Deciphera Presents Data from QINLOCK (Ripretinib) Program in Patients with Gastrointestinal Stromal Tumor at the European Society for Medical Oncology (ESMO) Virtual Congress 2020
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), today 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.
“As the body of data supporting QINLOCK’s efficacy and safety grows, we are pleased with QINLOCK’s ability to offer clinically meaningful benefit for GIST patients across multiple lines of therapy,” said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera. “Data presented today demonstrates impressive long-term, follow-up results from our INVICTUS study, which support QINLOCK’s efficacy in fourth-line GIST.”
INVICTUS Additional Nine Month Follow-up Data
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.