Early this morning, clinical-stage biopharmaceutical company Deciphera Pharmaceuticals Inc. (DCPH:NASDAQ) focused on addressing key mechanisms of tumor drug resistance, announced positive top-line results from the INVICTUS Pivotal Phase 3 Clinical Study of ripretinib in patients with advanced gastrointestinal stromal tumors. Investors reacted very positively to the news by piling into the stock, sending the firm's shares 115% higher at the market open over the prior day's closing price on extraordinarily high trading volume.
The company explains in the release that ripretinib is a broad-spectrum KIT and PDGFRα inhibitor, for patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST). 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 ripretinib compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib and regorafenib.
The key findings of the study were outlined as follows: INVICTUS achieved primary endpoint, Ripretinib significantly improved progression free survival (PFS) versus placebo in patients with fourth-line and fourth-line plus GIST, median PFS for Ripretinib of 6.3 months versus placebo of 1.0 month; hazard ratio of 0.15, p<0.0001; and that the company expects to submit a New Drug Application (NDA) to the FDA in Q1/20 for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
Regarding the study, Margaret von Mehren, MD, in the Department of Medical Oncology of the Fox Chase Cancer Center in Philadelphia, commented, "These top-line data from a Phase 3, randomized, placebo-controlled study are highly impressive and suggest that ripretinib's approach of targeting the broad spectrum of KIT and PDGFRα mutations known to drive GIST can significantly improve progression free survival in the most heavily pretreated patients. Particularly notable is the magnitude of benefit observed for overall survival in this study."
Steve Hoerter, president and CEO of Deciphera added, "Today's announcement represents a significant milestone in our mission to deliver important new medicines for the treatment of cancer...The data from INVICTUS reinforces our belief that ripretinib has the potential to transform the treatment of GIST, and our focus now turns to working closely with the FDA as they evaluate ripretinib for those patients with GIST who, having failed all currently approved therapies, are in desperate need of a treatment option."
Based on the positive INVICTUS data, the company expects to submit an NDA to the FDA in Q1/20 for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib. In 2019, the FDA already granted fast track designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
In addition to the Phase 3 study mentioned above, the company also issued a second release reporting positive updated Phase 1 data for Ripretinib in gastrointestinal stromal tumors, adding that the data from the Phase 1 study supports the ongoing INTRIGUE Phase 3 clinical study in patients with second-line GIST, and median progression free survival (mPFS) sustained across all cohorts.
Regarding the updated Phase 1 results, Mr. Steve Hoerter, president and CEO of Deciphera noted, "We believe the updated data from our ongoing Phase 1 clinical study, with the additional six months of maturity from our last Phase 1 data cut-off, continue to support ripretinib's potential across the broad range of KIT and PDGFRα mutations known to occur in patients with GIST following therapy with imatinib...In the updated data from the second-line cohort, we believe ripretinib has demonstrated encouraging clinical benefit based on the objective response rate, disease control rate and median progression free survival rates observed. These results strengthen our confidence in the INTRIGUE pivotal Phase 3 clinical study comparing ripretinib to sunitinib, the standard of care for patients receiving second-line treatment for GIST."
Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the U.S. and a similar incidence rate in European and other countries. Estimates for five-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.
Deciphera Pharmaceuticals indicates that it is a clinical-stage biopharmaceutical company developing new drugs to "improve the lives of cancer patients by addressing key mechanisms of drug resistance that limit the rate and durability of response of many cancer therapies." Its targeted, small molecule drug candidates, designed using its proprietary kinase switch control inhibitor platform, inhibit the activation of kinases, an important family of enzymes, that when mutated or over expressed, are known to be directly involved in the growth and spread of many cancers. The firms is studying its lead drug candidate, ripretinib (DCC-2618) in two ongoing Phase 3 studies in gastrointestinal stromal tumors, or GIST, and in an ongoing Phase 1 trial in patients with multiple advanced malignancies, including GIST.
Deciphera shares opened up 115% higher today at $42.90 (+$22.95, +115.03%) compared to yesterday's closing price of $19.95. Since the open the stock has traded between $34.55-42.99/share on more than 25 times average volume setting a 52-week intraday high price. At present, shares are trading at $35.72 (+$15.77, +79.05%).[NLINSERT]
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