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Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced presentation of results from the GALAXY-1 trial, a global, randomized, multi-center Phase 2b/3 study designed to identify the patients with advanced non-small cell lung adenocarcinoma most likely to benefit from second-line treatment with the Company’s lead drug candidate, the Hsp90 inhibitor ganetespib. The results, from a planned interim analysis conducted in May, will be presented at the 2013 ECCO/ESMO/ESTRO conference and include a review of interim findings previously presented at ASCO 2013 as well as additional results for two of the study’s prespecified primary patient populations.
“We are encouraged by the improvements in PFS and OS in patients treated with ganetespib in the GALAXY-1 study,” said Dr. Vojo Vukovic, Chief Medical Officer, Synta. “We look forward to the GALAXY-1 final analysis, expected to be conducted later this year, and to results from GALAXY-2, expected in 2014.”
GALAXY program trial design
Drugs targeting the Hsp90 chaperone protein silence a broad network of cancer-promoting proteins, creating a wide range of potential biomarkers for selecting patients. The GALAXY-1 trial was designed to enroll a substantially larger number of patients than conventional Phase 2b trials, in order to allow sufficient statistical power to detect signals in one or more patient populations identified by Hsp90-related clinical markers.
Patients with non-small cell lung adenocarcinoma who had received one prior regimen for advanced disease were randomized 1:1 to treatment with either ganetespib plus docetaxel or docetaxel alone. Key patient populations evaluated include:
Patients with elevated LDH. LDH-A is a marker of HIF-1alpha activity, a strong Hsp90 client and a key driver of tumor invasiveness and metastasis. Ganetespib has been shown to inhibit HIF-1alpha in tumors in both preclinical models of cancer and in translational studies in patients.
Patients with elevated LDH have poor prognosis and limited treatment options, representing a population with high unmet medical need.