Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies
Roche (RHHBY) announced new positive data from Stage 2 and 3 of the NIH-sponsored phase III OUtMATCH study for Xolair in food allergy treatment. The study demonstrated Xolair's superiority over oral immunotherapy (OIT):
Key findings from Stage 2 showed:
- 36% of Xolair patients tolerated 2,000mg of peanut protein plus two other allergens vs 19% in OIT group
- Significantly fewer adverse events with Xolair (0% serious AEs vs 30.5% for OIT)
- Lower treatment discontinuation (0% vs 22%) and reduced epinephrine use (6.9% vs 37.3%)
Stage 3 preliminary results revealed 82% of treatment plans included dietary consumption of allergenic foods, with higher success rates for milk, egg, and wheat (61-70%) compared to peanuts and tree nuts (38-56%). Xolair received FDA approval on February 16, 2024, as the first medicine to reduce allergic reactions in patients aged 1+ with IgE-mediated food allergies.
Roche (RHHBY) ha annunciato nuovi dati positivi dalla Fase 2 e 3 dello studio OUtMATCH di fase III sponsorizzato dal NIH per il trattamento delle allergie alimentari con Xolair. Lo studio ha dimostrato la superiorità di Xolair rispetto all'immunoterapia orale (OIT):
I principali risultati della Fase 2 hanno mostrato:
- Il 36% dei pazienti trattati con Xolair ha tollerato 2.000 mg di proteine del nocciolo di arachidi più altri due allergeni rispetto al 19% nel gruppo OIT
- Significativamente meno eventi avversi con Xolair (0% eventi avversi gravi contro il 30,5% per OIT)
- Minore interruzione del trattamento (0% contro 22%) e ridotto uso di epinefrina (6,9% contro 37,3%)
I risultati preliminari della Fase 3 hanno rivelato che l'82% dei piani di trattamento includeva il consumo alimentare di cibi allergenici, con tassi di successo più elevati per latte, uova e grano (61-70%) rispetto a noccioli di arachidi e frutta secca (38-56%). Xolair ha ricevuto l'approvazione della FDA il 16 febbraio 2024, come il primo farmaco in grado di ridurre le reazioni allergiche in pazienti di età superiore a 1 anno con allergie alimentari mediate da IgE.
Roche (RHHBY) anunció nuevos datos positivos de las Fases 2 y 3 del estudio OUtMATCH de fase III patrocinado por los NIH para el tratamiento de alergias alimentarias con Xolair. El estudio demostró la superioridad de Xolair sobre la inmunoterapia oral (OIT):
Los hallazgos clave de la Fase 2 mostraron:
- El 36% de los pacientes tratados con Xolair toleraron 2,000 mg de proteína de maní más otros dos alérgenos frente al 19% en el grupo de OIT
- Significativamente menos eventos adversos con Xolair (0% eventos adversos graves frente al 30.5% para OIT)
- Menor interrupción del tratamiento (0% frente al 22%) y uso reducido de epinefrina (6.9% frente al 37.3%)
Los resultados preliminares de la Fase 3 revelaron que el 82% de los planes de tratamiento incluían el consumo dietético de alimentos alergénicos, con tasas de éxito más altas para leche, huevo y trigo (61-70%) en comparación con maní y nueces (38-56%). Xolair recibió la aprobación de la FDA el 16 de febrero de 2024, como el primer medicamento para reducir reacciones alérgicas en pacientes mayores de 1 año con alergias alimentarias mediadas por IgE.
로슈 (RHHBY)는 식품 알레르기 치료를 위한 Xolair의 NIH 후원 제3상 OUtMATCH 연구의 2상 및 3상에서 새로운 긍정적인 데이터를 발표했습니다. 이 연구는 Xolair가 경구 면역 요법(OIT)보다 우수하다는 것을 보여주었습니다:
2상에서의 주요 결과는 다음과 같습니다:
- Xolair 환자의 36%가 2,000mg의 땅콩 단백질과 두 가지 다른 알레르겐을 견딜 수 있었고, OIT 그룹에서는 19%에 불과했습니다.
