2026-04-13T04:58:56Zhttps://recercat.cat/oai/request

oai:recercat.cat:2445/2195812025-11-20T15:05:18Zcom_2072_1057col_2072_478916col_2072_478917

urn:hdl:2445/219581 A Phase 2 study of acimtamig (AFM13) in patients with CD30-positive, relapsed or refractory peripheral T-cell lymphomas Kim, Won Seog Shortt, Jake Zinzani, Pier Luigi Mikhailova, Natalia Radeski, Dejan Ribrag, Vincent Domingo Domènech, Eva Sawas, Ahmed Alexis, Karenza Emig, Michael Elbadri, Riham Hajela, Pallavi Ravenstijn, Paulien Pinto, Sheena Garcia, Linta Overesch, Andre Pietzko, Kerstin Horwitz, Steven Limfomes Assaigs clínics Lymphomas Clinical trials 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. 2025-03-10T10:50:26Z 2025-03-10T10:50:26Z 2024-11-12 2025-02-05T13:18:46Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.1158/1078-0432.CCR-24-1913 Clinical Cancer Research, 2025, vol. 31, num. 1, p. 65-73 https://doi.org/10.1158/1078-0432.CCR-24-1913 cc-by-nc-nd (c) Kim, Won Seog et al., 2024 http://creativecommons.org/licenses/by-nc-nd/3.0/es/ info:eu-repo/semantics/openAccess American Association for Cancer Research (AACR) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))