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news.Synta Pharmaceuticals, a biopharmaceutical company, has announced 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.
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The decision to suspend the Symmetry trial was based on the results of an analysis by the independent Data Monitoring Committee (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 announced that additional ongoing studies with elesclomol, including a study of elesclomol 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. Synta is contacting investigators regarding appropriate patient notification and care.
Eric Jacobson, chief medical officer of Synta, said: “Our first concern is for the safety of patients, and therefore we acted promptly to halt the Symmetry trial once it was evident that there were serious safety concerns. We are enormously disappointed for melanoma patients, particularly because there are so few treatment options available. We will be working hard over the next several weeks to analyze and better understand the results from this trial.”