On September 29, 2026 HUYABIO International, the leader in accelerating the development of innovative biopharmaceutical products discovered in China, reported that further data from its pivotal phase 3 trial of HBI-8000 in combination with nivolumab in advanced melanoma has been selected as a Late-Breaking Abstract (LBA) and will be presented in an oral Proffered Paper session at ESMO (Free ESMO Whitepaper) Congress 2026 taking place Oct. 23 – 27 in Madrid, Spain.
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HBI-8000 is a highly differentiated oral selective Class I histone deacetylase (HDAC) inhibitor designed to boost the immune response against cancer cells through epigenetic modification. By modifying the tumor microenvironment from non-responsive (‘cold’) to responsive (‘hot’), HBI-8000 has the potential to enhance the activity of anti-PD-1 checkpoint inhibitors such as nivolumab.
HUYABIO announced topline results from the global Phase 3 trial in July which showed a statistically significant improvement in median progression-free survival (mPFS) in advanced melanoma patients taking HBI-8000 and nivolumab compared with those taking nivolumab plus placebo. The randomized global Phase 3 trial enrolled 404 patients across 15 countries.
The abstract will be available on the ESMO (Free ESMO Whitepaper) website at 00:05 CET on Friday, October 23.
Details of the ESMO (Free ESMO Whitepaper) Congress 2026 presentation
Abstract Number: LBA54 – Primary Analysis of HBI-8000-303: A Randomized Phase 3 Trial of Nivolumab plus HBI-8000 or Placebo in Advanced Melanoma
Presenter: Nikhil I. Khushalani, Moffitt Cancer Center, Tampa, FL, USA
Proffered Paper Session Details: Friday, October 23 at 16:15 – 17:45 CET in Barcelona Auditorium – Hall 9
(Press release, HUYA Bioscience, SEP 29, 2026, View Source [SID1234671161])