ArticleThe World Allergy Organization journal2026
Anaphylaxis events in the PIONEER study of avapritinib in indolent systemic mastocytosis.
Article in The World Allergy Organization journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03731260 (A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy
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18 authors.
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Abstract
Background: Patients with indolent systemic mastocytosis (ISM), a clonal mast cell disease primarily driven by the KIT D816V mutation, often have lifelong debilitating symptoms. Anaphylaxis is a common feature of the disease seen in up to half of patients. The effects of KIT D816V-targeted therapy on the incidence of anaphylaxis are unknown. Methods: We describe anaphylaxis events occurring in the study population of PIONEER (NCT03731260) during the 12-week screening and/or 24-week treatment period. This study had previously demonstrated the efficacy and safety of the oral, highly selective, KIT D816V inhibitor avapritinib compared with placebo in patients with moderate-to-severe ISM. Results: In total, 13/212 (6.1%) patients in PIONEER experienced anaphylaxis during screening or treatment (6 during screening, 5 during treatment, and 2 during both screening and treatment). Baseline demographics, clinical characteristics, and known triggers varied. During the randomized, placebo-controlled treatment period, 4/141 (2.8%) avapritinib-treated patients and 3/71 (4.2%) placebo-treated patients experienced anaphylaxis. Conclusions: Larger studies with longer-term follow-up are required to further confirm the effects of avapritinib on anaphylaxis in patients with SM.
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