Phase III Study: Xolair More Effective with Fewer Side Effects Than Oral Immunotherapy for Food Allergies
Genentech, a member of the Roche Group, has announced new positive results from Stage 2 and Stage 3 of the NIH-sponsored Phase III OUtMATCH study, providing further support for Xolair® (omalizumab) as a treatment for food allergies. In Stage 2 of the study, Xolair demonstrated greater effectiveness and fewer side effects compared to multi-allergen oral immunotherapy (OIT), marking the first head-to-head comparison between the two treatments. OIT involves gradually increasing the amount of the food allergen, starting with a very small dose. These results were particularly influenced by the higher rates of adverse events (AEs) that led to discontinuations in the OIT-treated group.
Genentech, a member of the Roche Group, recently presented exciting new data from the NIH-sponsored Phase III OUtMATCH study at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. This data adds to the growing body of evidence supporting the effectiveness of Xolair® (omalizumab) as a treatment for food allergies, particularly in comparison to oral immunotherapy (OIT). These findings, presented as late-breaking symposiums, focus on the use of Xolair for treating food allergies and the introduction of allergenic foods after stopping treatment.
Dr. R. Sharon Chinthrajah, a co-lead investigator of the OUtMATCH study and an associate professor of medicine at Stanford School of Medicine, highlighted the increasing prevalence of food allergies and the challenges faced by families managing strict dietary restrictions and constant vigilance. “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,” she stated. Dr. Chinthrajah’s words underscore the significance of these study results in offering new therapeutic insights for managing food allergies.
Levi Garraway, M.D., Ph.D., Chief Medical Officer at Genentech, expressed gratitude for the support from research institutions and the dedication of study participants. He said, “These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community.” The findings reflect the potential for Xolair to offer more effective treatment with fewer side effects than traditional oral immunotherapy.
Xolair Versus Multi-Allergen OIT: Stage 2 Results
The Phase III OUtMATCH study’s Stage 2 results represent the first head-to-head comparison between Xolair and multi-allergen OIT in the treatment of food allergies. The study showed that Xolair monotherapy was more effective and had fewer side effects compared to OIT. Specifically, 36% of patients treated with Xolair could tolerate at least 2,000 mg of peanut protein (roughly equivalent to eight peanuts) and two other allergens without experiencing an allergic reaction, compared to just 19% in the OIT group. This result was statistically significant with an odds ratio of 2.6 (p=0.031).
Stage 2 involved 117 patients (median age 7) who were initially treated with 8 weeks of open-label Xolair. Afterward, the patients were randomized to either multi-allergen OIT or placebo OIT while continuing Xolair for another 8 weeks. Following this period, the OIT group switched to placebo injections for 44 weeks, while the other group continued Xolair with placebo OIT. Patients were then re-challenged with their assigned allergens, including peanut and two other allergens from a list of milk, egg, wheat, cashew, hazelnut, and walnut. The primary endpoint was achieving tolerance to at least 2,000 mg of all three allergens, which was successfully met.
Notably, there were significant differences in adverse events (AEs) between the groups. Serious AEs occurred in 30.5% of the OIT group compared to 0% in the Xolair group. Additionally, 22% of the OIT group experienced AEs that led to treatment discontinuation, and 37.3% required epinephrine treatment, compared to just 6.9% in the Xolair group. These findings highlight the safety advantage of Xolair over OIT, especially in the context of managing food allergies.
Introduction of Allergenic Foods After Treatment: Stage 3 Results
Preliminary results from Stage 3 of the OUtMATCH study provide early insights into how patients may tolerate allergenic foods after discontinuing Xolair. This stage followed a 24-week open-label extension, with 60 patients from Stage 1 of the study entering Stage 3. These patients were no longer receiving Xolair and were given a treatment plan that included either dietary consumption of allergenic foods, rescue OIT, or food avoidance, based on their final food challenge results and personal preferences.
Of the 180 treatment plans developed, 82% included dietary consumption of allergenic foods. After 12 months of follow-up, many patients were able to incorporate allergenic foods into their diets, though success rates varied by allergen. For example, patients had a higher success rate for introducing milk, egg, and wheat into their diet (61-70%) compared to peanuts and tree nuts (38-56%). Success was defined as tolerating at least 300 mg of allergenic protein daily.
However, some patients returned to avoiding allergenic foods due to adverse events (AEs) like anaphylaxis and epinephrine use, and two cases of eosinophilic esophagitis were noted, potentially related to food consumption. Stage 3 of the study is still ongoing, and further analysis will provide a clearer understanding of how these treatments impact long-term food allergen tolerance.
Regulatory Approval and Ongoing Research
On February 16, 2024, the FDA approved Xolair for the reduction of allergic reactions, including anaphylaxis, resulting from accidental exposure to one or more foods in patients aged 1 year and older with IgE-mediated food allergies. This approval makes Xolair the first and only FDA-approved medication for reducing allergic reactions in individuals with food allergies. However, patients using Xolair are still advised to avoid the foods to which they are allergic, as Xolair is not intended for the emergency treatment of allergic reactions or anaphylaxis.
These latest data from the OUtMATCH study highlight Xolair’s potential to significantly improve the management of food allergies, offering patients a safer and more effective treatment option compared to traditional oral immunotherapy. As the study progresses, researchers continue to evaluate the long-term impact of Xolair on food allergy tolerance and the role it can play in improving quality of life for food allergy patients.
