Reduce cancer progression and risk of death by 85%! Positive clinical results in Phase 3 precision therapy
Last Update: 2020-06-17
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GIST is a sarcoma that appears in connective tissue in the bones or gastrointestinal tractTumors originate in cells in the gastrointestinal wall and are most common in the stomach and small intestineThere are about 4,000 to 6,000 new cases in the United States each year, most of them diagnosed between the ages of 50 and 80, and the incidence in Europe and other countries is roughly the same as in the United Statesmost GIST cases are due to clinically related genetic mutations that lead to increased activity of KIT or PDGFR alpha protein kinase, of which KIT kinase accounts for about 75% to 80% of cases and PDGFR alpha kinase accounts for 5% to 10% of casesSince existing therapies are mainly associated with protein kinase in inactivated conformation, some primary and secondary gene mutations can lead to resistance to existing therapies and disease progressionThe five-year survival rate of the disease is about 48 to 90 per cent, depending on the stage at which the disease is diagnosedRipretinib is a KIT or PDGFR alpha kinase inhibitor that is in clinical development for the treatment of KIT or PDGFR alpha-driven related cancers, including giST, systemic hypertrophy (SM) and other cancersRipretinib is specifically designed to improve the treatment of GIST patients by inhibiting broad-spectrum mutations in KIT or PDGFR alphaIn June 2019, the FDA granted ripretinib fast-track eligibility for the treatment of patients with advanced GIST who had previously received the treatment of imatinib, sunitinib, and regorafenibDeciphera has entered into an exclusive licensing partnership with Reding Pharmaceuticals to advance the development and promotion of ripretinib in Greater ChinaRipretinib Molecular Structure (Photo: PubChem)Phase 3 Clinical Trial INVICTUS is a randomized, double-blind, multi-center, placebo-controlled international study in which 129 patients were treated with ripretinib or placebo in a 2:1 ratio to assess the safety and efficacy of ripretinib for patients who had previously received imatinib, sunitinib, and reaibfentreatmentstudies showed that ripretinib reached the primary endpoint for improved progression-free survival (PFS), with 27.6 weeks of PFS in patients treated with ripretinib, compared with 4.1 weeks for the placebo group, and patients treated with ripretinib had an 85 percent lower risk of disease progression or death compared to placeboThe objective remission rate (ORR) for patients treated with ripretinib was 9.4%, compared with 0% for patients treated with a placeboThe total survival (OS) of patients treated with ripretinib was 15.1 months, while the OS was only 6.6 months in patients treated with a placebo, with significant clinical improvementin addition to incoming Phase 3 clinical trial sinvicTUS data, Deciphera will submit data from the ongoing Phase 1 clinical trial to support NDA, including the latest data from 178 patients with different types of GIST who received ripretinib treatmentthe latest data from the Phase 1 clinical trial of Ripretinib (Photo: Decipera's official website) from the above data, different types of GIST patients showed good ORR, disease control rate (DCR) and moderate progression-free survival (mPFS) after treatment with ripretinib "Today's announcement is an important milestone in our development of innovative cancer treatment," said Steve Hoerter, President and CEO of Deciphera THE INVICTUS RESEARCH DATA LEADS US TO BELIEVE THAT RIPRETINIB HAS A HIGH POTENTIAL TO CHANGE THE STATUS QUO OF GIST TREATMENT, AND OUR FOCUS NOW IS ON WORKING CLOSELY WITH THE FDA TO PROVIDE MUCH-NEEDED TREATMENT OPTIONS FOR PATIENTS WITH GIST WHO HAVE PREVIOUSLY BEEN TREATED BUT FAILED References: Deciphera Pharmaceuticals Announces Positive Top-Line Results from INVICTUS PivotAl Phase 3 Clinical Study of Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors Retrieved August 13, 2019, from Deciphera Pharmaceuticals Retrieved August 13, 2019, from
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