, Germany.; Department of Medicine - Hematology, Oncology, Palliative Medicine, Vivantes Hospital Neukölln, Berlin, Germany.; Department of Nuclear Medicine, University Hospital of Cologne, Cologne, Germany.

DOI: 10.1080/10428194.2022.2095623

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MeSH Terms: Antibodies, Monoclonal, Antineoplastic Agents, Brentuximab Vedotin, Hodgkin Disease, Humans, Immunoconjugates, Ki-1 Antigen, Neoplasm Recurrence, Local