Thinly traded Deciphera Pharmaceuticals (NASDAQ:DCPH) is up 101% premarket on increased volume in reaction to positive topline results from a 129-subject Phase 3 clinical trial, INVICTUS, evaluating ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST).
The study met the primary endpoint of demonstrating a statistically significant improvement in progression-free survival (PFS) compared to placebo. Specifically, median PFS in the treatment arm was 6.3 months versus 1.0 month in the control arm with an 85% reduction in the risk of cancer progression or death (hazard ratio = 0.15).
The objective response rate (ORR), a key secondary endpoint, also showed ripretinib's superiority, 9.4% vs. 0.0%, although the separation was just shy of statistical significance (p=0.0504). Median overall survival favored ripretinib, 15.1 months vs. 6.6 months.
No new safety signals were reported. 99% (n=84/85) of the ripretinib cohort experienced a treatment-emergent adverse event. The most common where alopecia (hair loss) (52%), fatigue (42%), nausea (39%), abdominal pain (36%) and constipation (34%).
49% (n=42/85) experienced serious or life-threatening treatment-related adverse events versus 44% (n=19/44) for placebo. The most common were anemia (n=8), abdominal pain (n=6) and hypertension (n=6).
Additional data will be submitted for presentation at a future medical conference.
The company plans to file a U.S. marketing application in Q1 2020 for patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
https://seekingalpha.com/news/3491015-deciphera-101-percent-premarket-positive-late-stage-ripretinib-data
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