On September 5, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that data from the Company’s INVICTUS pivotal Phase 3 study of ripretinib in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) has been selected as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress to be held September 27 – October 1, in Barcelona, Spain (Press release, Deciphera Pharmaceuticals, SEP 5, 2019, View Source [SID1234539302]).
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"We look forward to the first presentation of the INVICTUS Phase 3 data in an oral session at ESMO (Free ESMO Whitepaper) later this month," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The INVICTUS data have given us confidence that ripretinib has the potential to fundamentally transform the treatment paradigm for patients with advanced GIST who have no approved treatment options. We expect that these data will serve as the basis for our first NDA, which we plan to submit in the first quarter of 2020."
Presentation information is as follows:
Session Type: Late-Breaking Abstract, Proffered Paper Session
Session Title: Proffered Paper – Sarcoma (ID 249)
Title: INVICTUS: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ripretinib as ≥4th-Line Therapy In Patients With AdvanCed Gastrointestinal Stromal TUmorS (GIST) Who have Received Treatment With Prior Anticancer Therapies (NCT03353753) (ID 4794)
Presentation Number: LBA87
Date and Time: Monday, September 30, 2:45 – 2:57 PM CET
Location:Malaga Auditorium (Hall 5)
Speaker: Margaret von Mehren, MD, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania
About Ripretinib
Ripretinib is an investigational KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary D816V exon 17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (MainlandChina, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.