Ripretinib trial misses primary endpoint for patients with gastrointestinal stromal tumor
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Ripretinib failed to prolong PFS compared with sunitinib among patients with gastrointestinal stromal tumor who received prior treatment with imatinib, according to results of the phase 3 INTRIGUE study released by the agent’s manufacturer.
Ripretinib (Qinlock, Deciphera Pharmaceuticals), a switch-control tyrosine kinase inhibitor, uses a dual mechanism of action that regulates the kinase switch pocket and activation loop to broadly inhibit KIT mutated kinases.
“While we are disappointed with these results ... we believe this was a robust, well-designed, and well-executed study,” Steve Hoerter, president and CEO of Deciphera, said in a company-issued press release.
The randomized, open-label, multicenter INTRIGUE study investigated the safety and efficacy of ripretinib vs. standard-of-care sunitinib (Sutent, Pfizer) among 453 patients with gastrointestinal stromal tumor (GIST) who had been treated with imatinib. GIST, a tumor that originates in the gastrointestinal tract, is diagnosed in approximately 4,000 to 6,000 adults in the United States each year.
Researchers assigned patients 1:1 to receive 150 mg ripretinib once a day or 50 mg sunitinib once a day for 4 weeks, followed by 2 weeks without sunitinib.
PFS by independent radiologic review according to modified Response Evaluation Criteria in Solid Tumors — first among a pre-specified subgroup of 327 patients with a KIT exon 11 primary mutation and then among the all-patient intent-to-treat population — served as the primary endpoint.
Results among the KIT-mutation subgroup showed median PFS of 8.3 months in the ripretinib vs. 7 months with sunitinib (HR = 0.88), a difference that did not reach statistical significance. In the all-patient population, median PFS was 8 months with ripretinib vs. 8.3 months with sunitinib (HR = 1.05), although PFS was not formally tested in this population because of the rules of the hierarchical testing sequence.
Hoerter said full results of INTRIGUE are expected to be presented at an upcoming medical meeting.
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