Deciphera Pharmaceuticals, Inc. (DCPH - Free Report) announced encouraging data from a pivotal phase III study — INVICTUS — evaluating its pipeline candidate, ripretinib, in patients with gastrointestinal stromal tumors (“GIST”) in fourth or later-line setting. Data from the study demonstrated that treatment with ripretinib led to significant reduction in the risk of disease progression or death.
On the back of this encouraging data, the company announced that it will file a new drug application in the first quarter of 2020, seeking approval of ripretinib in a similar indication.
Shares of Deciphera skyrocketed almost 80% on Aug 13, following the study data announcement. In fact, the company’s shares have rallied 71% so far this year against the industry’s decline of 2.1%.
The INVICTUS study evaluated KIT and PDGFRα inhibitor, ripretinib, in GIST patients previously treated with at least Novartis’ (NVS - Free Report) Gleevec (imatinib), Pfizer’s (PFE - Free Report) Sutent (sunitinib) and Bayer’s (BAYRY - Free Report) Stivagra (regorafenib).
Data from the study showed ripretinib met the primary endpoint of progression-free-survival (“PFS”). The median progression-free-survival or PFS was 6.3 months for ripretinib, significantly higher than 1 month for placebo or 85% reduction in risk of disease progression or death. Median overall survival was 15.1 months for ripretinib versus 6.6 months for placebo. Although ripretinib improved objective response rate or ORR (9.4%), it was not statistically significant compared to placebo (ORR 0%).
In a separate press release, Deciphera announced updated data from a phase I study evaluating ripretinib in GIST patients in second, third or fourth-line settings. Data showed that treatment with ripretinib led to median PFS of 42 weeks, 40 weeks and 30 weeks, and achieved ORR of 30%, 23% and 15% in second-, third- and fourth-line setting, respectively. Updated data demonstrates that median PFS was sustained across all arms of the study. Moreover, the data supports ongoing phase III study — INTRIGUE — evaluating ripretinib in second-line GIST.
Deciphera currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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