공시 • Sep 19
Deciphera Pharmaceuticals, Inc. Presents Data from QINLOCK™ (Ripretinib) Program in Patients with Gastrointestinal Stromal Tumor at the European Society for Medical Oncology Virtual Congress 2020
Deciphera Pharmaceuticals, Inc. announced the presentation of nine month follow-up data from the Company’s Phase 3 INVICTUS study of QINLOCK in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) and intra-patient dose escalation data from the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST. The mini-oral presentations, titled “Clinical Benefit with Ripretinib as =4th Line Treatment in Patients with Advanced Gastrointestinal Stromal Tumors (GIST): Update from the Phase 3 INVICTUS Study” and “Ripretinib Intra-patient Dose Escalation (IPDE) Following Disease Progression Provides Clinically Meaningful Progression-Free Survival (PFS) in Gastrointestinal Stromal Tumor (GIST) in Phase 1 Study”, were featured at the ESMO Virtual Congress 2020 being held September 19-21, 2020. The INVICTUS Phase 3 clinical study is a randomized (2:1), double-blind, placebo-controlled, international, multicenter study to evaluate the safety, tolerability, and efficacy of QINLOCK compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib. The Company previously reported results from the randomized portion of the INVICTUS study, in which QINLOCK significantly improved progression-free survival (PFS) and showed a clinically meaningful overall survival (OS) benefit. As of a March 9, 2020 cutoff date, approximately nine months from the data cutoff date for the primary analysis, QINLOCK continues to provide clinically meaningful benefit with a well-tolerated safety profile in patients with advanced GIST who have received at least three prior tyrosine kinase inhibitors. The median PFS, as measured by blinded independent central review, remained at 6.3 months versus 1.0 month in the placebo arm. The hazard ratio (HR) was 0.16. The median OS as of the data cutoff was not reached in the QINLOCK arm versus 6.3 months in the placebo arm with a HR of 0.42, as compared to the median OS at the May 2019 data cutoff for the primary analysis of 15.1 months in the QINLOCK arm versus 6.6 months in the placebo arm with a HR of 0.36. QINLOCK also demonstrated a confirmed objective response rate of 11.8% versus 0% in the placebo arm compared to rates of 9.4% versus 0% in the placebo arm as of the data cutoff date for the primary analysis. Safety findings were consistent with the previous primary analysis results, demonstrating that QINLOCK was generally well tolerated. In the ongoing Phase 1 study of QINLOCK in patients with second-line through fourth-line plus GIST, patients were permitted to dose escalate to QINLOCK 150 mg twice-daily, or BID, after disease progression on QINLOCK 150 mg once-daily, or QD. The presentation highlighted that the patients in second-, third- or fourth-line plus GIST who dose escalated to QINLOCK 150 mg BID experienced additional clinically meaningful benefit. Comparison of TEAEs reported in the QINLOCK 150 mg QD and 150 mg BID periods demonstrated that QINLOCK was similarly well-tolerated. 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 mutation involved in systemic mastocytosis, or SM. QINLOCK also inhibits primary PDGFRa mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST. QINLOCK 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 and 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. Deciphera Pharmaceuticals is developing QINLOCK for the treatment of KIT and/or PDGFRa-driven cancers, including GIST, SM, and other cancers. Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co. Ltd. for the development and commercialization of QINLOCK in Greater China (MainlandChina, Hong Kong, Macau, and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for QINLOCK in the rest of the world.