Deciphera Pharmaceuticals announced that ripretinib (Qinlock®) received approval as a fourth-line treatment option for patients with gastrointestinal stromal tumors (GISTs).
This approval from the European Commission allows the use of ripretinib for the treatment of adults with GISTs who have already received 3 or more kinase inhibitors including imatinib in all 27 countries of the European Union (EU).
“The European Commission’s approval of QINLOCK marks the eighth regulatory approval of this transformative medicine worldwide and is an important milestone for patients with advanced GIST in the EU who are in need of a new treatment option,” Steve Hoerter, president and chief executive officer of Deciphera said.
“For patients with advanced GIST, the EC approval of QINLOCK offers a much-needed therapeutic option for these patients for whom existing agents have only limited benefit,” Sebastian Bauer, MD, medical oncologist at the West German Cancer Center in Essen added.
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The approval was supported by data collected from the phase 3 INVICTUS trial (NCT03353753) and safety data collected from a previous phase 1 trial. During the INVICTUS trial, patients who received ripretinib had a median progression-free survival of 6.3 months compared to a median of 1.0 months for patients who received a placebo.
Patients in the treatment group also had an objective response rate of 9.4% compared to 0% in the placebo group (P =.0503). The median overall survival was also increased for patients taking ripretinib compared to placebo (15.1 months vs 6.6 months). Treatment also reduced the risk by 64% and the risk of disease progression or death by 85%.
“The INVICTUS study evaluated QINLOCK in patients who had exhausted all approved options. QINLOCK showed a highly meaningful benefit, not only in terms of disease control, but for the first time in a randomized GIST trial, also overall survival when compared to best supportive care,” Dr. Bauer said. “It is also noteworthy that QINLOCK maintained quality of life in this very advanced group of patients.”
“The treatment of advanced GIST patients who initially respond to traditional tyrosine kinase inhibitors but eventually develop tumor progression due to secondary mutations has remained an area of high unmet medical need in Europe,” Jean-Yves Blay, MD, PhD, professor of medicine at the Université Claude Bernard in Lyon, France, said. “This product brings a new hope for those patients who failed currently approved kinase inhibitors.”
Deciphera receives European Commission approval of QINLOCK® for the treatment of fourth-line gastrointestinal stromal tumor. News Release. Deciphera Pharmaceuticals; November 22, 2021.