Adding investigational therapy chidamide to Aromasin (exemestane) significantly delayed disease progression or death in patients with advanced breast cancer, results from a Phase 3 trial show.
This means that the pivotal trial (NCT02482753) has met its primary goal of progression-free survival, while maintaining a manageable safety profile, Chipscreen Biosciences recently announced.
This is the first trial demonstrating the beneficial effects of Aromasin and chidamide in hormone receptor (HR)-positive advanced breast cancer patients who had failed prior hormone therapy.
Chidamide, developed by China-based Chipscreen, is an inhibitor of histone deacetylase (HDAC) enzymes with a better tolerability profile than other HDAC inhibitors.
The medicine prevents the growth, proliferation, and transformation of cancer cells, and induces anti-cancer immune responses. It is being evaluated in multiple clinical trials, either alone or in combination with other therapies, as a potential treatment for several blood and solid cancers.
This randomized, double-blind, placebo-controlled Phase 3 trial was designed to evaluate the safety and effectiveness of chidamide in combination with Aromasin in postmenopausal women with advanced breast cancer.
It included 328 women with HER-2 negative, HR-positive cancers who had failed prior lines of treatment with tamoxifen or a nonsteroidal aromatase inhibitor. They were randomly divided in two groups: those who received daily dose of oral Aromasin along with chidamide twice a week and those who received Aromasin alone.
Results of the open-label pilot study that preceded the Phase 3 trial were presented at the 2017 American Society of Clinical Oncology meeting, and included data from 20 patients, treated for a median of five 28-day cycles.
During the study, three patients discontinued therapy due to adverse events. The most common severe adverse effects were low levels of neutrophils, platelets, or leukocytes.
Among the 18 patients assessed for effectiveness, three experienced a partial reduction in their tumors, and 12 had their disease stabilized. The median time a patient lived without signs of disease worsening was 7.6 months.
In December 2014, chidamide was approved by the China Food and Drug Administration for the treatment of recurrent and refractory peripheral T-cell lymphoma in China, where it is sold under the brand name Epidaza.