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Health state utility values and quality of life in patients receiving ripretinib in the phase 3 invictus trial and a real-world evidence study in china

Value in health(2022)

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摘要
Ripretinib is a switch-control tyrosine kinase inhibitor (TKI) approved for fourth-line (4L) treatment of patients with advanced gastrointestinal stromal tumor (GIST). In the INVICTUS study (NCT03353753) ripretinib demonstrated clinically meaningful benefit and a well-tolerated safety profile; patients reported stable or improved health-related quality of life (HRQoL) vs. placebo.1 We present health state utility values (HSUV) derived from EuroQol-5-Dimension (EQ-5D) questionnaires collected during both INVICTUS and a post-approval real-world evidence (RWE) study conducted in China. In INVICTUS, ≥4L GIST patients received ripretinib 150 mg (n=85) or placebo (n=44) once daily (QD).1 HRQoL was assessed using EQ-5D 5-Level (5L) at Day 1 of each cycle and end of treatment. Data were mapped using UK value sets to EQ-5D 3-Level (3L) utilities.2 In the RWE study, ≥4L GIST patients received ripretinib 150 mg QD (N=241). HRQoL was assessed monthly using EQ-5D-3L over 13 months. Data were mapped using Chinese value sets to EQ-5D-3L utilities.3 For both studies, mean HSUV were estimated for progression-free (PF) and progressed disease (PD) states. In INVICTUS, EQ-5D completion was >99%. HSUV for ripretinib vs. placebo were 0.75 vs. 0.73 for PF patients and 0.75 vs. 0.71 for PD patients. In the RWE study, EQ-5D completion was 65%. HSUV were 0.81 for PF patients and 0.67 for PD patients. HSUV calculated from the INVICTUS study were higher for patients receiving ripretinib vs. placebo. HSUV calculated from the RWE survey were similar, indicating high HRQoL for patients receiving ripretinib both within a clinical trial and under real-world conditions. These HSUV may be used to inform economic evaluations of novel therapies for patients with advanced GIST.
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