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

• First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT)
• Results were featured as late-breakers at the 2025 AAAAI Annual Meeting
• Xolair is the only US FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies

Basel, 2 March 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.

“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities,” said 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. “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 Levi Garraway, M.D., Ph.D., 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.”

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.

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.

About Food Allergy
Food allergies have been on the rise for the past 20 years. Based on estimates for 2024, about 3.4 million children and 13.6 million adults in the US have been diagnosed with IgE-mediated food allergies. Allergic reactions can range from hives and swelling to life-threatening anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced an anaphylactic reaction at least once. It is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency room visits in the US each year.

About 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 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.

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.

About Xolair
Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is given as an injection under the skin, either by a healthcare provider or at home through self-injection (after initiating treatment in a healthcare setting). Healthcare providers will determine appropriate candidates for self-injection.

Xolair is designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimises the release of mediators throughout the allergic inflammatory cascade.

Food allergy is the fourth FDA-approved indication for Xolair. Other indications include moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). Since its initial approval in 2003, more than 850,000 people have been treated with Xolair in the US.

Genentech and Novartis are committed to helping people access the medicines they are prescribed and offer comprehensive services for people prescribed Xolair to help minimise barriers to access and reimbursement. For people who qualify, Genentech offers patient assistance programmes through Genentech Access Solutions. More information is available at 866-4ACCESS/866-422-2377.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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