Dr. Serrano on the Rationale for the INVICTUS Trial in Advanced GIST

César Serrano-García, MD, principle investigator, Translational Sarcoma Research Program, faculty member, Sarcoma Unit, Vall d’Hebron Hospital, Barcelona, Spain, discusses the rationale for the phase 3 INVICTUS trial in patients with advanced gastrointestinal stromal tumors (GIST).

Of more than 70 sarcoma subtypes, GIST is the most common, according to Serrano-García. Additionally, GIST is associated with KIT and PDGFRα oncogenic driver mutations that can be targeted with approved agents such as imatinib (Gleevec), sunitinib (Sutent), and regorafenib (Stivarga).

However, patients often progress on these agents, adds Serrano-García. Results from the INVICTUS trial demonstrated an 85% reduction in the risk of disease progression or death with the novel, oral KIT and PDGFRα TKI ripretinib (Qinlock) compared with placebo in heavily pretreated patients with advanced GIST.

The findings led to the May 15, 2020 FDA approval of ripretinib for use in patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitor therapies including imatinib.