VIDEO: Roxadustat not linked to increased neoplasm risk in CKD, anemia
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Jay B. Wish, MD, clinical medicine professor at Indiana University School of Medicine, reported that roxadustat was not linked to increased risk for neoplasm in patients with nondialysis- and dialysis-dependent chronic kidney disease.
Pooled data from six phase 3 studies – presented at ASN Kidney Week – showed no clinically meaningful differences in the exposure-adjusted incidence rate of neoplasm-related treatment-emergent adverse events and treatment-emergent serious adverse events between roxadustat-treated patients and comparator-treated patients. For dialysis patients, the comparator was epoetin alfa and for the non-dialysis patients, it was primarily placebo.
Wish, who is also co-chair of the Nephrology News & Issues Editorial Advisory Board, said these results were “somewhat comforting” because it showed no increase in tumor progression or incidence of tumors among patients treated with a HIF stabilizer. He explained there has been some “residual concern” since the TREAT study found patients treated with high-dose darbepoetin had a higher risk for death from preexisting neoplasms.
“This is the study that originally raised the concern that treatment of anemia in the setting of non-dialysis CKD could potentially be tumorgenic or tumor accelerating. With the mechanism of action with HIF stabilizers having to do with the cellular and tissue response hypoxia, that concern is magnified,” Wish said.
These data on roxadustat should clear some of “the hesitation that some clinicians may have in adopting these new agents once they’re approved by the FDA,” Wish said.
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Coyne D, et al. #TH-OR04. Presented at: ASN Kidney Week. Oct. 22-25 (virtual meeting).
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