Verastem stops enrolment in trial of VS-6063 in mesothelioma
Posted: 28 September 2015 |
While VS-6063 had a generally well tolerated safety profile, there was not a sufficient level of efficacy to warrant continuation of the study…
Verastem today announced that it has stopped enrolment in the Phase 2 registration-directed, double-blind, placebo-controlled study (COMMAND) of VS-6063 for patients with mesothelioma.
The decision to stop enrolment 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.
The use of VS-6063 as a maintenance treatment following chemotherapy was “not sufficient”
“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 enrolment 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 re-evaluate our clinical priorities and direct our resources toward further development of VS-6063, VS-4718, and VS-5584.”