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Oncology Advances April 2016

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6 | Oncology Advances Raphael Bueno, MD, is leading research that is studying defactinib in patients with surgically-resectable malignant pleural mesothelioma. Experts at Dana/Farber/Brigham and Women's Cancer Center (DF/BWCC) presented preliminary results of an ongoing Phase II investigator-initiated neoadjuvant study of defactinib in pa- tients with surgically-resectable malignant pleural mesothe- lioma (MPM) at the International Mesothelioma Interest Group's 2014 Conference and have modified the trial for sub- sequently enrolled patients. "Because we have reached maximum efficacy using currently available treatment methods for mesothelioma, it is imperative that we identify new biologic agents to advance care for pa- tients with this disease," said Raphael Bueno, MD, Chief of the Division of Thoracic Surgery at Brigham and Women's Hospital and Senior Surgeon at DF/BWCC. Window of Opportunity Study Preliminary results of the Window of Opportunity Study of VS- 6063 (Defactinib) in Patients with Surgically Resectable Malig- nant Pleural Mesothelioma incorporated 10 patients who received the focal adhesion kinase (FAK) inhibitor defactinib (400 mg BID orally) for 10 to 14 days, followed by surgical re- section of the tumor 30 days after the last dose of defactinib. The age range among the patients (eight male and two fe- male) was 55 to 83 years, with a median age of 71. Pre- and post-treatment biopsies and PET-CT imaging were performed. Biopsy samples were analyzed using immunohistochemistry, next generation sequencing, and RNA sequencing. Novel Neoadjuvant Trial Demonstrates Biomarker Response in Patients with Malignant Pleural Mesothelioma The drug was well tolerated among the 10 patients, with only Grade 1 or Grade 2 adverse events reported. Biologic marker response was observed, with mean pFAK (Y397) reduced by 70 percent in patients evaluated to date. Other stem cell mark- ers, including CD133, CXCR2, SOX2, and POSTN, were also reduced in the majority of patients. In addition, pre- and post- treatment PET-CT imaging demonstrated significant decrease in tumor size (see Figures 1 and 2). Figure 1

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