Deciphera Pharmaceuticals recently announced the initiation of a Phase 3 clinical study. The study aims to investigate the safety and effectiveness of a new drug targeting gastrointestinal stromal tumors.
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Deciphera differs from other pharmaceutical companies by specifically focusing on drug resistant cancers. In their statements, Deciphera explains that their work largely focuses on small molecule drug candidates. The pharmaceutical company targets kinases with much of their research since those enzymes are highly involved in the growth of a large number of cancers.
The new drug therapy, labeled DCC-2618, targets gastrointestinal stromal tumors (GIST), and will go forward in the company’s phase 3 INVICTUS study.
“We are extremely pleased to initiate the INVICTUS study with DCC-2618 in heavily pretreated GIST patients, specifically fourth-line, and fourth-line plus patients,” said Deciphera’s president and CEO, Michael D. Taylor, Ph.D.
Taylor speaks with confidence about the study. He anticipates that his company will post “top-line results in 2019.” If the study proves successful, it may lead to a New Drug Application for DCC-2618.
This would provide a treatment for patients who currently have no options.
Deciphera also hopes to launch another Phase 3 clinical study later in the year. This study would evaluate the use of DCC-2618 in second-line GIST patients who have not found success with another form of therapy.
Effective treatment currently exist for early stages of GIST. Nine out of 10 patients, however, will inevitably progress to a more advanced stage of the disease. This is largely the result of drug resistant mutations. The innovation of a therapy which can cover the entire spectrum of mutations has been described as a well needed improvement.
The INVICTUS Phase 3 clinical study will be thorough. The study will be randomized, double-blind, placebo-controlled, and international, at multiple centers. Safety, and tolerability are primary areas of interest for the study. Efficacy will also be tested by comparison to the placebo. GIST patients in the study will have already experienced treatment with drugs such as imatinib, sunittinib, and regorafenib. 120 patients are expected to make up the study group.
DCC-2618 is designed to target a specific type of of cancer. It is described as a pan-KIT, and PDGFRa kinase switch control inhibitor. Gastrointestinal stromal tumors, glioblastoma multiforme, and systemic mastocytosis are all cancers DCC-2618 is designed to be especially effective against. DCC-2618 aims to improve GIST treatment by preventing a wide variety of possible mutations.
Success in this study could lead to the only approved treatment option for advanced and pretreated GIST patients.
More information about Deciphera’s Phase 3 Trial can be found at clinicaltrials.gov using the search code NCT03353753.