First-ever head-to-head trial comparing Xolair and oral immunotherapy

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, have been released by Swiss pharma giant Roche (ROG: SIX).

The company noted that 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, said Roche, 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.