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Resminostat in patients with relapsed or refractory Hodgkin lymphoma: results of the phase II SAPHIRE study

J. Walewski, E. Paszkiewicz-Kozik, G. Borsaru, A. Hellmann, A. Janikova, A. Warszewska, A. Mais, A. Ammendola, T. Herz, B. Krauss, SW. Henning,

. 2019 ; 60 (3) : 675-684. [pub] 20180830

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze II, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc20022876

This open-label, single-arm phase II study examined efficacy, safety, pharmacokinetics, and biomarkers of histone deacetylase (HDAC) inhibitor resminostat in patients with relapsed or refractory Hodgkin lymphoma. Thirty-seven heavily pretreated patients received 600 (19 patients) or 800 mg (18 patients) oral resminostat daily for the initial 5 days of 14-day treatment cycles. Objective response rate (ORR) (primary) was 34% reaching disease control in 54% patients. Most patients (69%) showed reduced tumor size and reduced [18F]-FDG uptake in target lesions (71%). Median progression-free survival (PFS) was 2.3 months (95%CI [1.3; 3.3]) and median overall survival (OS) was 12.5 months (95%CI [9.6; 18.6]). Patients who responded or stabilized under resminostat had a 10-month longer OS than patients who progressed. Efficacy assessment, pharmacodynamics, and exploratory biomarker results followed plasma levels, showed target engagement and epigenetic modulations. Common drug-related adverse events (AEs) were nausea, vomiting, anemia, thrombocytopenia, and fatigue, mainly grade 1 or 2.

Citace poskytuje Crossref.org

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