HUYABIO International Announces Pivotal Data for HBI-8000 in Advanced Melanoma Selected for Late-Breaking Presentation at ESMO Congress 2026

Presentation in oral Proffered Paper session follows positive topline Phase 3 data showing a statistically significant improvement in median progression-free survival in advanced melanoma patients when HBI-8000 was combined with nivolumab vs immunotherapy alone

SAN DIEGO, Sept. 29, 2026 /PRNewswire/ -- HUYABIO International, the leader in accelerating the development of innovative biopharmaceutical products discovered in China, announced today 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 Congress 2026 taking place Oct. 23 - 27 in Madrid, Spain.

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 website at 00:05 CET on Friday, October 23.

Details of the ESMO 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

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, Europe, and China, the company has become a partner of choice to accelerate product development and maximize patient impact and value globally.

For more information, visit www.huyabio.com.

About HBI-8000

HBI-8000 (tucidinostat/chidamide) is potentially the best-in-class immuno-modulator. It is a highly differentiated oral, Class I-selective histone deacetylase (HDAC) inhibitor with an immunomodulatory mechanism. Through epigenetic modification, HBI-8000 has anti-tumor activity and converts an immunologically "cold" tumor microenvironment "hot", thereby increasing responsiveness to checkpoint inhibitors. HBI-8000 is approved and has been prescribed to over 112,000 patients as monotherapy for the treatment of T-cell lymphoma in China (as Epidaza ®) and Japan (as HIYASTA®), and in combination with an aromatase inhibitor for breast cancer in China and Taiwan, and in combination with R-CHOP in diffuse large B-cell lymphoma in China.

About the Phase 3 HBI-8000-303 trial

HBI-8000-303 [NCT04674683] is a global multicenter, randomized, double-blind, placebo-controlled Phase 3 study comparing the efficacy and safety of HBI-8000 combined with nivolumab to placebo combined with nivolumab in patients with unresectable or metastatic melanoma. The trial has completed enrollment and topline results were released in July 2026.

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SOURCE HUYABIO International