%0 Journal Article %A Mark Eisner %A Mary Miller %A Will Chou %A Abdelkader Rahmaoui %A Mary Bradley %T Omalizumab and malignancy: Interim results from the EXCELS study %D 2011 %J European Respiratory Journal %P p3954 %V 38 %N Suppl 55 %X Background: Omalizumab is a biologic for the treatment of moderate-to-severe persistent allergic asthma that is inadequately controlled with inhaled corticosteroids. At the time of FDA approval, the incidence of malignant neoplasms was higher among patients who had received omalizumab (0.5%) compared to placebo (0.2%) in clinical trials.Objective: The EXCELS study is an FDA postmarketing commitment to evaluate the long-term safety of omalizumab.Methods: EXCELS is an ongoing prospective observational study of approximately 5000 omalizumab-treated and 2500 non-omalizumab-treated moderate-to-severe persistent allergic asthma patients aged ≥12 years from 448 US centers who are followed for up to 5 years. All reported potential malignancies are reviewed by an independent oncology panel. The primary analysis includes confirmed, incident study-emergent primary malignancies.Results: This analysis of malignancy rates was based on interim study report 6 (data through 11/30/2010) which comprises 18,860 person-years in the omalizumab cohort and 10,947 person-years in the non-omalizumab cohort. Both cohorts had an average follow-up of 3.8 person-years. The incidence of study-emergent primary malignancy was 12.78 and 14.48 per 1000 person-years in the omalizumab and the non-omalizumab cohorts, respectively, corresponding to a rate difference of -1.70 per 1000 person-years (95% CI: -6.43 to 2.21).Conclusions: In this analysis, the incidence of malignancy was similar in the omalizumab and non-omalizumab cohorts. These interim results are preliminary and the study is still ongoing. Because the study is observational, selection and other biases cannot be excluded.Funding Source: Genentech, Inc and Novartis Pharmaceuticals Corp. %U