Roxadustat does not increase the risk for neoplasm, including kidney cancer, in patients with anemia of chronic kidney disease, according to new findings from the roxadustat global phase 3 clinical trials reported at the Kidney Week 2020 Reimagined virtual conference.
Hypoxia-inducible factors (HIF) are increased in many forms of cancer and are associated with poor outcomes. So there was some concern that roxadustat, an oral HIF prolyl hydroxylase inhibitor (HIF-PHI), might contribute to increased cancer risks.
In pooled data from the 3 nondialysis trials with mean roxadustat exposure of 84.6 weeks and the 3 dialysis trials with mean roxadustat exposure of 89.2 weeks, there were no clinically meaningful between-group differences in the incidence of neoplasm-related adverse events (AEs) or serious AEs, compared with placebo and epoetin, respectively, Daniel W. Coyne. MD, of Washington University in St. Louis, Missouri, reported.
In the nondialysis trials (OLYMPUS, ANDES, ALPS), 4270 patients were randomly assigned to roxadustat or placebo. Neoplasm-related AE rates were 2.5 per 100 person-exposure-years (PEY) in both the roxadustat and placebo groups. Neoplasm-related SAEs rates were 1.1 vs 1.3 per 100 PEY, respectively. In the dialysis trials (ROCKIES, SIERRAS, and HIMALAYAS), 3880 patients were randomly assigned to roxadustat or epoetin alfa. Neoplasm-related AE rates were 2.7 vs 2.3 per 100 PEY in the roxadustat and epoetin alfa groups, respectively. Neoplasm-related SAE rates were 1.1 vs 1.2 per 100 PEY, respectively.
In both the NDD- and DD-CKD trials, there were no clinically meaningful differences in the organ types of neoplasms, such as prostate or lung cancer or basal cell carcinoma, between groups.
Of interest, the incidence rate of renal cell carcinoma in the dialysis trials was 0.1 per 100 PEY for both the roxadustat and ESA group. There were no reported AEs of renal cell carcinoma in the nondialysis trials.
Disclosure: These clinical trials were supported by Fibrogen, AstraZeneca, and Astellas Pharma. Please see the original reference for a full list of authors’ disclosures.
Coyne DW, Fishbane S, Pergola PE, et al. Roxadustat is not associated with an increased risk of neoplasm in patients with CKD and anemia. Presented at: Kidney Week 2020 Reimagined, October 19-25, 2020. Poster TH-OR04.