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Oncology-Advances-January-2016

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6 | Oncology Advances Building on recent discoveries at Dana-Farber/Brigham and Women's Cancer Center using a variety of inhibitor combina- tions, researchers in the Susan F. Smith Center for Women's Cancers are leading new early-phase trials for patients with ovarian cancer. "We are looking at new targeted approaches for patients with ovarian cancer, using biomarkers and other key information to identify specific patient populations that are most likely to respond to certain treatments," said Ursula Matulonis, MD, Director of the Center's Gynecologic Oncology Program. "Given the genetic complexity of the most common type of ovarian cancer, serous cancer, our group thinks that combina- tion therapies as a strategy are very promising." Findings in PARP Combination Studies At the 2015 American Association for Cancer Research (AACR) Annual Meeting, Dr. Matulonis presented final results of a Phase I study of the combination of the poly ADP-ribose poly- merase (PARP) inhibitor olaparib and the phosphatidylinositol- 3-kinase (PI3K) inhibitor BKM120 in patients with high-grade serous ovarian cancer, as well as triple-negative breast cancer. The study demonstrated the safety of the combination and showed efficacy in both BRCA-mutant and BRCA-wildtype cancers. A previous multi-center phase II trial, Combination Cediranib and Olaparib versus Olaparib Alone for Women with Recurrent Platinum-sensitive Ovarian Cancer (Lancet Oncol. 2014 Oct;15(11):1207-14), led by the overall Principal Investigator Joyce Liu, MD, MPH, and co-PI Dr. Matulonis compared the combination of olaparib and cediranib, an anti-angiogenic agent, with olaparib alone in patients with ovarian cancer. The trial not only showed that the combination was more active than olaparib alone but that activity was observed in both BRCA-mutation carriers and BRCA non-carrier participants. New Early-phase Studies The team is currently expanding its Phase I and Phase II trials using PARP inhibitors, immunotherapies, antibody drug con- jugates, and other agents, to include new combinations and patient populations. Current and upcoming studies include: • Phase I/II trial of Niraparib, a PARP inhibitor, plus pem- brolizumab, an anti-PD-1 immunotherapy agent, in patients with ovarian and breast cancers. Site Principal Investigator: Panagiotis A. Konstantinopoulos, MD, PhD; • Phase I dose-expansion study of BYL719 or BKM120, both PI3K inhibitors, with olaparib in patients with high-grade serous ovarian cancer and recurrent triple negative breast cancer. National Principal Investigator: Ursula Matulonis, MD; Early-phase Trials at Dana-Farber/Brigham and Women's Cancer Center Explore Novel Combinations for Ovarian Cancer • Phase 1 study of ricolinostat, an oral HDAC6 inhibitor, to- gether with weekly paclitaxel in recurrent platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Site Principal Investigator: Joyce Liu, MD, MPH; • Phase II single-arm study of niraparib in patients with ad- vanced, high-grade serous ovarian cancer (with or without BRCA germline mutations), fallopian tube, or primary peri- toneal cancer, who have received at least three previous chemotherapy agents. Site Principal Investigator: Ursula Matulonis, MD; • Phase I, multicenter, dose-escalation study of DMUC4064A, an antibody drug conjugate, in patients with platinum-re- sistant ovarian cancer or unresectable pancreatic cancer. Site Principal Investigator: Joyce Liu, MD, MPH; • Phase Ib multicenter study to evaluate the combination of DNIB0600A, another antibody drug conjugate, together with carboplatin in patients with platinum-sensitive ovarian cancer. Site Principal Investigator: Joyce Liu, MD, MPH. (For information on these trials, please contact Christin Whalen, RN, at cwhalen@partners.org or (617) 582-7738) "These early-phase studies enable us the ability to offer addi- tional options for patients with advanced ovarian cancer and evaluate the effects of new drug types and combinations in extending survival," said Dr. Liu. Joyce Liu, MD, MPH Medical Oncologist, Gynecologic Oncology Program, Susan F. Smith Center for Women's Cancers, Dana-Farber/Brigham and Women's Cancer Center Ursula Matulonis, MD Director, Gynecologic Oncology Program, Susan F. Smith Center for Women's Cancers, Dana-Farber/Brigham and Women's Cancer Center Medical oncologist Joyce Liu, MD, MPH, and Ursula Matulonis, MD, Director of the Gynecologic Oncology Program at Dana-Farber/Brigham and Women's Cancer Center, are leading new early-phase trials for patients with ovarian cancer.

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