Incyte Biosciences Shanghai Co., Ltd.

This study will consist of 2 parts: Part 1 aims to confirm the safety and PK of axalitimab in Chinese cGVHD subjects, and Part 2 is mainly to evaluate the efficacy of axalitimab in Chinese cGVHD subjects. After 10 subjects are enrolled in Part 1 and complete at least 1 cycle of axatilimab 0.3 mg/kg Q2W treatment, data analysis will be performed and safety assessment will be performed by SMC. All subjects in Part 1 will continue to complete Axatilimab treatment as planned as long as the treatment discontinuation criteria are not met. If no additional safety signals are observed, Part 2 of the study will be initiated. Part 2 will continue to enroll 20 cGVHD subjects.

INCB 57643-103 is a Phase I, open-label, global, multicenter study evaluating the safety and tolerability of INCB057643 in subjects with myelofibrosis and other advanced myeloid neoplasms. Only patients with myelofibrosis were enrolled in China. The patients were divided into two sub-cohorts: monotherapy and combination therapy with ruxolitinib.