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OLYMPUS trial shows advantages of roxadustat vs placebo for increasing hemoglobin
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WASHINGTON — Results from the phase 3 OLYMPUS trial presented here show the investigational hypoxia-inducible factor prolyl hydroxylase inhibitor drug roxadustat significantly increased hemoglobin levels in patients with anemia and chronic kidney disease compared to those treated with placebo.
“Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing hemoglobin levels and managing anemia, which is often underdiagnosed and undertreated,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in a company press release. In the companion ROCKIES trial, roxadustat demonstrated a mean increase of 0.77g/dL averaged during weeks 28 to 52 compared to 0.68 g/dL with epoetin alfa.
In the OLYMPUS trial, roxadustat, given in 70 mg doses orally three times a week, demonstrated a statistically significant improvement in hemoglobin levels from baseline, with a mean increase of 1.75 g/dL averaged during weeks 28 to 52 compared to 0.40 g/dL with placebo, the primary efficacy endpoint. Patients in both groups — 1,384 patients in the roxadustat group and 1,377 patients in the placebo group — had baseline hemoglobin levels of less than 10 g/dL
Also, 42% of patients in the roxadustat group and 43% in the placebo group had GFRs of less than 15 mL/min/1.73 m2.
Patients in the OLYMPUS trial were in CKD stages 3, 4 and 5. OLYMPUS evaluated 2,781 patients with anemia (Hb <10 g/dL) in CKD stages 3 to 5 who were randomized 1:1 to roxadustat or placebo across 26 countries.
“When we look at it over time, we can see that the increase in the hemoglobin was achieved relatively early” in the roxadustat group, Steven Fishbane, MD, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, and a primary investigator on the OLYMPUS trial, said.
One of the challenges, he noted, was that 38% of patients in the placebo group started on dialysis during the trial.
“You aren’t allowed to rescue these patients” and treat their anemia, Fishbane said, which skewed the hemoglobin response in that group.
Roxadustat did improve hemoglobin levels from baseline in a subgroup of patients with elevated high-sensitivity C-reactive protein (hsCRP) levels of greater than 5 mg/L, with a statistically significant mean increase of 1.73g/dL, compared to 0.62g/dL with placebo.
Data from the phase 3 OLYMPUS and ROCKIES trials, together with the efficacy and pooled CV safety data from the global phase 3 program, will form part of the FDA regulatory submission in the United States, anticipated in the fourth quarter of 2019.
The global phase 3 program consisted of seven trials in more than 9,000 patients and was conducted by AstraZeneca, FibroGen and Astellas. – by Mark E. Neumann
References:
Fishbane S, et al. TH-ORO23. Presented at: ASN Kidney Week; Nov. 7-10, 2019; Washington, D.C.
Disclosure: Fishbane reports grants from Cara Therapeutics Inc.