Abexinostat Active in R/R Follicular Lymphoma

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.

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.

Reference

1. 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.