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%).

As part of post-marketing requirements from the FDA, pharmacokinetic studies were conducted to further evaluate the effects of food when taking TURALIO

Pharmacokinetic data indicated that taking the 250 mg dose of TURALIO with a low-fat meal has no clinically significant difference compared to taking 400 mg on an empty stomach1

  • Lowering the dose of TURALIO and taking it with a low-fat meal (approximately 11 to 14 grams of total fat) helps to minimize the potential for drug overexposure in the event a patient did not carefully follow the dietary recommendations when taking the 400 mg dose of TURALIO
    • When TURALIO 400 mg is taken with a high-fat mealc instead of on an empty stomach, TURALIO exposure doubles
    • When TURALIO 400 mg is taken with a low-fat meald instead of on an empty stomach, TURALIO exposure increases by almost 60%
  • The current FDA-approved dose of TURALIO is 250 mg twice daily with a low-fat meal (approximately 11 to 14 grams of total fat)

cThe high-fat meal comprised 800 to 1000 calories with approximately 50% from fat (approximately 55 to 65 grams of total fat).1

dThe low-fat meal comprised approximately 400 calories with 25% from fat (approximately 11 to 14 grams of total fat).1

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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023. 2. Tap WD et al; ENLIVEN investigators. Lancet. 2019;394(10197): 478-487.