Ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib: a plain language summary of the phase 3 INTRIGUE trial.

WHAT IS THIS SUMMARY ABOUT?: This document presents a patient-friendly summary of the phase 3 INTRIGUE clinical trial results, which were published in the Journal of Clinical Oncology in August 2022. A phase 3 trial is a study that tests the safety of a proposed treatment and how well it works compared with a standard treatment or a treatment with no active ingredient (also called a placebo). The aim of the INTRIGUE trial was to understand whether treatment with a drug called ripretinib (brand nameQINLOCK®) was superior to treatment with sunitinib (brand name SUTENT®) in participants with advanced gastrointestinal stromal tumor (also known as GIST) who cannot tolerate or whose disease progressed beyond first-line treatment with imatinib (brand name GLEEVEC®). The INTRIGUE trial included 453 participants with advanced GIST who had previously been treated with a tyrosine kinase inhibitor (also known as a TKI) medicine called imatinib. For patients with advanced GIST who cannot tolerate or whose disease progresses while taking imatinib, the recommended second-line TKI medicine is sunitinib. The recommended third-line TKI medicine is called regorafenib (brand name STIVARGA®). Ripretinib is currently the only medication approved for adults with advanced GIST who have previously been treated with 3 or more TKIs (fourth-line). WHAT WERE THE RESULTS?: The trial showed that ripretinib did not significantly increase the time that participants survived without their cancer getting worse (progression-free survival or PFS) over sunitinib. However, participants treated with ripretinib had similar PFS to those treated with sunitinib. Importantly, treatment with ripretinib resulted in fewer severe adverse events, or side effects, compared with sunitinib, and participants reported better quality of life with ripretinib compared with sunitinib. WHAT DO THE RESULTS MEAN?: Treatment with ripretinib, after imatinib stops working or can no longer be tolerated, provided similar PFS for participants with advanced GIST and had fewer severe adverse events compared with sunitinib. Sunitinib is the only medication currently approved for use as a second-line treatment in patients with advanced GIST previously treated with imatinib. With more investigation, ripretinib could be a treatment option for these patients. Patients should always talk to their medical team before making any decisions about their treatment.

Ripretinib for advanced gastrointestinal stromal tumor: Plain language summary of the INVICTUS study.

The purpose of this summary is to help you understand the results of the INVICTUS study originally published in the journal Lancet Oncology. INVICTUS is a clinical study which looked at ripretinib as a potential treatment for advanced gastrointestinal stromal tumor, also known as GIST. GIST is a type of cancer that starts in the digestive tract, also known as the gastrointestinal tract. In the study, all participants had advanced GIST and needed a fourth-line (or greater) treatment following the failures of three previous treatments. The study looked at how well ripretinib worked compared with a nonactive medicine (known as a placebo) and at the side effects. Participants were given ripretinib at a dose of 150 mg once a day or a placebo. The results of the INVICTUS study showed ripretinib increased the length of time participants survived before their cancer got worse. Treatment with ripretinib was associated with side effects that varied in severity. The results of this study led to ripretinib, also known by the brand name Qinlock®, being approved in the USA by regulators as the only medication for adults with advanced GIST who have previously been treated with 3 or more types of treatment called tyrosine kinase inhibitors. ClinicalTrials.gov NCT number: NCT03353753.