Phase III study shows Xolair may be more effective with fewer adverse effects for the treatment of food allergies

Roche has announced new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provides further evidence supporting the role of Xolair^® (omalizumab) for the treatment of one or more food allergies.

Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer adverse effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.

OIT involves ingesting the food allergen, initially with a very small amount and gradually increasing the amount. These findings were largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.

Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient’s diet after stopping Xolair. These findings were featured as late-breaking symposiums at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

R. Sharon Chinthrajah, M.D., OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research, said, “These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients.”

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 paediatric 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.

In the US, Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

The OUtMATCH Study

The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is an National Institutes of Health (NIH)-sponsored, three-stage, multicentre, randomised, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years with peanut allergy and at least two other food allergies (including milk, egg, wheat, cashew, hazelnut, and walnut allergy).

The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 clinical sites across the US led by Johns Hopkins Children’s Center and co-led by Stanford School of Medicine. The study is also supported by Genentech and Novartis Pharmaceuticals Corporation.

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