On November 30, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported the regulatory approval of HBI-8000, brand name Hiyasta, monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596262]).
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"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.
The application of the supplemental indication for R/R PTCL is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Hiyasta, in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Hiyasta that will benefit even more patients."
About Hiyasta
HBI-8000 is an epigenetic immunomodulator with several approved indications including monotherapy for two subtypes of Non-Hodgkin’s Lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor nivolumab.