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 U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies –

Genentech, a member of the Roche Group (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., 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 randomized 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 analyze 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 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.

In the U.S., Genentech 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 U.S. 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 U.S. 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 NIH-sponsored, three-stage, multicenter, randomized, 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 randomized 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 U.S. 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^® (omalizumab)

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 minimizes 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 U.S.

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

Indications and Important Safety Information

What is XOLAIR?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

• moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
• chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.
• food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.
• chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

• wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
• flushing, itching, hives, or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

• have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
• have sudden breathing problems (bronchospasm)
• have ever had a severe allergic reaction called anaphylaxis
• have or have had a parasitic infection
• have or have had cancer
• are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

• When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting.
• If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
• Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
• The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
• See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
• XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
• In people with asthma, CRSwNP and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
• In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
• Do not decrease or stop taking any of your other asthma, CRSwNP, hive medicine, food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
• You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
• If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

• Cancer. Cases of cancer were observed in some people who received XOLAIR.
• Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
• Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
• Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
• Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR:

• In adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
• In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.
• In adults with chronic rhinosinusitis with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.
• In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
• In people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information and Instructions for Use, or visit https://www.Xolair.com.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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