Verastem, focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, has announced the expansion of its ongoing COMMAND study to include clinical trial sites in Japan. COMMAND is a registration-directed trial evaluating the company’s lead candidate targeting cancer stem cells, VS-6063 (defactinib) a potent inhibitor of focal adhesion kinase (FAK), in patients with malignant pleural mesothelioma. Mesothelioma is a highly aggressive form of lung cancer and a high percentage of cases contain cancer stem cells. With the inclusion of Japan, COMMAND is now accruing patients and pursuing parallel clinical development in the major markets worldwide.

“The incidence of mesothelioma, among the most aggressive and lethal cancers, is rapidly increasing in Japan and the survival rate for these patients is extremely poor,” said Professor Takashi Nakano, managing director, chief professor and chairman, Department of Thoracic Oncology, Hyogo College of Medicine. ”New treatment options for patients with mesothelioma are urgently needed.”

“Typically the Japanese development of novel oncology agents is delayed compared to the rest of the world,” said Professor Kazuhiko Nakagawa, managing director, professor, department of medical oncology, Kinki University Faculty of Medicine. “We were able to initiate and complete the Phase 1 assessment of VS-6063 in less than a year. By completing the trial so quickly, the ongoing COMMAND study can now include Japanese clinical sites in parallel with the other major countries participating in the trial.”

Verastem recently reported the successful outcome of its Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumours. The study results demonstrated that VS-6063 was well tolerated at all three dose levels tested. The data were consistent with the results from the US Phase 1 trial and there were no serious adverse events or evidence of dose-limiting toxicity. These results supported the Company’s application to the Japanese PMDA for the initiation of clinical trial sites to evaluate VS-6063 in Japanese patients with mesothelioma.

“COMMAND is now open for patient enrollment at multiple sites in Japan,” said Dr. Joanna Horobin, Verastem chief medical officer. “An important element of our overall global development strategy for VS-6063 is to pursue a path toward registration in Japan in parallel with our development efforts worldwide. We are committed to developing new treatments that can potentially make a meaningful difference in the lives of patients suffering with this deadly disease.”