Health · Pharma & Biotech · 1 hr ago
HBI-8000 combination improves results in advanced melanoma trial
A pill called HBI-8000 showed promise against advanced melanoma when added to the immunotherapy drug nivolumab.
Melanoma is a cancer, and nivolumab works by helping the immune system attack cancer cells.
HBI-8000 is intended to make cancer cells easier for the immune system to recognize by blocking enzymes that help them hide.
The international phase 3 trial involved 404 people with advanced melanoma who had not previously received immunotherapy, and its results were presented at a cancer conference in Madrid.
The combination lowered the risk of disease progression by 27% compared with nivolumab alone.
Median time without progression was 11.7 months with the combination and 7.4 months with nivolumab alone; tumours shrank in 41.4% of patients, versus 32.3% in the comparison group.
The combination had a manageable safety profile with mild side effects, but no next step for the treatment was stated.
Adding HBI-8000 to nivolumab reduced the risk of disease progression by 27% in a phase 3 trial of advanced melanoma.
Median progression-free survival was 11.7 months with the combination, compared with 7.4 months with nivolumab alone.
Tumor regression occurred in 41.4% of patients receiving the combination, compared with 32.3% in the control group.
The international HBI-8000-303 trial included 404 patients with advanced melanoma who had not previously received immunotherapy.
Results were presented at the European Society for Medical Oncology congress in Madrid.
- Who
- The trial involved 404 patients with advanced melanoma. Paolo Ascierto was among its principal authors.
- What
- A phase 3 trial found that adding HBI-8000 to nivolumab improved results compared with nivolumab alone.
- When
- Results were presented at the European Society for Medical Oncology congress; the article was published on October 23, 2026.
- Where
- The results were presented at the congress in Madrid.
- Why
- The study tested whether HBI-8000 could enhance immunotherapy by making tumor cells more visible to the immune system.
This story does not have two clearly opposing sides.
The international phase 3 HBI-8000-303 trial studied 404 patients with advanced melanoma who had not previously received immunotherapy.
The trial's main results were presented in Madrid.
- Trial
- HBI-8000-303, phase 3
- Participants
- 404 patients with advanced melanoma
- Combination median progression-free survival
- 11.7 months
- Nivolumab-alone median progression-free survival
- 7.4 months
- Tumor regression
- 41.4% with the combination; 32.3% in the control group
- Progression risk
- 27% lower with the combination
What people are saying
With this combination we enter a new dimension of immunotherapy, in which we far surpass the tumor's ability to hide.
Having an additional pill option that enhances immunotherapy without burdening tolerability represents a further step forward, also benefiting patients' quality of life.