Hematide peginesatide: Phase III data

Top-line data from the open-label, U.S. Phase III PEARL 1 trial in 490 non-dialysis patients showed that 0.025 and 0.04 mg/kg Hematide every 4 weeks met the primary endpoint of non-inferiority to 0.75 µg/kg Aranesp darbepoetin alfa every 2 weeks in mean Hb change from baseline to between weeks 25-36 (1.39 and 1.64 g/dL, respectively, vs. 1.37 g/dL). However, a pooled analysis of 983 non-dialysis patients in the Phase III PEARL 1 and PEARL 2 trials showed that the proportion of patients experiencing >=1 cardiovascular event was significantly higher for Hematide vs. Aranesp (21.6% vs. 17.1%; HR=1.34, 90% CI: 1.03, 1.73). The partners said the result was primarily driven by higher rates of death, unstable angina and arrhythmia in Hematide-treated patients.

On secondary endpoints, the proportion of patients who received red blood cell transfusions was not significantly different between low- and high-dose Hematide vs. Aranesp (6.2% and 7.3% vs. 4.9%), while the proportion of patients whose mean Hb was within the target range of 11-12 g/dL was similar between treatment arms (93% and 93% vs. 94%). ...