Verastem Stops Enrollment Due to Futility in the COMMAND Study of VS-6063 for the Treatment of Malignant Pleural Mesothelioma

On September 28, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported that the Company has stopped enrollment in the Phase 2 registration-directed, double-blind, placebo-controlled study (COMMAND) of VS-6063 for patients with mesothelioma (Press release, Verastem, SEP 28, 2015, View Source [SID:1234507592]). The decision to stop enrollment for futility followed a Data Safety Monitoring Board (DSMB) review of a pre-planned interim analysis. The results of the analysis demonstrated that VS-6063 had a generally well tolerated safety profile but that there was not a sufficient level of efficacy to warrant continuation of the study.

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"Malignant pleural mesothelioma is among the most aggressive and lethal cancers with only one approved therapy," said Lou Vaickus, MD FACP, Interim Chief Medical Officer. "With the aggressiveness of this disease, the use of single agent VS-6063 as a maintenance treatment following chemotherapy where all patients had residual disease was not sufficient. There remains a significant unmet medical need for new treatment options for patients suffering from this very complex, difficult-to-treat cancer."
"We have stopped further enrollment and initiated an orderly wind-down of the COMMAND study," said Robert Forrester, Verastem President and Chief Executive Officer. "We are disappointed with the COMMAND outcome, but we are deeply grateful for the support and commitment from the patients participating in the study, their families, and the study investigators. Based on these results, we will reevaluate our clinical priorities and direct our resources toward further development of VS-6063, VS-4718, and VS-5584."

As of the end of Q2 2015, Verastem had $132.1M in cash and cash equivalents.