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Soo Park, MD
Soo Park, MD
Posted: Wednesday, November 20, 2024
Treatment with the class I histone deacetylase inhibitor (HDAC) HBI-8000 plus the PD-1 inhibitor nivolumab appeared to be safe and active in patients with PD-1/PD-L1 inhibitor–naive advanced melanoma. Nikhil I. Khushalani, MD, of H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, and colleagues presented the final analysis of the phase Ib/II HBI-8000–302 trial at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 620).
“Based on these encouraging results, a global phase III trial evaluating HBI-8000 combined with nivolumab vs nivolumab alone as first-line treatment of unresectable or metastatic melanoma is currently ongoing,” the investigators remarked.
A total of 39 patients with metastatic disease were treated with HBI-8000 (30 mg twice weekly [recommended phase II dose] in phases Ib and II: n = 37; 40 mg twice weekly in phase Ib: n = 2) plus nivolumab. In the efficacy-evaluable population (n = 38), the overall response rate was 65.8%. A total of 15.8% (n = 6) and 50.0% (n = 19) of patients achieved complete and partial responses, respectively. The clinical benefit rate was 87%. With a median follow-up of 37 months, the median progression-free survival was 36.9 months. The median duration of response was not reached.
Colitis, fatigue, decreased appetite, pancreatitis, diarrhea, abdominal pain, and weight loss were found to be among the most common treatment-related adverse events of grade 3 or higher. The most frequently reported treatment-related laboratory adverse events of grade 3 or higher included hypophosphatemia, neutropenia (no febrile neutropenia), lymphopenia, anemia, increased alanine aminotransferase levels, and thrombocytopenia. A total of 17 patients discontinued treatment because of adverse events.
Disclosure: No information regarding conflicts of interest was provided.
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