The use of ripretinib (Qinlock®) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who were previously treated with 3 or more kinase inhibitors received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Steve Hoerter, president and chief executive officer of Deciphera Pharmaceuticals, said, “We are delighted that the CHMP has adopted a positive opinion for Qinlock, which could lead to Deciphera’s regulatory approval in the European Union.” He added, “This positive opinion highlights the CHMP’s recognition of the potential for Qinlock to help GIST patients who have received 3 prior therapies.”
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The marketing authorization application (MAA) for ripretinib is supported by efficacy and safety results from the pivotal phase 3 INVICTUS study and the phase 1 study of the treatment, respectively. Patients receiving ripretinib showed a median progression-free survival of 6.3 months compared to 1 month in individuals receiving a placebo. Moreover, ripretinib reduced the risk of disease progression or death by 85% (hazard ratio [HR], 0.15; P <.0001).
Ripretinib presented an objective response rate (ORR) of 9.4%, whereas in the placebo arm, it was 0%. The median overall survival (OS) was 15.1 months with ripretinib compared to 6.6 months for placebo. The risk of death was reduced by 64% (HR, 0.36) in patients treated with ripretinib. ORR and OS were determined as secondary endpoints using the modified RECIST assessment.
Ripretinib has emerged as a novel therapeutic for advanced, multiresistant GIST. It is a switch-pocket inhibitor with broad activity against KIT and PDGFRA oncoproteins. Its dual mechanism of action allows for the regulation of the kinase switch pocket and activation loop.
Reference
Deciphera announces positive CHMP opinion for Qinlock® for the treatment of fourth-line gastrointestinal stromal tumor. News release. Deciphera Pharmaceuticals, Inc.; September 17, 2021.
