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Trial of elesclomol/paclitaxel in melanoma terminated
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A phase 3 trial designed to investigate paclitaxel with or without elesclomol was terminated due to an imbalance of mortality and a failure to reach a predetermined PFS endpoint.
Elesclomol may have a number of positive effects on advanced melanoma, including inducing oxidative stress and triggering mitochondrial-induced apoptosis in cancer cells, according to researchers. The drug also shows synergy with taxanes in tumor models, according to their findings.
Phase 2 results for the drug yielded encouraging outcomes in PFS. The randomized, double blind, controlled phase 3 study built on efficacy and tolerability profiles of elesclomol with paclitaxel or paclitaxel alone.
The analysis included 651 patients with stage IV chemotherapy-naive melanoma.
The regimens were paclitaxel 80 mg/m2 alone or with elesclomol 213 mg/m2 administered weekly for 3 weeks of a 4-week cycle.
The study failed to reach the PFS endpoint (HR=0.89; P=.23). Researchers terminated the trial when preliminary OS data indicated an imbalance of mortality favoring paclitaxel. These deaths were seen primarily in patients with high LDH levels.
A statistically significant improvement in median PFS was observed for the combination therapy in patients with normal baseline LDH.
“The association between baseline LDH and clinical outcomes suggests that LDH may be a predictive factor for treatment with this combination, consistent with recent findings on the association between elesclomol anticancer activity and cellular metabolic state,” the researchers concluded.
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