Clinical Information

Clinical Information

Study Design

ENLIVEN: The only phase 3, placebo-controlled trial evaluating an oral systemic therapy for TGCT1,2

TURALIO was studied in a double-blind, placebo-controlled, international phase 3 trial.1,2

ENLIVEN study design and endpoints1,2,a

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RECIST, Response Evaluation Criteria In Solid Tumors; TGCT, tenosynovial giant cell tumor.

aENLIVEN excluded patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5 × upper limit of normal (ULN), patients
with malignant TGCT, and patients with known active or chronic infection with hepatitis B or C virus or human immunodeficiency virus.1,2

bPatients receiving TURALIO in part 1 continued with their same dose in part 2.2

primary-secondary-endpoints primary-secondary-endpoints

aSecondary endpoints were assessed at week 25, except DOR.1,2

Reflecting clinical experience: TURALIO was studied in patients with and without prior surgery1

Approximately half of the patients included in the study had no previous surgery related to TGCT (PVNS or GCT-TS).1

ENLIVEN excluded patients with a diagnosis of metastatic TGCT.2

Baseline characteristics of patients in ENLIVEN2,3,a
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TGCT, tenosynovial giant cell tumor.

aPercentages may not total 100% due to rounding.

Of the randomized patients, nearly half had not had prior
surgery and were not eligible for surgery for TGCT.1

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