No difference observed in the risk of malignancy in patients exposed to omalizumab compared with controls

Previous pooled data from the omalizumab clinical trial programme (Phase I–III clinical studies) showed a numerical imbalance in cancers arising in omalizumab recipients. The incidence of malignancies in the omalizumab group was similar to that expected in the general population but higher compared with control, raising a question over omalizumab9s long-term safety. To fully address this potential safety concern, a further analysis was conducted using additional pooled data to examine malignancy in omalizumab-treated patients. We used data from 32 randomized, double-blind, placebo-controlled trials (RDBPCTs) to assess incidence of primary malignancy. 7432 patients (4254 omalizumab, 3178 placebo) were included. Total observation times censored at first malignancy were 3382 and 2473 patient-years for omalizumab- and placebo-treated patients, respectively, including treatment exposure durations of 2143.9 and 1689.1 patient-years, respectively. Malignancy rates and corresponding changes in rate ratios over time are shown in the Table. No specific cluster of neoplasm was identified. Results of this pooled analysis show a progressive reduction of the rate ratio to below unity in cancers arising in the omalizumab group compared with control in RDBPCTs, and suggest that a causal relationship between omalizumab therapy and cancer is unlikely.