Deciphera Pharmaceuticals DCPH Stock News

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) is rocketing in the market this morning, trading on gains of well over 100%. The gains come after the company announced positive updates from a Phase 1 and a Phase 3 clinical study. Here’s what’s going on:

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DCPH Stock Rockets On Positive Clinical Data

In a press release issued early this morning, Deciphera Pharmaceuticals provided an update with regard to its ongoing clinical study of ripretinib. The Phase 1 study is assessing the broad-spectrum KIT and PDGFRa inhibitor, in patients with second-line through fourth-line plus gastrointestinal stromal tumors, or GIST.

The release came shortly after the first press release issued by the company this morning, announcing the results of a late-stage clinical study in stomach cancer. In the first release, the company announced data from a Phase 3 study of ripretinib in fourth line and fourth line plus stomach cancer patients.

The study, dubbed INVICTUS, is  Phase 3, randomized, double blind, placebo controlled, international, study assessing the safety, tolerability, and efficacy of ripretinib when compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib.

In the release, DCPH said that the Phase 3 study met its primary endpoint by improving progression free survival as determined by blinded independent central radiologic review. Median progression free survival in the treatment arm of the study was 6.3 months. This compared well to just 1 month in the placebo arm.

Also, the company said that the treatment led to an 85% reduction of disease progression or death when compared to placebo. Moreover, all secondary endpoints were met. Finally, DCPH said that the treatment showed to be generally well tolerated with adverse events results consistent with data from previously presented Phase 1 study results.

In a statement, Margaret von Mehren, MD from the Department of Medical Oncology at the Fox Chase Cancer Center, had the following to offer with regard to the data:

There is a dire unmet need for new therapies that can deliver effective disease control for patients with advanced GIST who have failed currently approved treatment options. 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.

The above statement was followed by Steve Hoerter, President and CEO at DCPH. Here’s what he had to say:

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.

This News Is Significant

The news released by Deciphera Pharmaceuticals today proved to be overwhelmingly positive. Not only did patients in the advanced stomach cancer Phase 3 trial respond well, the Phase 2 trial in patients with second through fourth line plus stomach cancer is progressing smoothly.

Considering the fact that the Phase 3 trial results were positive, the company is likely setting up for a New Drug Application submission to the FDA relatively soon. This is a big deal considering that the gastric cancer market is expected to grow to be worth $4.4 billion annually by 2024.

With a market cap around $700 million, DCPH stands to see incredible value growth, should it tap into such a large market.

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