- Xolair로 인한 부작용이 현저히 적었습니다 (심각한 부작용 0% 대 OIT 30.5%)
- 치료 중단이 적었습니다 (0% 대 22%) 및 에피네프린 사용 감소 (6.9% 대 37.3%)
3상의 초기 결과는 치료 계획의 82%가 알레르기 유발 음식의 식이 섭취를 포함하고 있으며, 우유, 계란 및 밀에 대한 성공률이 더 높았음을 보여주었습니다 (61-70%) 반면 땅콩 및 견과류는 (38-56%)로 나타났습니다. Xolair는 2024년 2월 16일 FDA 승인을 받았으며, IgE 매개 식품 알레르기가 있는 1세 이상 환자의 알레르기 반응을 줄이는 첫 번째 약물입니다.
Roche (RHHBY) a annoncé de nouvelles données positives des phases 2 et 3 de l'étude OUtMATCH de phase III parrainée par les NIH pour le traitement des allergies alimentaires avec Xolair. L'étude a démontré la supériorité de Xolair par rapport à l'immunothérapie orale (OIT) :
Les résultats clés de la phase 2 ont montré :
- 36% des patients traités avec Xolair ont toléré 2 000 mg de protéines d'arachide plus deux autres allergènes contre 19% dans le groupe OIT
- Moins d'événements indésirables graves avec Xolair (0% d'événements indésirables graves contre 30,5% pour l'OIT)
- Moins d'interruptions de traitement (0% contre 22%) et une utilisation réduite d'épinéphrine (6,9% contre 37,3%)
Les résultats préliminaires de la phase 3 ont révélé que 82% des plans de traitement incluaient la consommation d'aliments allergènes, avec des taux de réussite plus élevés pour le lait, les œufs et le blé (61-70%) par rapport aux arachides et aux noix (38-56%). Xolair a reçu l'approbation de la FDA le 16 février 2024, en tant que premier médicament à réduire les réactions allergiques chez les patients âgés de 1 an et plus présentant des allergies alimentaires médiées par IgE.
Roche (RHHBY) hat neue positive Daten aus Phase 2 und 3 der NIH-geförderten Phase-III-Studie OUtMATCH zur Behandlung von Nahrungsmittelallergien mit Xolair bekannt gegeben. Die Studie zeigte die Überlegenheit von Xolair gegenüber der oralen Immuntherapie (OIT):
Wichtige Ergebnisse aus Phase 2 zeigten:
- 36% der Xolair-Patienten tolerierten 2.000 mg Erdnusprotein plus zwei andere Allergene im Vergleich zu 19% in der OIT-Gruppe
- Deutlich weniger unerwünschte Ereignisse mit Xolair (0% schwere unerwünschte Ereignisse gegenüber 30,5% für OIT)
- Niedrigere Behandlungsabbrüche (0% gegenüber 22%) und reduzierte Anwendung von Epinephrin (6,9% gegenüber 37,3%)
Die vorläufigen Ergebnisse der Phase 3 zeigten, dass 82% der Behandlungspläne den Verzehr von allergenen Lebensmitteln beinhalteten, mit höheren Erfolgsraten für Milch, Eier und Weizen (61-70%) im Vergleich zu Erdnüssen und Nüssen (38-56%). Xolair erhielt am 16. Februar 2024 die FDA-Zulassung als erstes Medikament zur Reduzierung allergischer Reaktionen bei Patienten ab 1 Jahr mit IgE-vermittelten Nahrungsmittelallergien.
- First FDA-approved medicine for food allergy reactions
- 36% success rate vs 19% for OIT in allergen tolerance
- Superior safety profile with 0% serious adverse events vs 30.5% for OIT
- 82% of treatment plans allowed dietary consumption post-treatment
- Lower success rates for peanuts/tree nuts (38-56%) vs other allergens
- Patients must continue avoiding allergens while on treatment
- Some patients returned to food avoidance due to adverse events
- Cannot be used for emergency treatment of allergic reactions
- 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
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 (
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,
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
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.
For more information, please visit www.roche.com.
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