Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that the results from an interim survival analysis of the GALAXY-1 trial will be presented at this year’s Best of ASCO Meetings in Chicago, Los Angeles, and Boston. GALAXY-1 is a global, randomized Phase 2b/3 study designed to evaluate the efficacy and safety of the Company’s lead drug candidate, ganetespib, as second-line treatment for patients with advanced non-small cell lung adenocarcinoma.
The recent interim analysis for overall survival in GALAXY-1 was first presented on June 3 during an oral session at the 2013 ASCO Annual Meeting in Chicago by Dr. Suresh Ramalingam, M.D., Professor, Hematology & Medical Oncology, and Director, Division of Medical Oncology, of the Winship Cancer Institute of Emory University. Results showed the combination of ganetespib and docetaxel improved overall survival and progression-free survival compared to docetaxel alone, and confirmed earlier findings of enhanced clinical activity in the prospectively specified patient population selected last year for further evaluation in the GALAXY-2 Phase 3 trial. GALAXY-2 is currently enrolling patients, with results expected in 2014.
The GALAXY-1 results will be presented during the “Non-small Cell Metastatic Lung Cancer” sessions taking place at:
Best of ASCO ChicagoAugust 10, 2013, 10:00 – 11:00 AM CDTBest of ASCO Los AngelesAugust 17, 2013, 10:00 – 11:00 AM PDT Best of ASCO BostonAugust 24, 2013, 10:00 – 11:00 AM EDT Slides discussing the GALAXY-1 results presented at ASCO are available on the Company’s website at www.syntapharma.com. About Ganetespib Ganetespib, an investigational drug candidate, is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone which controls the folding and activation of a number of client proteins that drive tumor development and progression. Many solid and hematologic tumors are dependent on Hsp90 client proteins including proteins involved in “oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen receptor, estrogen receptor, JAK2); proteins involved in resistance to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1, survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha, VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF, AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of Hsp90 by ganetespib results in the inactivation, destabilization, and eventual degradation of these cancer-promoting proteins. Ganetespib is being evaluated in trials in lung cancer, breast cancer, and other tumor types. The most common adverse event seen to date has been transient, mild or moderate diarrhea, which has been manageable with standard supportive care. Information on these trials can be found at www.clinicaltrials.gov. About the GALAXY Program The GALAXY (Ganetespib Assessment in Lung cAncer with docetaXel) program consists of two randomized trials comparing the combination of ganetespib and docetaxel versus docetaxel alone in patients with Stage IIIB/IV NSCLC who have received one prior systemic therapy: a 300-patient Phase 2b/3 trial (GALAXY-1) to determine the patient population most likely to derive benefit from ganetespib, and a 500-patient confirmatory Phase 3 trial (GALAXY-2). More information about the GALAXY trials can be found at www.clinicaltrials.gov (NCT01348126 and NCT01798485). About Lung Cancer Lung cancer is the leading cause of cancer-related death in the world, accounting for nearly 1.4 million deaths in 2008, according to the World Health Organization. The five-year survival rate for this disease is approximately 16%; over half of people with lung cancer die within one year of being diagnosed. In the U.S., the American Cancer Society estimates that 228,000 cases of lung cancer will be diagnosed in 2013. Non-small cell adenocarcinoma comprises about 40% of all lung cancer.