HBI-8000 Plus Nivolumab Is Safe, Active in Melanoma
Source: Targeted Oncology, December 2024
The combination of HBI-8000 and nivolumab induced a response in nearly two-thirds of patients with advanced melanoma and no prior anti–PD-1/PD-L1 treatment.
Combining the novel agent HBI-8000 with nivolumab (Opdivo) showed promising efficacy and tolerability in patients with melanoma and no prior anti–PD-1/PD-L1 treatment, according to findings from a phase 2 trial presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting.
A total of 39 eligible patients were enrolled in the study and treated with HBI-8000 at 30 mg twice weekly (BIW) plus nivolumab in phases 1b and 2 (n = 37), or HBI-8000 at 40 mg BIW plus nivolumab in phase 1b (n = 2). The overall response rate for the 38 patients evaluable for efficacy was 65.8%. This included 6 (15.8%) complete responses and 19 (50%) partial responses. The clinical benefit rate was 87%. Further, with a median follow-up of 37 months, the median progression-free survival was 36.9 months (95% CI, 6.7 to not evaluable), and the median duration of response was not reached at the time of this analysis.