Chipscreen Biosciences is pleased to note that its international partner, HUYABIO International, has reported positive topline results from a global, randomized, double-blind, active-comparator-controlled Phase III clinical trial evaluating chidamide (Epidaza^®) in combination with nivolumab as a first-line treatment for advanced melanoma. The trial achieved statistically significant and clinically meaningful results, offering a potential new first-line treatment option for patients with melanoma, the deadliest form of skin cancer, and renewed hope for patients and their families.

The global, multicenter Phase III trial enrolled 404 patients across 15 countries and met its primary endpoint. Patients treated with chidamide in combination with nivolumab achieved a median progression-free survival (mPFS) of 11.7 months, compared with 7.4 months for patients receiving placebo in combination with nivolumab, demonstrating a statistically significant and clinically meaningful improvement. HUYABIO is conducting additional statistical analyses to further characterize the significant efficacy advantages of the chidamide-based combination regimen.

“These results represent an exciting milestone for patients and the future of melanoma treatment,” said Dr. Mireille Gillings, CEO and Executive Chairman of HUYABIO. “While immunotherapy has significantly improved treatment outcomes, many patients still need more effective treatment options. We believe chidamide has the potential to become an important addition to standard-of-care therapies, helping physicians improve patient outcomes while offering new hope to patients and their families.” Detailed results from the HBI-8000-303 clinical trial evaluating chidamide in combination with nivolumab will be presented at future medical conferences.