Andreas Reiter, Jason Gotlib, Iván Álvarez-Twose, Deepti Radia, Johannes Lübke, Priyanka Bobbili ScD, Aolin Wang, Chelsea Norregaard, Saša Dimitrijević, Erin Sullivan, Melinda Louie-Gao, Juliana Schwaab, Ilene Galinsky, Cecelia Perkins, Wolfgang Sperr, Priya Sriskandarajah, Andi Chin, Selvam Sendhil, Mei Sheng Duh ScD, Peter Valent, Daniel DeAngelo
CONTEXT: Avapritinib, a selective KIT D816V inhibitor, was approved by the FDA and EMA (by EMA only after prior systemic therapy) for treating adults with advanced systemic mastocytosis (AdvSM) based on the single-arm phase 1 EXPLORER (NCT02561988) and phase 2 PATHFINDER (NCT03580655) studies. SM-AHN is the most common AdvSM subtype, however, there is no randomized controlled trial that compares the efficacy of avapritinib versus best available therapy (BAT) in this population. OBJECTIVE: This study (NCT04695431) compared overall survival (OS) in patients with SM-AHN treated with avapritinib in EXPLORER and PATHFINDER versus patients treated with BAT in standard clinical practice...
October 2022: Clinical Lymphoma, Myeloma & Leukemia