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No increased malignancy risk associated with omalizumab

Results from a large phase 4 FDA postmarketing study suggest that omalizumab therapy is not associated with an increased risk for malignancy.

In the Epidemiologic Study of Xolair: Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS), researchers examined the long-term safety of omalizumab (Xolair, Genentech/Novartis).

The prospective observational cohort study included patients (aged 12 years or older) with moderate-to-severe allergic asthma, with a 5-year follow-up. Two groups were assigned to either omalizumab (n=5,007) or no omalizumab (n=2,829). Primary outcomes included all confirmed, incident, study-emergent primary malignancies, including and excluding nonmelanoma skin cancer (NMSC).

Patients assigned omalizumab demonstrated a higher portion of those with severe asthma vs. those who were not on omalizumab (50% vs. 23%), according to data.

The crude malignancy rates were similar between groups, with a rate ratio of 0.84 (95% CI, 0.62-1.13) for all malignancies and 0.98 (95% CI, 0.71-1.36) for all malignancies excluding NMSC.

When additional adjustments were included, the researchers reported a hazard ratio of 1.09 (95% CI, 0.87-1.38) for all malignancies and 1.15 (95% CI, 0.83-1.59) for all malignancies excluding NMSC, among the two cohorts.

“Reported malignancies were predominantly solid tumors, with no unexpected histologic patterns observed,” the researchers wrote. “The most common cancers in both cohorts were skin, breast, and prostate cancer.”

These findings indicate that omalizumab was not associated with an increased risk for malignancy, according to researchers.

Disclosure: See the study for a full list of relevant financial disclosures.