EU approves Qinlock for advanced gastrointestinal stromal tumor – Deciphera Pharma
Deciphera Pharmaceuticals 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 Qinlock approval was supported by efficacy results from the primary analysis of the pivotal Phase III INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase I 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 (at least 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.