Roche’s asthma drug Xolair appears to be safer and more effective than oral immunotherapy at treating adults and children with one or more food allergies.
With new data from the Phase III OUtMATCH trial, Roche and its subsidiary Genentech continue to establish the IgE blocker as the leading treatment option for food allergies.
The trial found that 36% of patients treated with Xolair, given every two weeks or every four weeks depending on randomization, could tolerate at least 2,000 mg of peanut protein—corresponding to around eight peanuts—and two other food allergens without developing allergic reactions, according to data presented Sunday at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. In contrast, only 19% of comparators who underwent oral immunotherapy (OIT), which involved gradually increasing exposure to the allergen, achieved this outcome. The difference was statistically significant, with a p-value of 0.031, as per Roche’s news release.
The company pointed out that Xolair’s significant advantage was “largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.” More than 30% of OIT participants experienced serious adverse events, while 22.2% of these patients had to discontinue treatment due to toxicities. In contrast, none of the Xolair-treated patients developed severe side effects or had to drop out of the study.
Sunday’s OUtMATCH readout also showed that after treatment with Xolair, “many” study participants were able to introduce allergic foods into their diets—though those attempts were hit or miss. Milk, egg and wheat appeared to be more tolerable for patients who had undergone Xolair treatment in comparison to peanuts and tree nuts, which were more difficult.
Still, many patients eventually had to continue avoiding their allergic foods “due to AEs and other factors,” such as anaphylaxis and the need for epinephrine treatment, even with Xolair available. This phase of the OUtMATCH study is ongoing.
Xolair, designed to be administered via an injection under the skin, is a humanized monoclonal antibody that disrupts the interaction between IgE and its corresponding receptor, disrupting the allergic cascade. The drug was first approved in 2003 for moderate-to-severe asthma and has since won the FDA’s nod for chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
In February 2024, the regulator also gave its go-ahead for the use of Xolair to ease allergic reactions following accidental exposure in adults and children with IgE-mediated food allergies, making it the “first and only” FDA-approved treatment for people with one or more food allergies, Roche said at the time.
This approval also covers the use of Xolair for anaphylaxis but does not qualify the biologic as an emergency treatment.
