A double-blind, randomized, placebo-controlled, phase III trial has shown that ripretinib (a switch-control tyrosine kinase inhibitor) markedly improves progression-free survival in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. From across 29 specialized hospitals in 12 locations, 129 patients (>18 years old) were recruited and randomly assigned to receive either oral ripretinib 150 mg once daily (n = 85) or placebo once daily (n = 44). In the double-blind period, median progression-free survival was 6.3 months (95% CI 4.6–6.9) in the ripretinib group versus 1.0 month (95% CI 0.9–1.7) in the placebo group (hazard ratio 0.15, 95% CI 0.09–0.25; P < 0.0001). Ripretinib had an acceptable safety profile, with the most common grade 3 or 4 treatment-emergent adverse events including, among others, hypertension and fatigue in the ripretinib group.
Blay, J.-Y. et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. https://doi.org/10.1016/S1470-2045(20)30168-6 (2020)
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Ray, K. Ripretinib for advanced gastrointestinal stromal tumours. Nat Rev Gastroenterol Hepatol 17, 452 (2020). https://doi.org/10.1038/s41575-020-0336-2