ABSTRACT Background In a bridging study of INTRIGUE, second‐line ripretinib demonstrated comparable progression‐free survival (PFS) and favorable safety versus sunitinib in Chinese patients with advanced gastrointestinal stromal tumor. Overall survival (OS) was highly immature at the time of primary analysis. This updated analysis assessed long‐term OS of ripretinib versus sunitinib. Methods This phase 2, multicenter, randomized, open‐label study in China enrolled patients with gastrointestinal stromal tumor previously treated with imatinib, randomized (1:1) to ripretinib 150 mg once daily by continuous dosing in 42‐day cycles or sunitinib 50 mg once daily in 42‐day cycles (four weeks on/two weeks off). The updated analysis assessed OS and PFS on third‐line therapy in all‐patient intention‐to‐treat and KIT exon 11‐mutated intention‐to‐treat (Ex11 ITT) populations. Results Of 108 patients randomized, 54 received ripretinib and 54 sunitinib; 70 had a primary KIT exon 11 mutation (ripretinib, n = 35; sunitinib, n = 35; Ex11 ITT). By December 30, 2024, in all‐patient intention‐to‐treat population, median OS was 43.3 months with ripretinib and 29.9 months with sunitinib (hazard ratio, 0.681; 95% CI, 0.411–1.126; nominal p = .134). In the Ex11 ITT population, median OS was 43.3 months with ripretinib and 28.6 months with sunitinib (hazard ratio, 0.552; 95% CI, 0.291–1.047; nominal p = .065). PFS on third‐line therapy was comparable between treatment arms in both populations. Conclusions After two additional years of follow‐up, ripretinib showed a trend toward clinically meaningful OS benefit versus sunitinib in the Ex11 ITT population. Second‐line ripretinib does not appear to affect third‐line treatment efficacy.
Zhang et al. (Mon,) studied this question.