Policy & Regulation
HUYABIO International treats first patient in trial of HBI-8000 combined with Bristol Myers Squibb's Opdivo
22 September 2021 -

HUYABIO International, a global developer of novel biopharmaceutical product opportunities originating in China, announced on Tuesday that it has treated its first patient in a pivotal trial aimed at measuring the safety and efficacy of HBI-8000 combined with Bristol Myers Squibb's anti-PD-1, antibody Opdivo (nivolumab), to treat patients with unresectable or metastatic melanoma.

The multicentre, randomised, double blinded, placebo-controlled Phase 3 trial is named 'Study Comparing the Investigational Drug HBI-8000 Combined with Opdivo vs. Opdivo in Patients with Advanced Melanoma'. It will have a primary outcome of objective response rate and progression-free survival, while secondary outcomes include safety and overall survival.

The trial is to enrol 480 patients from the United States, Europe, Australia, New Zealand and Japan. HBI-8000, an epigenetic immunomodulator, is approved in China to treat lymphoma and metastatic breast cancer.