Deciphera Pharmaceuticals, Inc. Announces Publication of Intrigue Phase 3 Clinical Study Results in Journal of Clinical Oncology
August 10, 2022 at 04:20 pm EDT
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Deciphera Pharmaceuticals, Inc. announced that the Journal of Clinical Oncologyhas published results from its INTRIGUE Phase 3 study of QINLOCK® (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib. Although QINLOCK did not offer a statistically significant improvement in progression-free survival (PFS) compared to sunitinib, QINLOCK showed meaningful clinical activity with fewer Grade 3/4 treatment-emergent adverse events (TEAEs) and improved tolerability. The article, titled Ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib (INTRIGUE): A randomized, open-label, phase III trial is now available online and will be published in a future print issue of the Journal of Clinical Oncology. INTRIGUE is an international, multi-center study conducted in 122 active sites across 22 countries, where 453 patients with second-line GIST were randomized to receive ripretinib (n=226) or sunitinib (n=227). Key study results include: In patients with a KIT exon 11 primary mutation, ripretinib demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In the intention-to-treat (ITT) population (n=453), ripretinib demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p value=0.72). In patients with a KITexon 11 primary mutation, ripretinib demonstrated an objective response rate (ORR) of 23.9% (n=39 of 163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p value=0.03). In the ITT population, ripretinib demonstrated an ORR of 21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib (nominal p value=0.27). Ripretinib was generally well tolerated. Fewer patients in the ripretinib arm experienced Grade 3/4 treatment-emergent adverse events compared to sunitinib (41.3% vs 65.6%). Patients receiving sunitinib were three times more likely to develop Grade 3 hypertension compared to patients receiving ripretinib (26.7% vs. 8.5%) and patients receiving sunitinib were seven times more likely to develop Grade 3 palmar-plantar erythrodysesthesia compared to patients receiving ripretinib (10.0% vs. 1.3%).
Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving ripretinib compared to patients receiving sunitinib. Patients receiving ripretinib experienced less deterioration in their ability to engage in either work or leisure activities during treatment, and fewer patients receiving ripretinib experienced moderate to extremely large impact on their lives due to skin toxicity across treatment cycles compared to patients receiving sunitinib. QINLOCK is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. The new drug application (NDA) for QINLOCK was based on positive results from the Phase 3 INVICTUS trial in patients with fourth-line and fourth-line plus GIST.
Deciphera Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines to improve the lives of people with cancer. The Company is leveraging its switch-control kinase inhibitor platform in kinase biology to develop a portfolio of medicines. The Company's QINLOCK, is a switch-control kinase inhibitor, engineered using its drug discovery platform and developed for the treatment of fourth-line gastrointestinal stromal tumor (GIST). In addition to QINLOCK, it has developed a robust pipeline of drug candidates using its switch-control kinase inhibitor platform, including vimseltinib and DCC-3116. Vimseltinib is an investigational, orally administered, potent, and highly-selective switch-control kinase inhibitor of colony stimulating factor 1 receptor (CSF1R) kinase for the potential treatment of tenosynovial giant cell tumor (TGCT). DCC-3116 is a Phase 1/2 inhibitor of ULK kinases being developed to inhibit autophagy.