Study confirms tolerability and significant anti-tumor activity of HBI-8000 in combination with nivolumab in checkpoint naive melanoma patients
San Diego, CA, USA – 9 November 2020 – HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the presentation of results from an ongoing Phase II study evaluating the efficacy and safety of HBI-8000 in combination with nivolumab in patients with advanced metastatic melanoma. The results were presented at the Society for Immunotherapy of Cancer’s virtual 35th Anniversary Annual Meeting (SITC 2020; Abstract # 797).
“Data from this combination study are very encouraging,” said lead investigator, Nikhil I. Khushalani, MD, Vice Chair and Senior Member of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, Florida. “As standard of care, patients with metastatic melanoma are routinely treated with a PD-1 inhibitor such as nivolumab or pembrolizumab.
When nivolumab was combined with HBI-8000, it appears the efficacy was enhanced while safety profile remains quite acceptable. The patients on the study are being followed for long- term outcomes. A Phase III study to further investigate the efficacy and safety of this combination of therapy is now planned.”
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “These data further demonstrate the promise of HBI-8000 in cancer therapy. This builds on the momentum from our October 2020 regulatory submission to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL).”
In a Phase Ib/II trial in patients with melanoma, renal and non-small cell lung cancer, the recommended Phase II dose of HBI-8000 was 30 mg orally twice weekly combined with nivolumab administered at the approved dosing schedule. The SITC 2020 presentation described the safety profile of this combination in melanoma patients and showed signs of clinical benefit relative to historic controls who were receiving nivolumab for the first time.
Forty-nine patients (32 anti-PD1 naïve, 17 with prior anti-PD1 therapy) were treated with HBI- 8000 in combination with nivolumab. The median age was 63 years (range 28-84). The most common all grade treatment related adverse events (AEs) were fatigue (n=25), diarrhea (n=24), abdominal pain (n=14), and lymphopenia (n=13). Although HBI-8000 related thrombocytopenia (n=25) and neutropenia (n=15) were common, clinically significant bleeding or febrile neutropenia were not seen. Twelve patients discontinued treatment due to AEs. Among 31 anti- PD1 naïve patients evaluable for response, there were 23 objective responses (74%), five with stable disease (disease control rate 90%), and three with progressive disease. Median time to response was 1.9 months. At a median follow-up for this cohort of 8.9 months (range, 0.9-35.5 months), the median duration of response and median progression-free survival had not yet been reached.
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also is immunomodulatory, increasing the efficacy of checkpoint inhibitors in preclinical animal models through its role in sustaining acetylation and nuclear transport of PD-L1.
About HUYA Bioscience 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 global 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, South Korea, Canada, Ireland and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com.
Bob Goodenow, PhD
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