Deciphera Pharmaceuticals Inc. (NASDAQ: DCPH) shares nearly doubled on Tuesday after the firm announced top-line results from its late-stage trial treating patients with gastrointestinal stromal tumors (GIST). Specifically, this data came from the Invictus pivotal Phase 3 clinical study of ripretinib.

In the study, ripretinib demonstrated a median progression free survival (PFS) of 6.3 months, compared to 1.0 month in the placebo arm, and significantly reduced the risk of disease progression or death by 85% compared to placebo.

For the key secondary endpoint, ripretinib demonstrated an objective response rate of 9.4% compared with 0% for placebo, which was not statistically significant. Ripretinib in this study also showed a clinically meaningful improvement over placebo in terms of the secondary endpoint overall survival.

As a result, management is turning its focus now to working closely with the U.S. Food and Drug Administration (FDA) as it evaluates ripretinib for those patients with GIST who, having failed all currently approved therapies, are in desperate need of a treatment option.

The company expects to submit a New Drug Application (NDA) to the FDA in the first quarter of 2020.

Margaret von Mehren, M.D., Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, commented:

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.

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. On behalf of the entire Deciphera team, I would like to thank the patients, their caregivers and the healthcare professionals who participated in the INVICTUS study. The data from INVICTUS reinforce 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.

Shares of Deciphera Pharmaceuticals traded up about 97% to $39.25 Tuesday morning, in a new 52-week range of $18.55 to $42.99. The consensus price target is $45.50.

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