Deciphera Pharmaceuticals, Inc. Receives European Commission Approval of QINLOCK? for Treatment of Fourth-Line Gastrointestinal Stromal Tumor
November 22, 2021 at 07:00 am EST
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Deciphera Pharmaceuticals, Inc. announced that the European Commission (EC) has approved QINLOCK? (ripretinib) in the European Union (EU) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. The EC decision is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein. In September 2021, QINLOCK was added as a fourth-line treatment for GIST patients progressing or intolerant to imatinib, sunitinib, and regorafenib to the ESMO-EURACAN-GENTURIS clinical practice guidelines for GIST. The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36). The most frequently observed adverse drug reactions (=25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting. In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK.
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.
DECIPHERA PHARMACEUTICALS, INC. 
