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Merck and Syndax partner for cancer combo clinical

Posted on 01 April 2015

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Syndax and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining entinostat, an investigational epigenetic therapy, with KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States.

The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma.

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The study is expected to begin enrolling patients in the second half of 2015.

The financial terms and additional details of the agreement between Syndax and Merck, through a subsidiary, were not disclosed.

The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial.

The planned Phase 1b/2 multicenter, open-label clinical trial will be conducted in two parts.

The Phase 1b portion is designed to determine the safety and tolerability of entinostat in combination with KEYTRUDA.

The Phase 2 portion is designed to evaluate the efficacy of entinostat combined with KEYTRUDA in patients with advanced NSCLC and melanoma.

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