Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase (HDAC) inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Opdivo in a phase 3 trial of patients with advanced skin cancer.
The study, which included 404 melanoma patients across 15 countries, achieved its primary endpoint, as the combo produced a clinically meaningful improvement in progression-free survival.
Those who received HBI-8000 plus Opdivo remained alive and without their disease worsening for a median of 11.7 months, compared to a median of 7.4 months for those who were given Opdivo plus placebo. The 58% improvement was deemed statistically significant.
Huyabio, formally known as Huya Bioscience International, said that the study brings it a “step closer” to providing a potential “new frontline treatment option for one of the deadliest forms of skin cancer.” The company added that it is conducting further analysis to identify the efficacy advantage of HBI-8000.
“These results represent an exciting milestone for patients and the future of melanoma treatment,” Mireille Gillings, Ph.D., the CEO of Huyabio, said in a release. “Although immunotherapy has dramatically improved outcomes, many patients still need better options. We believe HBI-8000 will become an important addition to the standard of care, helping physicians improve outcomes while bringing new hope to patients and their families.”
Huyabio, which is based in San Diego and Shanghai, China, said that it will present full data at a future medical conference. The company did not spell out its regulatory plan for the combo.
As an HDAC inhibitor, HBI-8000 boosts the immune response against cancer cells through epigenetic modification. It reactivates tumor-suppressor genes, halts cell growth and makes tumors more visible to the immune system, increasing the efficiency of checkpoint inhibitors such as Opdivo.
HBI-8000 was approved as a monotherapy for the treatment of T-cell lymphoma in China (2014) and Japan (2021). It was also approved for breast cancer as combo therapy with an aromatase inhibitor in China (2019) and Taiwan (2023).