Deciphera Pharmaceuticals announced that ripretinib (Qinlock®) failed to meet its primary endpoint in the phase 3 INTRIGUE trial for the treatment of gastrointestinal stromal tumors (GIST).
The INTRIGUE phase 3 clinical trial is a global, randomized, multicenter, open-label study to evaluate the use of ripretinib as a second-line treatment after imatinib. Ripretinib is currently approved as a fourth-line treatment for GIST.
“While we are disappointed with these results . . . we believe this was a robust, well-designed, and well-executed study,” Steve Hoerter, president and chief executive officer of Deciphera, said.
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The study’s primary endpoint was progression-free survival (PFS) rates for patients given 150 mg of ripretinib once daily compared to those treated with 50 mg of sunitinib once daily for 4 weeks. Patients were randomized 1:1 between the groups. Statistical analysis was to be performed first on study patients with KIT exon 11 primary mutation (n=327) and then be done on the all-patient intent-to-treat population (n=453).
Patients with KIT exon 11 mutations who were given ripretinib had a median PFS (mPFS) rate of 8.3 months, compared to 7.0 months in patients given sunitinib (hazard ratio [HR], .88; P =.360). In the intent-to-treat population, those receiving ripretinib had an mPFS rate of 8.0 months compared to 8.3 months in the sunitinib group (HR, 1.05; P =.715), although these values were not formally tested given the hierarchical testing sequence determined at the beginning of the trial.
“QINLOCK remains the standard of care and only approved therapy in patients with fourth-line GIST, and we are committed to ensuring that patients around the world in the fourth-line GIST treatment setting have access to QINLOCK,” Hoerter said.
PFS rates were determined by independent radiological review using the Modified Response Evaluation Criteria in Solid Tumors.
Hoerter said the full results from the study “are expected to be presented at an upcoming medical meeting.”
Deciphera Pharmaceuticals announces top-line results from the INTRIGUE phase 3 clinical study. News Release. Deciphera Pharmaceuticals; November 5, 2021.