On October 12, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for QINLOCK (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib1 (Press release, Deciphera Pharmaceuticals, OCT 12, 2021, View Source [SID1234591090]).
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"We are committed to delivering this much-needed medicine to patients globally, and are thrilled that we have received approval in Switzerland, which is our seventh approval worldwide and the first in Europe," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Following a positive opinion earlier this month from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), we look forward to a potential approval from the European Commission (EC) for QINLOCK in the fourth quarter of this year, and to ensuring that GIST patients across the EU have access to this treatment option designed specifically for their disease."
The application for QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study of QINLOCK 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 as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)2. 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) 2.
The most frequently observed adverse drug reactions (≥20%) in patients treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, vomiting, lipase increased, muscle spasms, arthralgia, headache and dyspnoea1,2.
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 1,2.
About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST3,4.