Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies – Roche

Roche announced new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase III OUtMATCH study, which provide 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 side 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.

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 pivotal Stage 1 involved 180 participants, who were randomised to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. After 16 to 20 weeks of treatment, each participant completed blinded food challenges in a carefully controlled setting. Stage 1 of the study served as the basis for the FDA approval of Xolair for children and adults with one or more food allergies, and the data were published in the New England Journal of Medicine in February 2024.

Xolair versus multi-allergen OIT for the treatment of food allergies: Stage 2 results of the OUtMATCH study

In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein (about eight peanuts) and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group (odds ratio=2.6, P=0.031).

After Stage 1 of the OUtMATCH study, which served as the basis for the FDA approval of Xolair for the treatment of food allergies, 117 patients (median age: 7 years) moved on to Stage 2, where they all initially received 8 weeks of open-label Xolair.  Patients were then randomised to receive either multi-allergen OIT or placebo OIT while continuing Xolair for another 8 weeks. After that, the OIT group switched to placebo injections for an additional 44 weeks while the other group continued Xolair with placebo OIT.

After the full treatment period, patients were re-challenged with their three study-specific foods (peanut and two other foods from milk, egg, wheat, cashew, hazelnut, and/or walnut). The primary endpoint was tolerance of 2,000 mg or more for all three foods, which was met. Superiority was also demonstrated for numerous secondary endpoints, including tolerating two or more foods (P=0.004). These findings were largely driven by the high rates of AEs in the OIT group. Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%) and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.

The introduction of allergenic foods after treatment with Xolair: initial Stage 3 results of the OUtMATCH study

The first 60 patients (median age: 8.5 years) from Stage 1 of the OUtMATCH study entered a 24-week open-label extension followed by Stage 3, which included dietary consumption of allergenic foods, rescue oral immunotherapy or food avoidance, depending on the results of the final food challenge and patient preferences. Patients were no longer receiving Xolair.

Each of the 60 patients received a treatment plan for each of their three study allergens.  Of the 180 treatment plans, 82% (n=148) of initial treatment plans included dietary consumption of allergenic foods. After 12 months of follow-up, many patients were able to introduce allergenic foods in dietary form, although success rates were higher for milk, egg and wheat (61-70%) than for peanuts and tree nuts (38-56%). Success was defined as tolerating a median daily consumption of at least 300 mg of allergenic protein. The study found that reduced consumption of allergenic foods appeared to be related to symptoms and other factors (such as taste and aversion), with no clear predictors of dietary consumption success. Many patients returned to avoidance due to AEs and other factors. AEs included anaphylaxis, epinephrine use and two cases of eosinophilic esophagitis possibly related to dietary consumption. Stage 3 is ongoing and study investigators are continuing to analyse data from additional patients who completed Stage 2 and then entered Stage 3.

“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities,” said Dr. R. Sharon Chinthrajah,  OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research. “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.”

“These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We are deeply grateful to the leading research institutions who partnered with us on this groundbreaking study, along with the inspiring dedication of the study’s participants and their families.”