Recent positive Phase 2 data showing HBI-8000 plus Opdivo achieved ~70% ORR and >90% disease control in checkpoint naïve advanced melanoma patients, with encouraging PFS of about 36.9 months vs 5.7 months on nivolumab monotherapy.
Pivotal global Phase 3 trial (HBI-8000‑303) is ongoing, comparing HBI‑8000 + nivolumab vs nivolumab plus placebo in 480 unresectable/metastatic melanoma patients, with primary endpoints ORR and PFS.
The combination is generally well tolerated, positioning Huyabio’s Opdivo combo as a potential new first‑line option for advanced skin cancer.
Sources:
HUYABIO Announces First Patient Treated in a Pivotal ...
プレスリリース - HUYABIO International
HUYABIO InternationalはBristol Myers Squibbと悪性黒色腫の国際共同試験を発表 - HUYABIO International
HBI-8000 + Nivolumab for Melanoma · Info for Participants
Nivolumab-Based Treatments for Advanced Melanoma - NCI
HUYABIO Presents Positive Phase 2 Data on HBI-8000 ...
Immune Checkpoint Therapy Combination Approved for Advanced ...
Huyabio International and BMS to collaborate on melanoma clinical
U.S. Food and Drug Administration Approves Opdivo ...
Bristol Myers Squibb Announces Opdivo® (nivolumab) in ...
FDA approves nivolumab for adjuvant treatment of Stage IIB/C ...