Positive results from new analyses of denosumab Phase 3 trials
February 27, 2016
In the 244 trial of patients with advanced solid tumors (excluding breast and prostate) or multiple myeloma, denosumab-treated patients also experienced a delay in clinically significant worsening of pain compared with patients on Zometa (median 169 days: denosumab, 143 days: Zometa; hazard ratio 0.85, 95 percent CI: 0.73, 0.98).
Exploratory Analysis Shows Denosumab Superior to Zometa in Delaying Time to First SRE or Hypercalcemia of Malignancy (Abstract 9042)
A pre-specified exploratory analysis of the 244 trial found that patients receiving denosumab also experienced a significantly longer time to first SRE or hypercalcemia of malignancy, a severe and sudden increase of calcium in the bones that has a very poor prognosis (19.0 months denosumab versus 14.4 months Zometa, hazard ratio 0.83, 95 percent CI: 0.71, 0.97; Best of ASCO" for 2010).
Adverse Events in Study 136
Overall, the incidence of AEs (96 percent denosumab, 97 percent Zometa) and serious AEs (44 percent denosumab, 46 percent Zometa) was consistent with what has previously been reported for these two agents. AEs potentially associated with renal toxicity occurred in 4.9 percent of patients treated with denosumab compared to 8.5 percent in patients treated with Zometa. ONJ was seen infrequently in both treatment groups (20 patients receiving denosumab (2.0 percent) as compared with 14 patients (1.4 percent) receiving Zometa). There was no statistically significant difference in the rate of ONJ between the two treatment arms. Infectious AEs were balanced between the two treatment arms. Overall survival (hazard ratio 0.95, 95 percent CI: 0.81, 1.11).
Adverse Events in Study 244
AEs rates (96 percent denosumab, 96 percent Zometa) and serious AEs (63 percent denosumab, 66 percent Zometa) were similar between groups and were consistent with what has previously been reported for these two agents. Rates of ONJ were balanced and infrequent in both treatment groups (10 patients receiving denosumab as compared with 11 patients receiving Zometa). Infectious AEs were balanced between the two treatment arms (hazard ratio 0.95, 95 percent CI: 0.83, 1.08).