Synta Pharmaceuticals announced that the first patients have been treated in the randomized GALAXY-2 Phase 3 trial designed to evaluate docetaxel plus ganetespib, its investigational Hsp90 inhibitor, versus docetaxel alone for the second-line treatment of non-small cell lung adenocarcinoma. The study will enroll approximately 500 patients from about 140 cancer treatment centers worldwide. “The clinical results presented from the GALAXY-1 trial so far have been encouraging,” said Vojo Vukovic, M.D., Chief Medical Officer of Synta. The GALAXY program is based on a two-stage, operationally adaptive trial design, with the first Phase 2b/3 stage intended to identify the optimal patient population to be evaluated in a confirmatory Phase 3 trial. An interim analysis of adenocarcinoma patients in GALAXY-1 presented last September supported potential activity in the second-line treatment setting. The prespecified patient population in GALAXY-1 with a diagnosis of advanced disease more than six months prior to study entry, i.e., those patients who generally received a normal course of first-line chemotherapy before experiencing disease progression, was chosen for further evaluation in GALAXY-2. The primary endpoint of the GALAXY-2 trial is overall survival. Two event-driven interim analyses are planned, which will be reviewed by an independent data monitoring committee. Key secondary endpoints include progression-free survival and overall response rate, as well as overall survival in certain prespecified biomarker-defined subpopulations. Based on current projections, Synta expects the interim and final analyses of the GALAXY-2 trial to be conducted in 2014.
- Pharmaceuticals & Drug Trials