Roxadustat Increases Hemoglobin In Patients With Chemotherapy-Induced Anemia

Roxadustat appears to be a well-tolerated, effective treatment for chemotherapy-induced anemia, according to a press release by FibroGen, Inc.

Roxadustat is an oral medication composed of HIF-PH inhibitors, which promote red blood cell production, also known as erythropoiesis. This is done through the increased endogenous production of erythropoietin, improved iron absorption, and mobilization, along with the downregulation of hepcidin. It is also being developed to treat anemia of chronic kidney disease and myelodysplastic syndrome-associated anemia.

Topline results of a single-arm WHITNEY trial (NCT04076943) found that roxadustat produced a maximum change in hemoglobin within 16 weeks from baseline without red blood cell transfusion, meeting the study’s primary end point.2 

The phase 2, open-label study had an actual enrollment of 92 participants and an actual completion date of April 2021. Secondary end points include mean change in hemoglobin level, change in hemoglobin, and the rate of red blood cell transfusion.

The study was composed of a single arm. All patients received roxadustat orally 3 times a week. The starting dose was 2.0mg/kg or 2.5mg/kg administered 3 times per week. The treatment period lasted for 16 weeks, with an additional 4-week follow-up period. Every 4 weeks, doses could be titrated.

In order to be included in the study, patients must have had a diagnosis of non-myeloid malignancy, anemia caused by cancer treatment, had planned concurrent treatment of cancer with chemotherapy for at least 8 additional weeks, and an estimated life expectancy of 6 months or more. All patients had a hemoglobin level at or below 10g/dL at the time of enrollment.

Patients who were receiving chemotherapy when the anticipated outcome was cure, only receiving hormonal products, have a history of leukemia, had received a red blood cell transfusion or erythropoietic therapy within 4 week of enrollment, any investigational drug within 8-weeks prior to treatment with roxadustat, anemia due to other etiologies, cardiovascular risk, a clinically significant or uncontrolled autoimmune disease, or known human immunodeficiency virus or hepatitis B or C infection were not eligible to participate. 

The agent was found to be well-tolerated, with no significant differences in treatment-emergent adverse events between different starting doses.

“Roxadustat is a promising new approach for treating chemotherapy-induced anemia, which complicates the treatment of many cancer patients,” said Mark D. Eisner, MD, MPH, chief medical officer of FibroGen, in a press release. “Further studies will be necessary to evaluate whether roxadustat can effectively and safely treat this important type of anemia.”

Final results will be presented at an upcoming medical conference.

_REFERENCES:

_{1.FibroGen announces positive topline results from phase 2 clinical trial of roxadustat for the treatment of chemotherapy induced anemia. News release. August 25, 2021. Accessed August 26, 2021. https://bit.ly/2WqYM7Q.} 

_{2.Evaluation of efficacy and safety of roxadustat for the treatment of chemotherapy induced anemia. ClinicalTrials.gov. Accessed August 26, 2021. https://bit.ly/3jkc0fH.}