Onco360 Partners with Deciphera to Distribute QINLOCK for Advanced GIST Patients
Key Insights
Onco360 (search), the nation's leading independent specialty pharmacy, has been selected as a national pharmacy partner for QINLOCK (ripretinib), an FDA-approved treatment for advanced gastrointestinal stromal tumors (search).
QINLOCK is indicated for adult patients with advanced GIST (search) who have received prior treatment with 3 or more kinase inhibitors, including imatinib, based on the Phase III INVICTUS study.
The INVICTUS trial demonstrated significant efficacy with median progression-free survival of 6.3 months for ripretinib versus 1.0 month for placebo in 129 patients with relapsed or refractory GIST (search).
Onco360 (search), the nation's leading independent specialty pharmacy, has been selected as a pharmacy partner by Deciphera Pharmaceuticals (search) for QINLOCK (ripretinib), marking a significant expansion in access to this FDA-approved treatment for patients with advanced gastrointestinal stromal tumors (search) (GIST (search)).
The partnership enables Onco360 (search) to distribute QINLOCK to adult patients with advanced GIST (search) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The FDA approval was based on the Phase III INVICTUS study, which demonstrated the drug's efficacy in this heavily pretreated patient population.
"Onco360 (search) is grateful for the opportunity to partner with the team at Deciphera and become a specialty pharmacy provider for QINLOCK," said Benito Fernandez, Chief Commercial Officer. "With the addition of QINLOCK to our portfolio, we are continuing to build on our mission of improving the lives of patients battling cancer, rare, and complex disease."
Clinical Evidence Supporting QINLOCK
The FDA approval of QINLOCK was based on results from 129 patients with relapsed or refractory GIST (search) who were treated with ripretinib or placebo in the INVICTUS trial. The study's primary endpoint was progression-free survival (PFS), with compelling results favoring the active treatment.
The median progression-free survival was 6.3 months (95% CI 4.6-6.9) for the ripretinib group compared to 1.0 months (95% CI 0.9-1.7) for placebo, representing a substantial clinical benefit for patients with limited treatment options.
Mechanism of Action and Safety Profile
Ripretinib functions as a tyrosine kinase inhibitor that targets KIT (search) proto-oncogene receptor tyrosine kinase (KIT) and platelet-derived growth factor receptor A (PDGFRA (search)) kinase, including wild type, primary, and secondary mutations. The drug also inhibits other kinases in vitro, including PDGFRB (search), TIE2 (search), VEGFR2 (search), and BRAF (search).
The safety profile from the INVICTUS trial showed that ripretinib was generally well tolerated. The most common adverse reactions occurring in ≥20% of patients included alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase and decreased phosphate.
Expanding Access Through Specialty Pharmacy Partnership
Onco360 (search), founded in 2003, serves as the nation's largest independent oncology pharmacy and clinical support services company. The organization operates through a network of URAC- and ACHC-accredited oncology pharmacies, providing specialized services to oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers.
The company is headquartered in Louisville, Kentucky, and operates as a flagship specialty pharmacy brand of PharMerica Corporation (search), which provides institutional pharmacy, specialty infusion, and hospital services to healthcare facilities across the United States.