HUYABIO International announced the presentation of final data from a Phase 2 study evaluating HBI-8000 in combination with nivolumab for the treatment of advanced and metastatic melanoma. The results, presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting by Dr. Nikhil Khushalani from Moffitt Cancer Center, highlight the potential of this novel combination to improve patient outcomes.
HBI-8000, an oral drug, combined with nivolumab, an anti-PD1 therapy, has demonstrated encouraging efficacy signals in treating patients with advanced and metastatic melanoma. This combination offers clinically meaningful advantages over traditional double immune checkpoint inhibitor combinations by providing patients with an oral treatment option alongside nivolumab, potentially enhancing efficacy and reducing toxicities.
Key Findings from the Phase 2 Trial
The Phase 1b/2 trial evaluated the combination of HBI-8000 with nivolumab in advanced melanoma, kidney cancer, and non-small cell lung cancer. In the melanoma cohort, patients with metastatic melanoma who had not previously been treated with an anti-PD(L)-1 inhibitor were enrolled. The recommended Phase 2 dose of HBI-8000 was 30mg orally twice weekly (BIW) combined with intravenous nivolumab administered at the manufacturer’s approved dosing schedule. Disease status was assessed every 8 weeks using RECIST v1.1 criteria, and treatment continued until disease progression, unacceptable toxicity, or completion of 24 months of therapy.
Dr. Nikhil Khushalani stated, "The combination appears safe and effective in this Phase 2 study, which may show great promise in this patient population. HBI-8000 plus nivolumab could be an important addition to the armamentarium of oncologists treating this disease and is currently being investigated in a Phase 3 study."
Addressing Unmet Needs in Melanoma Treatment
The combination of HBI-8000 and nivolumab represents a significant advancement in melanoma treatment. As the first combination therapy that does not rely on dual immune checkpoint inhibitors, it presents a desirable option for community practices and specialty cancer centers, particularly in regions with limited technical support. This therapy can potentially expand combination therapy for melanoma containing nivolumab-backbone beyond established markets in the U.S. and EU, providing access to more patients worldwide.
Dr. Mireille Gillings, President, CEO & Executive Chair at HUYABIO, noted, "The promising results from the HBI-8000 and nivolumab combination represent a significant advancement in treating advanced melanoma. Coupling oral convenience with a reduction in immune-related toxicities will give clinicians new tools to improve patient outcomes."
