Abexinostat, an oral pan-histone deacetylase inhibitor (HDACi), had significant clinical activity and was well tolerated overall in patients with relapsed/refractory follicular lymphoma, a study published in the journal Clinical Cancer Research has shown.1
Because additional targeted agents are needed for the treatment of lymphoma, and HDACi have demonstrated efficacy in cutaneous T-cell lymphoma, researchers sought to evaluate abexinostat in relapsed/refractory lymphoma.
For the phase 1 portion, researchers enrolled 25 heavily pretreated patients with any lymphoma subtype. All participants received abexinostat 30 to 60 mg/m2 orally twice daily 5 days per week for 3 weeks or 7 days per week every other week. The maximum tolerated dose was determined to be 45 mg/m2 twice daily 7 days per week administered every other week.
For the phase 2 study, researchers enrolled 30 patients with relapsed/refractory follicular lymphoma or mantle cell lymphoma. All received the recommended dose identified in phase 1.
Results showed that overall response rate was 64.3% among the 25 evaluable patients. Researchers found that median progression-free survival was 20.5 months and median duration of response had not yet been reached.
For patients specifically with follicular lymphoma, 89% received treatment for more than 8 months.
Those with mantle cell lymphoma had an overall response rate of 27.3% and a median progression-free survival of 3.9 months.
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In terms of safety, the most common grade 3 to 4 treatment-related adverse events were thrombocytopenia, fatigue, and neutropenia. Of note, researchers observed an occurrence of QTc prolongation, but it was rare.
- Evens AM, Balasubramanian S, Vose JM, et al. A phase I/II multicenter, open-label study of the oral histone deacetylase inhibitor abexinostat in relapsed/refractory lymphoma. Clin Cancer Res. 2016;22:1059.