Looking back at studies to reflect why it did not succeed can help us learn for future studies. This summary article helps explain the results of the Intrigue Study.
What is encouraging is that many months after this news, we see the company has analyzed the data further to see there is a specific mutational type that responds better to ripretinib second-line. As Deciphera embarks on their Pivotal Phase 3 INSIGHT study, we hope that further reflection will demonstrate how critical mutational testing is in the clinical pathway of the disease.
An excerpt from the abstract of the summary:
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 name QINLOCK®) 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).