HUYA Bioscience International Presents Positive Data On HBI-8000 at Society for Immunotherapy of Cancer Meeting
SAN DIEGO, Nov. 9, 2020 /PRNewswire/ -- 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.
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