Drug manufacturer Verastem, Inc., has initiated a registration-directed, double-blind, placebo-controlled clinical trial for patients with malignant pleural mesothelioma. The trial is a registration-directed trial for VS-6063, Verastem’s lead cancer stem cell inhibitor defactinib , and will target killing cancer stem cells. The clinical trial is called Control of Mesothelioma with MAiNtenance Defactinib, or COMMAND.
Mesothelioma is a rare and deadly form of cancer linked to asbestos exposure. It typically affects the lining of the lungs or abdomen, but may also rarely affect the lining of the heart. Malignant pleural mesothelioma affects the lining of the lungs. There is currently no known cure for mesothelioma.
Primary endpoints of the COMMAND trial are Progression Free Survival (PFS) and Overall Survival (OS). The study is based on pre-clinical research that indicates cancer stem cell inhibitors may be effective in treating mesothelioma patients whose tumors are low in the biomarker merlin. The COMMAND trial will include both general population mesothelioma patients and patients who have low merlin biomarkers.
The clinical trial is expected to include between 350-400 patients at clinical facilities in 11 countries, including the United States, UK, Australia, Canada, South Africa, New Zealand and in mainland Europe.
Professor Dean Fennell is Coordinating Investigator for the COMMAN trial in the UK. He tells the Wall Street Journal, “The incidence of mesothelioma, among the most aggressive and lethal cancers, is increasing worldwide, underscoring an urgent need to expand the very limited treatment options for patients fighting this disease.” Fennell also serves as Chair of Thoracic Medical Oncology at the University of Leicester, and is incoming President of the International Mesothelioma Interest Group (iMig). “There is significant enthusiasm within the mesothelioma community for the COMMAND study,” he told WSJ.
According to its website, “Verastem, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is developing small molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation: FAK, PI3K/mTOR and Wnt.”
The U.S. Food and Drug Administration’s (FDA) Office of Orphan Drug Products recently granted Verastem orphan drug designation for defactinib in mesothelioma. The company received a similar designation from the European Commission in June.