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Leuk Lymphoma. 2019 Mar;60(3):675-684. doi: 10.1080/10428194.2018.1492122. Epub 2018 Aug 30.

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

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a Department of Lymphoid Malignancies , Maria Skłodowska-Curie Institute - Oncology Center , Warszawa , Poland.
b Clinical Hospital Coltea , Bucharest , Romania.
c Department for Hematology and Transplantology , University Clinical Centre, Medical University of Gdansk , Gdansk , Poland.
d Department of Internal Medicine, Hematology and Oncology , University Hospital Brno , Brno , Czech Republic.
e 4SC AG , Martinsried, Planegg , Germany.


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.


Hodgkin lymphoma; Resminostat; epigenetics; histone deacetylase

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