In late December 2021, biopharmaceutical company Deciphera Pharmaceuticals, Inc. (“Deciphera”) shared that its therapy QINLOCK (ripretinib) was approved in the United Kingdom. The treatment is designed for adults with advanced gastrointestinal stromal tumors (GISTs). In particular, QINLOCK is designed for patients who have been previously treated with 3+ other therapies. Thus, the drug’s approval fulfills an immense unmet need for patients.
About QINLOCK
According to the European Medicines Agency (EMA), QINLOCK is an orally-administered tablet designed to treat GISTs. The EMA explains that:
The active substance in Qinlock, ripretinib, is one of a group of cancer medicines called receptor tyrosine kinase inhibitors [that] works by blocking the activity of receptors (targets) called KIT and PDGFRA on the surface of cancer cells. By blocking the action of the abnormal receptors, the medicine is expected to help to slow down the tumour growth.
The approval followed data from a Phase 1 trial and the Phase 3 INVICTUS clinical trial. During the studies, researchers found that:
- QINLOCK significantly improved progression-free survival as compared to a placebo. Additionally, the treatment lowered the chances of mortality and GIST progression by 85%.
- Altogether, the overall response and survival rates for QINLOCK were significantly higher than those receiving the placebo.
- QINLOCK was found to be relatively safe and well-tolerated. However, some adverse responses did occur. These included:
- Fatigue
- Nausea and vomiting
- Sudden hair loss
- Diarrhea or constipation
- Muscle pain
- Unintended weight loss
Gastrointestinal Stromal Tumors (GISTs)
Typically, spontaneous KIT or PDGFR gene mutations cause gastrointestinal stromal tumors (GISTs), though other unidentified gene mutations may also result in these tumors. These rare soft-tissue sarcomas form in the digestive tract. While GISTs are usually found in the stomach or small intestine, they may also form in the esophagus, colon, or rectum. Some GISTs are benign, though others are malignant. Most GIST diagnoses occur in those between ages 40-70. Symptoms include:
- Nausea and vomiting
- Anemia (low red blood cell count)
- Fatigue and general malaise
- Abdominal pain and swelling
- An abdominal mass
- Appetite loss
- Unintended weight loss
- Difficulty swallowing
- Gastrointestinal bleeding
- Note: This type of bleeding may lead to vomiting blood or bloody stool.
