Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced presentation of results from the GALAXY-1 trial, a global, randomized, multi-center 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, in combination with docetaxel versus docetaxel alone. The results will be presented Monday, October 28 2013, at 10:30 AM local time during an oral session at the 15 th World Conference on Lung Cancer (WCLC) in Sydney, Australia.
Ganetespib is a second-generation inhibitor of the chaperone protein Hsp90, which is critical for the activation and stability of numerous proteins that drive cancer growth and proliferation. Ganetespib has been studied in over 25 clinical trials and 800 patients to date. In these trials, ganetespib has shown durable objective responses, including CRs (complete responses) and near-CRs, when used alone, as monotherapy administration, in patients with several different types of late-stage cancer, as well as a favorable safety profile, with no evidence of the serious liver or common ocular toxicities seen with other Hsp90 inhibitors.
“Our strategy with the GALAXY lung cancer program has been to use a large, global Phase 2b trial to increase the probability of a positive outcome in Phase 3,” said Dr. Safi R. Bahcall, President and CEO, Synta. “We designed the GALAXY-1 trial, which enrolled close to 400 patients in total, to address two primary questions: (1) how to optimize patient selection for Phase 3 and (2) how to reduce the operational risks from heterogeneous populations and treatment patterns that often confound large, pivotal studies. The one-year follow-up results from GALAXY-1 address both these questions, confirming our choices for patient selection and increasing our confidence in a positive outcome for the ongoing GALAXY-2 trial.”
“'As the data become more mature, the improvements in progression-free survival and overall survival with ganetespib and docetaxel in the patient subpopulation selected for Phase 3 study are very encouraging,” said Dr. Suresh Ramalingam, M.D., Professor, Hematology & Medical Oncology, and Director, Division of Medical Oncology, of the Winship Cancer Institute of Emory University, and a principal investigator of the GALAXY program. “These results bode well for the mirror image GALAXY-2 trial.”