On September 17, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of QINLOCK (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib (Press release, Deciphera Pharmaceuticals, SEP 17, 2021, View Source [SID1234587879]).

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The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC), which has the authority to approve medicines in the European Union (EU), issues a decision on Deciphera’s marketing authorization application (MAA) for ripretinib.

"The majority of GIST patients who initially respond to traditional tyrosine kinase inhibitors eventually develop tumor progression due to secondary mutations, rendering this a disease area where novel treatment options are crucially needed," said Prof. Peter Reichardt, HELIOS Privatklinik Berlin-Buch, Germany. "In the Phase 3 INVICTUS study, ripretinib demonstrated significant clinical benefit in progression-free and meaningful overall survival."

"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," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "This positive opinion highlights the CHMP’s recognition of the potential for QINLOCK to help GIST patients who have received three prior therapies. If approved by the EC, ripretinib will be commercialized under the brand name QINLOCK."

The MAA is supported by efficacy results from the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, ripretinib demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). In addition, ripretinib demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36) 1.

About QINLOCK (ripretinib)

Ripretinib is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. Ripretinib also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST 2.

Ripretinib is approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib; by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib; and by the China National Medical Products Administration for the treatment of adult patients with GIST who have received prior treatment with three or more kinase inhibitors, including imatinib3,4,5,6.