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Deciphera Plans Ripretinib NDA Filing For Q1 2020 On Phase III GIST Data

 
• By Mandy Jackson

CEO Steve Hoerter sees best-in-class potential for the drug based on both efficacy and safety in the fourth-line gastrointestinal stromal tumor setting, with the INVICTUS trial having positive readthrough to the ongoing Phase III INTRIGUE study in second-line GIST.

Microscopic image of a gastrointestinal stromal tumor (GIST). Malignant potential depends on size, location and mitotic activity. Targeted therapy with Imatinib (Gleevec) may prevent recurrence. - Image
Deciphera's ripretinib targets GIST cells with KIT and PDGFRa mutations. • Source: Shutterstock

Deciphera Pharmaceuticals Inc.'s ripretinib met and potentially exceeded expectations in the placebo-controlled Phase III INVICTUS clinical trial testing the KIT and PDGFRa kinase switch control inhibitor in fourth-line treatment of gastrointestinal stromal tumors (GIST), justifying the filing of a new drug application (NDA) with the US Food and Drug Administration in the first quarter of 2020.

The company reported median progression-free survival (mPFS) in INVICTUS – the trial's primary endpoint – of 6.3 months (27.6 weeks) for ripretinib-treated patients versus one month (4.1 weeks) in the placebo group (HR=0.15; p<0.0001) on 13 August

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