AT A GLANCE

A new study published in the Journal of Clinical Oncology suggests that patients with advanced gastrointestinal stromal tumors who experience disease progression on imatinib and sunitinib intolerance could be treated with ripretinib.¹

“In the INTRIGUE phase III trial, adult patients with advanced gastrointestinal stromal tumors previously treated with imatinib were randomly assigned 1:1 to ripretinib 150 mg once daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off), explain study authors Heinrich et al. “In the primary analysis, median overall survival (OS) was not reached for either arm in either population.”

“In this study,” they add, “we report the final planned analysis of OS (key secondary endpoint), progression-free survival (PFS) on third-line therapy (second PFS; prespecified exploratory endpoint), and long-term safety.”

According to the authors, the final OS analysis was prespecified to occur with approximately 200 and ≥145 events in the overall and KIT exon 11 intention-to-treat (ITT) populations, respectively, with 211 and 151 OS events ultimately occurring in these populations by the data cutoff date. Notably, the median OS was similar between second-line ripretinib and sunitinib recipients in both populations (overall, 35.5 vs. 31.5 months; KITexon 11, 35.5 vs. 32.8 months). Further, the median second PFS (on third-line therapy) was similar between the ripretinib and sunitinib treatment arms for the overall ITT population (7.7 vs. 7.4 months).

“In conclusion, with 18 months of follow-up from the INTRIGUE phase III primary analysis, OS was similar between treatment arms in both ITT populations, and the ripretinib safety profile remained more favorable than [that of] sunitinib,” the authors explain. “The second PFS was also comparable between treatment arms in both ITT populations, suggesting that receiving second-line ripretinib did not adversely affect PFS on third-line therapy.”

“Patients who experience disease progression on imatinib and who are intolerant of sunitinib may have additional options with emerging therapy advances. These results confirm the efficacy and safety of ripretinib and demonstrate the potential benefit of ripretinib as an earlier treatment option for patients who do not tolerate treatment with sunitinib,” they conclude.

Reference

1.     Heinrich MC, Blay J-Y, Gelderblom H, et al. Updated overall survival and long-term safety with ripretinib versus sunitinib in patients with GI stromal tumor: final overall survival analysis from INTRIGUE. J Clin Oncol. 2025:JCO2402818.