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PIONEER phase II post hoc analysis: Anaphylaxis in patients with ISM receiving avapritinib
Results from a post hoc subanalysis of the phase II PIONEER study (NCT03731260), evaluating anaphylaxis events in 212 patients with moderate-to-severe indolent systemic mastocytosis (ISM) treated with avapritinib + best supportive care (BSC) vs placebo + BSC, were published in the World Allergy Organization Journal by Pongdee et al. The primary endpoint of the study was mean change in total symptom score. Analysis of anaphylactic reactions was a prespecified exploratory endpoint.
Key data: Overall, 6.1% of patients experienced anaphylaxis during screening and/or treatment. During the randomized treatment period, anaphylaxis occurred in 2.8% of patients receiving avapritinib and 4.2% of patients receiving placebo. Triggers for anaphylaxis included foods, medications, Hymenoptera venom, stress, and temperature. Improvements in quality of life (QoL) were experienced by 60% of patients receiving avapritinib compared with 66.6% of patients receiving placebo.
Key learning: Larger studies with longer-term follow-up are required to confirm the effects of avapritinib on anaphylaxis in patients with ISM.
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