Deciphera Announces Approval of QINLOCK® in the United Kingdom for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
– QINLOCK Significantly Reduced the Risk of Disease Progression or Death by 85% and Showed Clinically Meaningful Overall Survival in the INVICTUS Phase 3 Study –
“The approval of QINLOCK in the
The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK 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)2. Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)2 In addition, QINLOCK 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)2.
The most frequently observed adverse drug reactions (≥25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting1,2.
In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK2.
About QINLOCK (ripretinib)
QINLOCK 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. QINLOCK 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 mutation3,4. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST3,4.
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the potential for QINLOCK the transform the treatment of advanced GIST and establish a new standard of care in the
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of
QINLOCK Summary of Product Characteristics.
- Blay JY, Serrano C, Heinrich MC et al. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): A double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2020; 21:923–934.
- Smith B et al., Ripretinib (DCC-2618) is a switch control kinase inhibitor of a broad spectrum of oncogenic and drug-resistant KIT and PDGFRA variants. Cancer Cell 2019; 35:738–751.
Bauer S, Heinrich M, et al. Clinical activity of ripretinib in patients with advanced gastrointestinal stromal tumor harboring heterogenous KIT/PDGFRA mutations in the phase 3 INVICTUS study.
Clinical Cancer Research2021; 27:6333-6342.
Deciphera Press Release: Deciphera Announces Australian Therapeutic Goods Administration’s Approval of QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online]
July 14, 2020. Available from: https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-australian-therapeutic-goods-administrations [Last accessed: December 2021].
Deciphera Press Release: Deciphera Announces Health Canada’s Authorization of QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online]
June 22, 2020. Available from: https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-health-canadas-authorization-qinlocktm [Last accessed: December 2021].
Zai Lab Press Release: China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST) [online]
March 31, 2021. Available from: https://zailab.gcs-web.com/news-releases/news-release-details/china-nmpa-approves-qinlockr-ripretinib-treatment-advanced [Last accessed: December 2021].
Deciphera Press Release: Deciphera Receives European Commission Approval of QINLOCK® for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online]
November 22, 2021. Available from: https://investors.deciphera.com/news-releases/news-release-details/deciphera-receives-european-commission-approval-qinlockr [Last accessed: December 2021].
Zai Lab Press Release: QINLOCK® (Ripretinib) Approved in
Taiwanfor Treatment of Advanced Gastrointestinal Stromal Tumors (GIST) [online] September 1, 2021. Available from: https://zailab.gcs-web.com/news-releases/news-release-details/qinlockr-ripretinib-approved-taiwan-treatment-advanced [Last accessed: December 2021].
Deciphera Press Release: Deciphera Announces Approval of QINLOCK® in
Switzerlandfor the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] October 12, 2020. Available from: https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-approval-qinlockr-switzerland-treatment [Last accessed: December 2021].
Deciphera Press Release: FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online]
May 15, 2020. Available from: https://investors.deciphera.com/news-releases/news-release-details/fda-grants-full-approval-deciphera-pharmaceuticals-qinlocktm [Last accessed: December 2021].