The Food and Drug Administration (FDA) has approved Qinlock™ (ripretinib; Deciphera) for the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Ripretinib is a tyrosine kinase inhibitor that inhibits KIT proto-oncogene receptor tyrosine kinase and platelet derived growth factor receptor A kinase. The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 INVICTUS study that evaluated the efficacy and safety of ripretinib in 129 adults with advanced GIST who had received prior treatment with imatinib, sunitinib, and regorafenib.
Patients were randomized 2:1 to receive ripretinib 150mg (n=85) or placebo (n=44) once daily until disease progression or unacceptable toxicity. The primary end point was progression free survival (PFS) at 15 months, based on an independent radiologic review using a modified RECIST.
Results demonstrated that treatment with ripretinib significantly reduced the risk of disease progression or death by 85% (hazard ratio [HR] 0.15; 95% CI, 0.09-0.25; P <.0001) with a median PFS of 6.3 months compared with 1 month in the placebo arm. Moreover, median overall survival (secondary end point) was 15.1 months in the ripretinib arm vs 6.6 months in the placebo arm (HR 0.36; 95% CI, 0.21-0.62).
With regard to safety, the most common adverse reactions included alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. Treatment with ripretinib was also associated with new primary cutaneous malignancies, hypertension, and cardiac dysfunction.
“Today’s approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
The FDA previously granted Priority Review, Fast Track, Breakthrough Therapy, and Orphan Drug designations to Qinlock for this indication.
Qinlock will be supplied as 50mg tablets in 90-count bottles in the next week.
For more information visit qinlock.com.