Latest Clinical Study of Anfulike Selected for European Hematology Association Congress

Organized by the European Hematology Association (EHA), the 28th EHA Congress was held in Frankfurt, Germany, on June 8-11, 2023. EHA Congress is one of the world's largest international conferences in the field of hematology, covering studies on hematology in all aspects. A summary from a clinical study of CSPC Anfulike^® (Amphotericin B cholesterol sulfate Complex, ABCD) was selected for the meeting. Detailed information is as: 

Study Title 

Efficacy and safety of ABCD in the treatment of invasive aspergillosis in patients with hematologic diseases 

Abstract No.

PB2589

Presentation Form

Publication

Principal Investigator 

Feng Sizhou, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College 

Summary of Study 

The patient data in this study were collected as of September 2022, with a total of 22 patients included for an interim analysis. All enrolled patients were evaluated for safety, and 16 (72.7%) who received treatment for at least 1 week were evaluated for efficacy. The median age was 42.5 years (18-68 years), and the underlying disease was mainly acute myeloid leukemia (n=19, 86.4%). Most patients presented characteristic pulmonary aspergillus infection (n=21, 95.5%); aspergillus was detected in 2 patients (9.1%). 

In this study, 81.8% (n=18) of patients were treated with ABCD after the failure of antifungal therapy (n= 6, 27.3%) or prevention breakthrough (n=12, 54.5%). The median duration of treatment with ABCD was 16 (1-28) days, and the average daily dose was (2.3±0.7) mg·kg·d. The overall response rate was 81.3% (13/16). Only 9.1% (n=2) of patients experienced early discontinuation due to infusion reactions. Grade 3/4 adverse events included fever (4.5%), hypokalemia (31.8%), and elevated ALT (9.1%), and there were no grade 3/4 elevated creatinine. 

In patients currently receiving treatment, ABCD (Anfulike^®) shows good clinical efficacy and safety in the treatment of invasive aspergillus disease and excellent kidney safety, providing a new option for antifungal therapy.