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HDAC inhibitor plus nivolumab cuts melanoma progression risk by 27% in Phase 3 trial

HDAC inhibitor plus nivolumab cuts melanoma progression risk by 27% in Phase 3 trial

New Capabilities

Oral HBI-8000 with nivolumab extends progression-free survival to 11.7 months in advanced melanoma

Yesterday: Full results presented at ESMO Congress 2026

Overview

Updated 1 hour ago

A twice-weekly pill that strips melanoma cells of their camouflage extended progression-free survival by more than four months when added to the standard immunotherapy nivolumab. The Phase 3 result, presented at the European Society for Medical Oncology (ESMO) congress in Madrid, cut the risk of disease progression or death by 27%.

The combination matters because it offers a frontline option that doesn't rely on dual immune checkpoint inhibitors, which carry overlapping toxicity risks. HBI-8000, made by San Diego-based HUYABIO International, is an oral histone deacetylase (HDAC) inhibitor that makes 'cold' tumors visible to the immune system, enhancing the activity of anti-PD-1 drugs like nivolumab.

Why it matters

If approved, this oral-plus-infusion combo could give advanced melanoma patients a frontline option with fewer immune side effects than dual checkpoint therapy.

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Key Indicators

27%
Reduction in risk of disease progression or death
Hazard ratio 0.73 for HBI-8000 plus nivolumab vs nivolumab alone (p=0.014)
11.7 months
Median progression-free survival with combination
vs 7.4 months for nivolumab plus placebo
404
Patients enrolled in Phase 3 trial
Across 15 countries in the HBI-8000-303 study
41.4%
Objective response rate with combination
vs 32.3% for nivolumab alone

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People Involved

NK
Nikhil Khushalani
Lead investigator; Vice-Chair, Department of Cutaneous Oncology, H Lee Moffitt Cancer Center
Presented the Phase 3 results at ESMO Congress 2026
PA
Paolo Ascierto
Professor, University of Naples Federico II; President, Melanoma Foundation
Key author of the Phase 3 study

Organizations Involved

HUYABIO International
HUYABIO International
Biopharmaceutical company
Developer of HBI-8000; plans to share Phase 3 data with the FDA

San Diego-based biotech developing HBI-8000, an oral HDAC inhibitor already approved for lymphoma in China and Japan.
Bristol Myers Squibb
Bristol Myers Squibb
Pharmaceutical company
Collaborator on the trial; manufacturer of nivolumab (Opdivo)

Makes nivolumab, the anti-PD-1 checkpoint inhibitor used in the combination.

Timeline

August 2021 October 2026

3 events Latest: Yesterday

  1. Full results presented at ESMO Congress 2026

    Latest Conference Presentation

    Lead investigator Nikhil Khushalani presents data showing 27% risk reduction and median PFS of 11.7 vs 7.4 months.

  2. Topline results released

    Clinical Trial

    HUYABIO announces the trial met its primary endpoint, showing improved progression-free survival for the combination.

  3. Phase 3 trial HBI-8000-303 begins

    Clinical Trial

    Enrollment starts for 404 patients across 15 countries testing HBI-8000 plus nivolumab vs placebo plus nivolumab.

Scenarios

1

FDA approves HBI-8000 plus nivolumab for advanced melanoma

Possible Resolves by Q2 2028

Discussed by: HUYABIO says it will share the data with the FDA; no filing has been announced yet

HUYABIO plans to present the Phase 3 data to the US Food and Drug Administration. If the agency accepts a filing and the data hold up under review, the combination could become a new frontline option for advanced melanoma. Regulatory review typically takes months to a year or more after submission.

2

HUYABIO signs a global commercialization partnership

Likely Resolves by End of 2027

Discussed by: Company statement that it intends to engage with potential commercial partners

HUYABIO says it will seek commercial partners to bring the treatment to patients globally. A partnership would give the company resources to complete remaining trials and commercialize the drug outside China and Japan, where HBI-8000 is already approved for lymphoma.

3

Overall survival data confirm or weaken the benefit

Uncertain Resolves by End of 2028

Discussed by: Trial investigators; OS data remain immature with follow-up ongoing

The trial's overall survival data are not yet mature. If the final analysis shows a statistically significant survival benefit, it would strengthen the case for approval. If the benefit fades, regulators may ask for more data before clearing the combination.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

September 2015

Ipilimumab plus nivolumab approval (2015)

The FDA approved the combination of two checkpoint inhibitors, ipilimumab and nivolumab, for advanced melanoma. It was the first dual checkpoint regimen and became a standard of care, but it carries high rates of immune-related side effects.

Then

The combo improved survival, but roughly half of patients experienced serious immune-related adverse events.

Now

Dual checkpoint inhibition remains a standard for melanoma, but its toxicity has driven the search for alternatives.

Why this matters now

The HBI-8000 plus nivolumab combination aims to offer a frontline option that avoids the overlapping toxicities of dual checkpoint inhibition.

October 2006

Vorinostat approval (2006)

The FDA approved vorinostat, the first histone deacetylase (HDAC) inhibitor, for cutaneous T-cell lymphoma. Romidepsin followed in 2009.

Then

HDAC inhibitors became a treatment option for blood cancers.

Now

For two decades, HDAC inhibitors showed limited benefit in solid tumors. This trial is the first to show one improving anti-PD-1 therapy in melanoma.

Why this matters now

HBI-8000 is a newer, selective Class I HDAC inhibitor. The melanoma result is the first time this drug class has improved checkpoint inhibitor outcomes in a solid tumor.

September-December 2014

PD-1 inhibitor approvals (2014)

The FDA approved pembrolizumab and nivolumab for advanced melanoma, transforming treatment. These anti-PD-1 drugs became the backbone of melanoma immunotherapy.

Then

Response rates and survival improved dramatically compared with older chemotherapy.

Now

Anti-PD-1 monotherapy became standard, but many patients still don't respond, driving research into combinations.

Why this matters now

The HBI-8000 trial builds on nivolumab by adding an epigenetic modifier designed to turn non-responsive 'cold' tumors into responsive 'hot' ones.

Sources

(8)
+2
PR Newswire BioSpace HUYABIO International ClinicalTrials.gov Targeted Oncology Fierce Pharma University of Naples Federico II BioSpectrum Asia