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SYMMETRY halted early; elesclomol/paclitaxel fails to increase PFS for metastatic melanoma
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Elesclomol, an investigational oxidative stress inducer, in combination with paclitaxel was not associated with a clinically significant improvement in PFS in chemotherapy-naive patients with stage IV metastatic melanoma, according to data from the phase-3 SYMMETRY trial. In addition, fewer deaths in the paclitaxel alone arm caused the trial to close early.
“On February 23, 2009 after all patients had been accrued to the study, a data monitoring committee conducted an ad-hoc interim analysis and recommended the unblinding of the study,” said Steven J. O’Day, MD, chief of research and director of the melanoma program at The Angeles Clinic and Research Institute. “The data analysis indicated that the primary endpoint PFS would not be met and early OS analysis indicated that there was an unexplained imbalance in death favoring control arms at 80 vs. 53 deaths.”
O’Day presented the preliminary data at the 2009 ASCO Annual Meeting.
Between September 2007 and February 2009 researchers randomly assigned 651 patients with stage IV metastatic melanoma to 213 mg/m2 elesclomol plus 80 mg/m2 paclitaxel (ELPAC) or 80 mg/m2 paclitaxel alone. Both arms were given weekly for three weeks followed by one week of rest until disease progression. The primary endpoint was PFS, which was based on 219 PFS events.
Median PFS was 3.5 months in the ELPAC arm compared with 1.9 months in the paclitaxel arm (HR=0.88; 95% CI, 2.7-3.7). The median number of ELPAC cycles was three compared with two cycles of paclitaxel.
"Despite a trend in improvement in PFS, elesclomol in combination with paclitaxel failed to demonstrate a statistically significant improvement when compared with paclitaxel alone in chemo-naive patients with metastatic melanoma," O'Day said.
There were no statistically significant differences between adverse events, grade-3 adverse events, serious adverse events, or adverse events leading to discontinuation. There was a slight difference in adverse events leading to death in the combination arm (19 vs. 6). However, O'Day said that the data has been looked at carefully and no common organ toxicity was discovered. A large number of these cases died of progressive disease.
“To date, no organ-specific toxicities have been identified that explain the observed imbalance in deaths and safety data is continuing to be evaluated. At this point, overall survival data is continuing to mature and more mature data will be presented at future scientific meetings.” – by Stacey L. Adams
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