Xgeva: Additional Ph III 20090482 data

Additional data from the double-blind, international Phase III 20090482 trial in 1,718 patients with newly diagnosed MM showed that 120 mg subcutaneous Xgeva every 4 weeks led to a median time to first on-study SRE, the primary endpoint, of 22.83 months vs. 23.98 months for IV zoledronic acid (HR=0.98, 95% CI: 0.85, 1.14, p=0.01 for non-inferiority). Xgeva was not superior to zoledronic acid on the primary endpoint (p=0.82). Xgeva missed the secondary endpoint of improving OS vs. zoledronic acid (HR=0.9, 95% CI: 0.7, 1.16, p=0.41). Additionally, Xgeva improved median progression-free survival (PFS) by 10.7 months compared to zoledronic acid (HR=0.82, 95% CI: 0.68, 0.99, p=0.036). Data were presented at the International Myeloma Workshop in New Delhi. Amgen previously reported that Xgeva met the primary endpoint of non-inferiority to IV zoledronic acid in delaying the time to first on-study SRE vs. zoledronic acid (HR=0.98, 95% CI: 0.85, 1.14, p=0.01) (see BioCentury, Dec. 1, 2016)...