HBI-8000 Plus Nivolumab Significantly Improves Progression-Free Survival in Advanced Melanoma

Clinical Summary: 

• Design/Population: This global, randomized phase 3 trial evaluated HBI-8000 plus nivolumab versus nivolumab plus placebo as first-line treatment in 404 patients with advanced melanoma enrolled across 15 countries.
• Key Outcomes: The study met its primary end point, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival with HBI-8000 plus nivolumab. Median progression-free survival was 11.7 months with the combination versus 7.4 months with nivolumab plus placebo.
• Clinical Relevance: These findings support HBI-8000 plus nivolumab as a potential new first-line treatment option for advanced melanoma and provide the basis for future regulatory submissions and presentation of detailed efficacy and safety data.

Topline results from a global phase 3 trial demonstrated that HBI-8000, an oral histone deacetylase (HDAC) inhibitor, plus nivolumab significantly improved progression-free survival (PFS) compared with nivolumab plus placebo in patients with advanced melanoma.

In this randomized, placebo-controlled phase 3 trial, 404 patients with advanced melanoma enrolled across 15 countries were assigned to receive first-line HBI-8000 plus nivolumab or nivolumab plus placebo. The primary end point was PFS.

The trial met its primary end point, with patients receiving HBI-8000 plus nivolumab achieving a median PFS of 11.7 months compared with 7.4 months for those receiving nivolumab plus placebo, representing a statistically significant and clinically meaningful improvement.

“These results represent an exciting milestone for patients and the future of melanoma treatment,” said Mireille Gillings, PhD, chief executive officer and executive chair of HUYABIO International. “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.”

Additional efficacy and safety analyses are ongoing. Detailed results will be presented at a future scientific meeting and are expected to support regulatory submissions.

Source: 

PR Newswire. HUYABIO international delivers significant landmark phase 3 results in advanced melanoma. Accessed on July 16, 2026. https://prnmedia.prnewswire.com/news-releases/huyabio-international-delivers-significant-landmark-phase-3-results-in-advanced-melanoma-302823857.html