New England Journal of Medicine publishes phase III data showing Xolair (omalizumab) significantly reduced allergic reactions across multiple foods in people With food allergies – Genentech/Roche

Genentech, a member of the Roche Group, announced data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM) and featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting .

The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year. Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.

The FDA recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data. “Over the past 35 years, I have seen how debilitating food allergies can be for patients and their loved ones, as they are consumed by the fear of accidental exposure,” said Robert Wood, M.D., director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, and principal investigator of the OUtMATCH study. “While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy. The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure.” “Living with food allergies has a profound impact on patients and their families, causing significant stress and requiring constant vigilance,” said R. Sharon Chinthrajah, M.D., associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research and OUtMATCH co-lead study investigator.

“The OUtMATCH study demonstrated that anti-IgE therapy increased most patients’ threshold for an allergic reaction. This presents an important new treatment option for patients and families in its potential to reduce the risk of allergic reactions from accidental exposures they may face in day-to-day life.”

One hundred eighty patients ages 1 to 55 years old entered Stage 1 of the OUtMATCH study unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg of at least two other food proteins among milk, egg, cashew, walnut, hazelnut and wheat. After 16 to 20 weeks of treatment with Xolair or placebo, each participant completed four separate blinded food challenges (including a placebo ingredient) to assess patients’ ability to consume a single dose of at least 600 mg of peanut protein (primary endpoint), and a single dose of at least 1,000 mg of milk, egg, wheat, cashew, hazelnut or walnut protein (secondary endpoints) without experiencing moderate to severe allergic reactions. Results showed that, compared to placebo, a statistically significant (p<0.001) higher proportion of patients receiving Xolair were able to consume at least 600 mg of peanut protein and at least 1,000 mg of milk, egg and cashew protein without experiencing moderate to severe allergic reactions. Additionally, compared to placebo, a higher proportion of patients receiving Xolair were also able to consume at least 1,000 mg of walnut, hazelnut and wheat protein without experiencing moderate to severe allergic reactions.

Additionally, out of three adult OUtMATCH participants, two completed Stage 1 of the study; the adult who received Xolair met the primary endpoint compared to the placebo-enrolled adult patient. Adverse event rates in the study were similar between Xolair and placebo. The most common adverse event in Xolair-treated children and adolescents was injection site reaction (9%).

“The Phase III OUtMATCH results represent a major advance and reinforce our commitment to addressing critical gaps in care for conditions like food allergy,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Now recently FDA-approved, Xolair provides a new way to help manage food allergies for children and adults who live with the constant fear of life-threatening allergic reactions.” While efficacy cannot be established from uncontrolled, open-label studies, for 38 children who continued Xolair for 24-28 weeks in an open-label extension, the percentage of patients who were able to consume 600 mg or more of peanut protein and 1,000 mg or more of egg, milk and/or cashew protein without moderate to severe dose-limiting symptoms was maintained..

About 3.4 million children and 13.6 million adults in the U.S. will have been diagnosed with IgE-mediated food allergies, based on estimates for 2024. Food allergy prevalence has been on the rise for the past 20 years. There are 160 different foods that cause IgE-mediated food allergy. Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S. each year.

On February 16, 2024, the FDA approved Xolair for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.

See- “Omalizumab for the Treatment of Multiple Food Allergies”- Robert A. Wood, M.D., Alkis Togias, M.D., Scott H. Sicherer, M.D., Wayne G. Shreffler, M.D., Ph.D., Edwin H. Kim, M.D., et al.-February 25, 2024 . DOI: 10.1056/NEJMoa2312382.