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Association details:
| Biomarker: | KIT exon 11 mutation |
|---|---|
| Cancer: | Gastrointestinal Stromal Tumor |
| Drug: | Qinlock (ripretinib) (c-KIT inhibitor, FLT3 inhibitor, PDGFR α inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Deciphera Pharmaceuticals Announces Results from ctDNA Analysis from INTRIGUE Phase 3 Clinical Study Demonstrating Substantial Clinical Benefit of QINLOCK® in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 Only
Published date:
01/03/2023
Excerpt:
Deciphera Pharmaceuticals, Inc...announced findings of a planned exploratory analysis of data from the INTRIGUE Phase 3 clinical study of QINLOCK using circulating tumor DNA (ctDNA) from a subgroup of patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib who harbor mutations in KIT exon 11 and 17/18 only..Patients with mutations in KIT exon 11 and exon 17/18 only had substantially improved progression-free survival (PFS), objective response rate (ORR), and overall survival (OS) with QINLOCK versus sunitinib.
Trial ID:
Source:
Title:
Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial
Published date:
08/10/2022
Excerpt:
Objective response rate was higher for ripretinib versus sunitinib in the KIT exon 11 ITT population (23.9% v 14.6%, nominal P = .03). Ripretinib was associated with a more favorable safety profile, fewer grade 3/4 treatment-emergent adverse events (41.3% v 65.6%, nominal P < .0001), and better scores on patient-reported outcome measures of tolerability...meaningful clinical activity, fewer grade 3/4 treatment-emergent adverse events, and improved tolerability were observed with ripretinib.
DOI:
10.1200/JCO.22.00294
Trial ID:
Source:
Title:
Clinical activity of ripretinib in patients with advanced gastrointestinal stromal tumor harboring heterogenous KIT/PDGFRA mutations in the phase 3 INVICTUS study
Published date:
09/09/2021
Excerpt:
Patients receiving ripretinib demonstrated progression-free survival (PFS) benefit vs placebo regardless of mutation status (hazard ratio 0.16) and in all assessed subgroups in Kaplan-Meier PFS analysis (exon 11, P <0.0001; exon 9, P=0.0023; exon 13, P <0.0001; exon 17, P <0.0001)....Ripretinib provided clinically meaningful activity across mutation subgroups in patients with advanced GIST...
DOI:
10.1158/1078-0432.CCR-21-1864
Trial ID:
Source:
Title:
Ripretinib therapy in treating advanced gastrointestinal stromal tumors: A single-center analysis in a real-world setting.
Published date:
05/25/2023
Excerpt:
This study is aimed to investigate the efficacy and safety of ripretinib….Patients with a primary mutation in KIT exon 11 (P = 0.019), better ECOG performance status (P＜0.001), fewer tumors (P = 0.014), and a younger age (P = 0.039) had longer OS.
DOI:
10.1200/JCO.2023.41.16_suppl.e23514
Source:
Title:
Efficacy and safety of ripretinib vs sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: A phase 2 multicenter, randomized, open-label study in China.
Published date:
01/17/2023
Excerpt:
ORR by IRR was numerically higher for ripretinib than sunitinib (29.6% vs 20.4%). Median OS was not reached in either arm. In Ex11 ITT population, a longer PFS by IRR (HR 0.46, 95% CI 0.23, 0.92; p=0.03...a numerically higher ORR by IRR (37.1% vs 22.9%) were observed for ripretinib vs sunitinib....Similar to the INTRIGUE trial, ripretinib demonstrated comparable overall efficacy and favorable safety vs sunitinib as 2L therapy in Chinese pts with advanced GIST. 2L GIST pts harboring a KIT exon 11 mutation may benefit from ripretinib vs sunitinib.
DOI:
10.1200/JCO.2023.41.3_suppl.803
Trial ID:
