Roxadustat Demonstrates Noninferiority in Chemotherapy-Induced Anemia

Detailed findings from the trial assessing roxadustat will be presented at a future medical conference.

Roxadustat (Evrenzo) was non-inferior to recombinant erythropoietin α in the treatment of chemotherapy-induced anemia among patients receiving concurrent chemotherapy for non-myeloid malignancies, according to a press release on positive topline findings from a phase 3 trial (NCT05301517) in China.

Investigators reported that roxadustat met the study’s primary end point of noninferiority. Developer FibroGen also announced its intention to file a supplemental new drug application in China for this therapy.

Roxadustat treatment achieved a non-inferior change in hemoglobin level, as measured from baseline to the average level over weeks 9 to 13 compared with recombinant erythropoietin α. The toxicity profile of roxadustat was favorable and consistent prior data.

Detailed findings from the trial will be presented at a future medical conference.

“Roxadustat is a promising potential new oral drug for treating chemotherapy-induced anemia, which complicates the treatment of many patients [with cancer],” Mark D. Eisner, MD, MPH, chief medical officer of FibroGen, said in the press release. “Chemotherapy-induced anemia remains an unmet medical need in China, and we believe that roxadustat has potential to improve the lives of these patients.”

Roxadustat, delivered orally, is the first of a class of hypoxia-inducible factor prolyl hydroxylase inhibitors which increase endogenous production of erythropoietin, improve iron absorption and mobilization, and downregulate hepcidin to bolster the production of red blood cells.

Investigators of this randomized, open-label trial enrolled 159 patients with any non-myeloid malignancy who had a baseline hemoglobin level of 10 g/dL or lower. Patients received either roxadustat or erythropoietin α 3 times per week over a period of 12 weeks. There was an additional 4-week follow-up period after the conclusion of treatment.

The primary end point of the trial was change in hemoglobin level as measured from baseline to average over weeks 9 to 13. Secondary end points included the proportion of patients who experienced an increase in hemoglobin of 10 g/L or greater from baseline through week 13, the proportion who required a red blood cell transfusion, the proportion who experienced hemoglobin levels lower than 60 g/L between week 5 and week 13, and the change in Functional Assessment of Cancer Therapy-Anemia subscale scores from baseline to the average over weeks 9 to 13.

The percentage of patients who required dose reductions or dose holds of chemotherapy due to anemia was another secondary end point.

Patients were required to have had a histologically or cytologically confirmed non-myeloid malignancy to be eligible for inclusion on the trial. They also needed to experience chemotherapy-related anemia, defined as a hemoglobin level of no greater than 100 g/L at screening and a documented decrease in this level of at least 10 g/L after the initiation of chemotherapy. Patients were also required to have an ECOG performance status of 1 or 2 to be included.

The trial excluded patients receiving curative intent myelosuppressive chemotherapy. Patients were also excluded if they were only receiving hormonal agents, biological agents, novel immunosuppressive agents, or targeted biological or radiation therapy as a treatment for cancer unless they were also co-administered chemotherapy. Other exclusion criteria included receipt of a red blood cell transfusion or erythropoiesis stimulating agents within 4 weeks of randomization, as well as any clinically significant anemia caused by other etiologies.

Reference

FibroGen announces positive topline results from China pivotal phase 3 clinical trial of roxadustat for the treatment of chemotherapy induced anemia. News Release. FibroGen, Inc. May 18, 2023. Accessed May 22, 2023. https://yhoo.it/3OwObkU