Study: Ripretinib Improves Quality of Life, Physical Functioning In Patients with Fourth-Line Advanced GIST

Patients with fourth-line gastrointestinal stromal tumor (GIST) who received ripretinib (Qinlock, Deciphera Pharmaceuticals) experienced improved quality of life as well as better physical and role functioning compared with patients who received a placebo, according to study results presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.

The Invictus study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating ripretinib in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. The patients were randomized to receive either 150 mg of ripretinib or placebo once daily.

Ripretinib is a kinase inhibitor indicated for adults with advanced GIST, approved by the FDA in May 2020.

“The recent FDA approval of Qinlock marked an important milestone for the entire GIST patient community who had been waiting for a new treatment option designed specifically for their disease,” said Deciphera Chief Medical Officer Matthew Sherman, MD, in a statement.

According to the phase 3 results, 5 key measures of quality of life were maintained in patients receiving ripretinib, compared with declining measures in patients who received the placebo. Furthermore, patients receiving ripretinib had consistently stable patient-reported outcomes, suggesting that they were able to maintain their quality of life.

Ripretinib was also associated with an increase in patients’ self-reported health statuses, including better physical and role functioning as well as higher perceptions of their overall health and quality of life.

The safety profile was also promising. When stratified by alopecia and palmar-plantar erythrodysesthesia syndrome (PPES), patient-reported assessments of function, overall health, and overall quality of life were stable.

For both alopecia and PPES, the majority of events were of lower severity grades and did not generally worsen over time. Grade 1-2 alopecia occurred in 44 patients (52%) and grade 1-2 PPES occurred in 18 patients (21%). No patients experienced grade 3 or higher PPES.

In patients receiving ripretinib, 8.2%, 24%, and 7.1% of patients experienced a treatment-emergent adverse event leading to treatment discontinuation, dose interruption, or dose reduction, compared with 12%, 21%, and 2.3%, respectively, in the placebo arm.

“Today’s ASCO presentations demonstrate that patients receiving Qinlock rated their overall health, quality of life, and physical and role function as better than that of patients receiving placebo,” Sherman said. “These insights into the GIST patient experience are invaluable to us as we establish a new standard of care in this area of unmet medical need.”

REFERENCE

Deciphera Pharmaceuticals Announces Presentations of Positive Patient Reported Outcomes Results from INVICTUS Phase 3 Study of Qinlock (ripretinib) in Patients with Fourth-Line Advanced GIST at the ASCO 2020 Virtual Scientific Program [news release]. Deciphera Pharmaceuticals; May 29, 2020. https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-announces-presentations-positive. Accessed June 10, 2020.