Deciphera Soars On Positive Readouts For Gastrointestinal Tumor Drug

Shares of thinly traded small-cap biotech Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) are skyrocketing Tuesday morning following a couple of clinical readouts from the company.

What Happened

Deciphera released updated data from a Phase 1 study of ripretinib, which continued to support the pipeline asset’s potential across the broad range of KIT and PDGR-alpha mutations that occur in patients with second-line through fourth-line gastrointestinal stromal tumors.

The updated included additional six months of maturity from the company’s last Phase 1 data cut-off.

“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,” said Steve Hoerter, CEO of Deciphera.

Separately, the biotech announced positive top-line data from the INVICTUS pivotal Phase 3 study of ripretinib in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors.

The study achieved the primary endpoint of improved progression free survival as determined by blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors version 1:1.

However, the pipeline compound did not meet the key secondary endpoint, as statistical significance was not achieved, with the objective response rate of 9.4% compared to 0% for the placebo. The overall survival, another secondary point, came in at 15.1 months for ripretinib versus 6.6% for placebo. It was also found to be generally well tolerated.

Why It’s Important

There is an unmet need for therapies that can effectively control gastrointestinal stromal tumors who have failed currently approved treatment options, Deciphera said.

Deciphera expects to submit an NDA to the FDA in the first quarter of 2020 for the treatment of patients with advanced gastrointestinal stromal tumors who have receive prior treatment with Imatinib, Sunitinib and Regorafenib.

The company also said it will submit in its NDA INVICTUS data and also the supportive data from the ongoing Phase 1 clinical study, which includes updated data from patients at doses of over 100mg of ripretinib.

“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,” the company said of the updated Phase 1 data.

Deciphera shares were soaring 121% to $44.12 at time of publication.

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