Deciphera issued a press release today sharing the results of an exploratory analysis of data using circulating tumor DNA (ctDNA) from the INTRIGUE Phase 3 clinical study of ripretinib and announcing plans to initiate INSIGHT, a new pivotal Phase 3 registrational study of QINLOCK. These new data were accepted and will be presented at a medical meeting later this month.
This new clinical data demonstrates that ripretinib provided compelling clinical efficacy to second-line GIST patients who harbored primary mutations in KIT exon 11 and secondary mutations in exon 17 and/or 18 only, and support our new Phase 3 study evaluating the potential for ripretinib to be an optimized therapy for this group of second line patients. Based on the results of this ctDNA analysis and discussions with regulators, Deciphera plans to initiate the INSIGHT pivotal Phase 3 clinical study of ripretinib versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17 and/or 18 only in the second half of 2023.
About the INSIGHT Study
The planned INSIGHT Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib with mutations in KIT exon 11 and 17/18 only (excluding patients with mutations in KIT exons 9, 13, or 14). In the study, 54 patients will be randomized 2:1 to either QINLOCK 150 mg once daily or sunitinib 50 mg once daily for four weeks followed by two weeks without sunitinib. The primary endpoint is PFS as determined by independent radiologic review using modified RECIST 1.1 criteria. Secondary endpoints include ORR as determined by independent radiologic review using modified RECIST 1.1 criteria and OS.
“We look forward presenting additional data from the overall ctDNA analysis at a medical meeting later this month. Given the strength of these results, and after consultation with the FDA, we plan to initiate our INSIGHT pivotal Phase 3 study in the second half of 2023.” – Matt Sherman, Chief Medical Officer (on Twitter)
See press release: https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-announces-results-ctdna-analysisand pdf.