Synta presents ganetespib Phase 1, 2 trial results against solid tumors at ASCO 2011
April 21, 2016
"Few therapeutic options are available to patients with advanced gastrointestinal tumors following treatment with the standard of care tyrosine-kinase inhibitor drugs, imatinib and sunitinib. Ganetespib showed activity in approximately half of GIST patients evaluated with PET imaging in this Phase 2 trial, including a 20% decrease in tumor metabolic activity," said George Demetri, M.D., Principal Investigator of the trial from the Dana-Farber Cancer Institute. "Analysis of tumor biopsies and PET imaging data suggest that optimizing the administration schedule of ganetespib could potentially increase KIT suppression and improve the clinical activity of ganetespib in GIST patients. Ganetespib was well-tolerated in this patient population, with the most common adverse events being Grade 1 and 2 diarrhea which was generally manageable with supportive care."
At the time of the analysis, 23 patients out of 26 patients in the intent to treat (ITT) population were evaluable. Patients enrolled in the ITT population had experienced a median of five prior treatments.
58% of patients (7 of 12 patients evaluated) reported a greater than 20% decrease in Standardized Uptake Value (SUV) as measured by positron emission tomography (PET) imaging. 22% of evaluable patients experienced a clinical benefit at 16 weeks (Partial Response + Complete Response + Stable Disease). There were no objective responses. One patient was non-evaluable.
The most common adverse events reported in more than 5% of patients were blood alkaline phosphatase increase (11.5%), anaemia (7.7%), and diarrhea (7.7%). The most frequent reported adverse events occurring in more than 40% of patients were diarrhea (84.6%), fatigue (53.8%) and nausea (46.2%).
Source: Synta Pharmaceuticals Corp.