@gde_ya_1807 INTRIGUE is an international, multi-center study conducted in 122 active sites across 22 countries, where 453 patients with second-line GIST were randomized to receive ripretinib (n=226) or sunitinib (n=227). Key study results include:
• In patients with a KIT exon 11 primary mutation, ripretinib demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In the intention-to-treat (ITT) population (n=453), ripretinib demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p value=0.72).
• In patients with a KIT exon 11 primary mutation, ripretinib demonstrated an objective response rate (ORR) of 23.9% (n=39 of 163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p value=0.03). In the ITT population, ripretinib demonstrated an ORR of 21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib (nominal p value=0.27).
• Ripretinib was generally well tolerated. Fewer patients in the ripretinib arm experienced Grade 3/4 treatment-emergent adverse events compared to sunitinib (41.3% vs 65.6%).