INTRIGUE: ripretinib versus sunitinib in advanced gastrointestinal stromal tumour after imatinib
Ripretinib was not better than sunitinib as second-line treatment for gastrointestinal stromal tumour overall, but it was better tolerated and worked better in tumours with KIT exon 11 plus exon 17/18 secondary mutations, while sunitinib was better for exon 13/14 mutations.
Overview
Phase 3 open-label trial of 453 patients with advanced GIST after imatinib randomised to ripretinib or sunitinib.
Median progression-free survival was 8.3 versus 7.0 months in the intention-to-treat population (hazard ratio 0.91, not superior); ripretinib had fewer grade 3 to 4 adverse events (41 versus 66 percent) and better quality of life. Circulating tumour DNA analysis showed ripretinib superior in exon 11 plus 17/18 mutations and sunitinib superior in exon 11 plus 13/14 mutations.
- Median progression-free survival 8.3 vs 7.0 months; hazard ratio 0.91 (not superior).
- Exon 17/18 secondary mutations: ripretinib 14.2 vs 1.5 months; exon 13/14: sunitinib 15.0 vs 4.0 months.
Sunitinib remains the standard second-line treatment, with ripretinib as a better-tolerated alternative, and mutation-guided choice by circulating tumour DNA is being tested prospectively in INSIGHT.
- Failed its primary superiority endpoint.
- Mutation subgroup analysis was exploratory.
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