Abstract
HBI-8000 is a small molecule inhibitor of class I HDACs and has been approved for the treatment of PTCL, ATL and, in combination with exemestane, in a subpopulation of breast cancer. Given the roles of HDACs in normal and cancerous cells, there are currently multiple clinical trials, by HUYABIO International, to test the efficacy of HBI-8000 in monotherapy or in combination settings in leukemias and in solid tumors. The current review is focused on the applications of HDACi HBI-8000 in cancer therapy and its potential in combination with DDR agents.
Highlights
histone deacetylases (HDACs) and their role in physiological or disease status have been extensively studied (1)
HBI-8000 was well tolerated with expected toxicities that could be managed with supportive care and dose modifications
Most adverse events (AEs) were grade 1 or 2, and grade ≥ 3 that occurred in ≥10% patients were thrombocytopenia (22%), leucopenia (13%) and neutropenia (11%), respectively (10)
Summary
HDACs and their role in physiological or disease status have been extensively studied (1). Inhibition of HDACs by HBI-8000 affects the expression of multiple downstream genes involved in cancer cell survival and proliferation, thereby suppressing tumor growth and invasiveness (3). HBI-8000 showed reasonable safety and tolerability in the IND enabling studies, and was approved in 2014 by the China National Medical Products Administration for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL) (5). HBI-8000 was approved in 2019 in combination with aromatase inhibitors for the treatment of breast cancer (locally advanced or metastatic) (6). HUYABIO International LLC (HUYABIO, San Diego, CA, USA) successfully licensed the rights to develop and commercialize HBI-8000 globally outside of China. HUYABIO initiated HBI-8000 clinical trials in relapsed/refractory adult T cell lymphoma/leukemia (R/R ATL) in Japan as monotherapy and later in combination with nivolumab in solid tumors in the USA.
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