Clinical trial design

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TURALIO: the only oral systemic therapy for TGCT with proven efficacy and safety in an international, phase 3, placebo-controlled trial1,2

ENLIVEN excluded patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5x upper limit of normal (ULN), and patients with known active or chronic infection with hepatitis B or C virus or human immunodeficiency virus.1

aPatients receiving TURALIO in Part 1 continued with their same dose in Part 2.2

bSecondary endpoints were assessed at week 25, except DOR.2

TURALIO was studied in patients with and without prior surgery1

Other baseline characteristics of patients in the ENLIVEN trial: The median age was 44 years (range: 18-79); 59% of patients were females; 88% of patients were White. Disease locations were knee (61%), ankle (18%), hip (11%), wrist (3%), foot (3%), and other (5%).

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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2021. 2. Tap WD et al; ENLIVEN investigators. Lancet. 2019;394(10197): 478-487.