A new clinical trial of ripretinib and sunitinib in patients with advanced gastrointestinal stromal tumors (GIST) with specific KIT mutations who were previously treated with imatinib is now open.
The 2-arm, randomized, open-label, multicenter phase 3 trial sponsored by Deciphera Pharmaceuticals will compare the efficacy of ripretinib to that of sunitinib in patients with GIST whose disease progressed despite imatinib treatment.
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An estimated 54 adult patients who have KIT exon 11 plus exon 17 and/or 18 mutations but no exon 9, 13, or 14 mutations will be enrolled in the trial.
Participants will be divided into 2 groups. Those in the first group will receive 150 mg of ripretinib once a day, while those in the second group will receive 50 mg of sunitinib once a day for approximately 48 months.
The primary outcome measure of the trial will be progression-free survival. Secondary outcome measures will be the objective response rate and the overall survival of the patients.
The study is not yet recruiting participants. It is estimated to start in August 2023 and be completed in December 2027.
GIST is a rare type of cancer that develops from the interstitial cells of Cajal that are located in the wall of the gastrointestinal tract.
Ripretinib marketed under the brand name Qinlock is a type 2 switch control tyrosine kinase inhibitor. It inhibits a broad spectrum of KIT and PDGFRA variants. Currently, it is approved by the US Food and Drug Administration (FDA) for the 4th-line treatment of advanced GIST.
Sunitinib marketed under the brand name Sutent is also a KIT and PDGFRA inhibitor as well as an inhibitor of other signaling molecules such as VEGFR, GDNF, FLT3, and CSF-1. The FDA approved it for the treatment of patients with imatinib-resistant GIST or who are intolerant to imatinib treatment.
Reference
A phase 3 study of ripretinib vs sunitinib in patients with advanced GIST with specific KIT exon mutations who were previously treated with imatinib (INSIGHT). US National Library of Medicine. Updated February 17, 2023. Accessed February 22, 2023.
