Jonathan C. Trent, MD, PhD, discusses the methods, design, and results from the INTRIGUE study in advanced gastrointestinal stromal tumor.
Jonathan C. Trent, MD, PhD, professor and associate director for Clinical Research at Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, Florida, discusses the methods, design, and results from the INTRIGUE study (NCT03673501) in advanced gastrointestinal stromal tumor (GIST).
Patients with advanced GIST who had disease progression on or intolerance to imatinib (Gleevec) were randomized in a 1:1 fashion to receive treatment with either to ripretinib (Qinlock) 150 mg once daily (QD) or sunitinib (Sutent) 50 mg QD for 4 weeks on and 2 weeks off in the international, randomized, multicenter, open-label, phase 3 INTRIGUE study.
The primary end point of the study was progression-free survival (PFS) based on independent radiologic review using modified RECIST, and secondary end points investigated were objective response rate and overall survival.
According to data from the study, the mediann PFS was not different between arms of patients with ctDNA not detectable and ctDNA detectable. These data suggest that for treatment with ripretinib or sunitinib, ctDNA not detectable was not a predictor of response.
0:10 | The INTRIGUE study was designed for patients with imatinib-resistant GIST. These patients were treated in the second-line of the study. Patients were randomized to either sunitinib or ripretinib in an open-label design with a 1 to 1 randomization and then followed for adverse events, followed for several efficacy parameters, and then allowed to cross over at the time of progression.
0:46 | Unfortunately, the study did not mean the end point of favorability for ripretinib. At this point in time, we can't say that ripretinib is any better than sunitinib in second-line GIST. We did notice that the tolerability of ripretinib seemed to be slightly better. Now ripretinib is in our National Cancer Center Network or NCCN guidelines for second-line therapy for patients who may not tolerate sunitinib.