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Oncology Advances Spring 2015

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Dana-Farber/Brigham and Women's Cancer Center | 3 (an anti-PD-1 agent) administered to participants with ad- vanced biomarker-positive solid tumors that have not re- sponded to current therapy, for which current therapy is not appropriate, or for which no current therapy exists; • Early 2015 Studies – Two additional clinical trials will open in early 2015, including a Phase II study of pembrolizumab with or without bevacizumab for patients with recurrent glioblastoma and a Phase II study of MEDI-4736, an anti- PD-L1 agent, for patients with newly-diagnosed and re- current glioblastoma, including patients who have had progressive disease after treatment with bevacizumab. Targeted Therapies • Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation – This Phase I, multicenter study is evaluating the safety, pharmacokinetics, pharmacodynamics and clin- ical activity of AG-120, the first-in-class inhibitor of IDH-1 available for clinical trials, in advanced solid tumors, in- cluding glioma, that harbor an IDH1 mutation. The study's dose escalation will determine maximum tolerated dose and/or the recommended Phase II dose. The dose expan- sion phase will evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression or un- acceptable toxicity occurs. • Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Gliobastoma – This Phase Ib/II, multicenter study is assessing the safety and the dose of the combination of INC280, an oral met inhibitor, and buparlisib (BKM120), an oral PI3K inhibitor, as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozy- gous deletion of PTEN or PTEN negative by IHC. For more information, or to refer a patient for these and other trials offered at the Center for Neuro-Oncology, please visit dfbwcc.org/clinicaltrials or contact Director Patrick Y. Wen, MD, or Clinical Director David A. Reardon, MD, at (617) 632-2166. Patrick Y. Wen, MD Director, Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center David A. Reardon, MD Clinical Director, Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center One of the nation's most comprehensive personalized medicine initiatives in cancer, Profile is a joint research study led by oncologists and pathologists at Brigham and Women's Hospital and Dana-Farber Cancer Institute. Enrollment is offered to every Dana-Farber/Brigham and Women's Cancer Center pa- tient. Since the study's launch three years ago, the Profile research team has compiled genotyping or sequencing data from more than 10,000 cancer patients. Profile's current platform, OncoPanel, uses next-generation sequencing to screen more than 300 genes, detecting: • mutations, • insertions and deletions, • copy number changes, • structural rearrangements. Results from the study have supported the development of new research studies and have informed care for many patients, either with standard targeted therapy or clinical trial enrollment. "The power of Profile lies in the volume of the data it is amassing on the genetics of cancer, and the potential to correlate distinctive DNA abnormalities in a specific patient's cancer with its behavior and how it responds to treatment," explained Barrett J. Rollins, MD, PhD, a Profile study leader and Chief Scientific Officer at Dana-Farber Cancer Institute. Dana-Farber/Brigham and Women's Cancer Center News – Profile Study Reaches New Heights

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