Synta suspends SYMMETRY trial

Massachusetts, USA-based Synta Pharmaceuticals says that, based on an  analysis by an independent Data Monitoring Committee, it has suspended  the SYMMETRY trial, the Phase III clinical study comparing elesclomol in  combination with paclitaxel to paclitaxel alone in chemo-naive patients  with stage IV metastatic melanoma. The decision to suspend the trial was  based on the results of an analysis by the DMC, which identified safety  concerns, including an imbalance in overall survival, with a greater  number of deaths occurring in the combination arm (elesclomol with  paclitaxel) compared to the control arm (paclitaxel alone). The final  analysis of the primary endpoint as assessed by independent reviewers  has not been carried out yet.

Based on these findings, Synta also said that additional ongoing studies  with elesclomol, including one in combination with docetaxel in  hormone-refractory metastatic prostate cancer and a monotherapy dose  escalation study, will be suspended pending further analysis of the  results of the SYMMETRY trial.