Roxadustat Proves Noninferior to Erythropoietin Alfa in Non-Myeloid Malignancies
A phase 3 trial evaluating roxadustat for the treatment of anemia in patients receiving concurrent chemotherapy for non-myeloid malignancies met its primary end point.
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Treatment with roxadustat (FG-4592) demonstrated noninferiority vs recombinant erythropoietin alfa (Sepo) regarding the primary end point of change in hemoglobin level from baseline to an average level during weeks 9 to 13 for the treatment of anemia in Chinese patients receiving concurrent chemotherapy for non-myeloid malignancies, according to an ongoing phase 3 trial (NCT05301517).1
These data come from the preliminary safety analysis of the trial and showed that in addition to the primary end point of the study being met, the adverse event (AE) profile of roxadustat was consistent with previously reported findings. When utilized in this patient population, roxadustat proved to have a favorable benefit/risk profile.
Further detailed results from the trial will be submitted for presentation at an upcoming meeting, and the company plans to work with AstraZeneca and the China Health Authority to file a supplemental new drug application for roxadustat for the treatment of anemia in patients receiving concurrent chemotherapy for non-myeloid malignancies.
“Roxadustat is a promising potential new oral drug for treating chemotherapy-induced anemia, which complicates the treatment of many [patients with] cancer. Chemotherapy-induced anemia remains an unmet medical need in China, and we believe that roxadustat has potential to improve the lives of these patients,” said Mark D. Eisner, MD, MPH, chief medical officer of FibroGen, Inc., in a press release.
In the randomized, open-label, active-controlled, phase 3 trial, patients aged 18 years and older with a histologically or cytologically confirmed non-myeloid malignancy and anemia related to myelosuppressive chemotherapy were enrolled and given treatment with roxadustat to evaluate its efficacy. Patients enrolled were required to weigh at least 40 kg, have an ECOG performance status of 1 or 2, ferritin of at least 50 ng/mL, and transferrin saturation of at least 10%.2
A total of 159 patients were randomly assigned to receive either oral roxadustat or erythropoietin alfa 3 times a week for 12 weeks to achieve Hb levels of 100-120 g/L. The follow-up period was an additional 4 weeks. With roxadustat, the starting dose was based on the participant's weight, and the maximum dose for each participant could not exceed 3.5 mg/kg or 400 mg 3 times a week, whichever was lower. The starting dose for erythropoietin alfa was 150 international units/kg subcutaneously 3 times a week.
The primary end point investigated in the trial was change in Hb level from baseline to average level during weeks 9 through 13. Secondary end points consisted of the percentage of patients who achieve an increase in Hb from baseline to week 13 of at least 10 g/L, percentage of patients who need red blood cell (RBC) transfusion, change in Functional Assessment of Cancer Therapy – Anemia Subscale Score from baseline over weeks 9 to 13, and average change in Functional Assessment of Chronic Illness Therapy – Fatigue Subscale score from baseline over weeks 9 to 13, percentage of patients who required a dose reduction or a dose-hold of chemotherapy due to anemia, and more.
Roxadustat is a HIF prolyl-hydroxylase inhibitor, which promotes erythropoiesis by boosting endogenous production of erythropoietin. Roxadustat also enhances iron absorption and mobilization, as well as dowregulation of hepcidin.1 In addition to multiple other studies being conducted in China and Japan, the agent is also being investigated in the United States for the treatment of chemotherapy induced anemia (NCT04076943).
REFERENCES:
1. 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 19, 2023. https://yhoo.it/3OpQlmd
2. A study to evaluate the efficacy and safety of roxadustat for the treatment of anemia in participants receiving chemotherapy treatment for non-myeloid malignancies. ClinicalTrials.gov. Updated May 1, 2023. Accessed May 19, 2023. https://clinicaltrials.gov/ct2/show/NCT05301517
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