CHICAGO and BRUSSELS, June 3, 2013 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, Breast International Group (BIG), a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment of Cancer (EORTC), an international, independent, multidisciplinary non-profit research organization, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor.
TESARO, BIG and EORTC will utilize BIG’s and EORTC’s scientific and clinical expertise and network of collaborative groups and their associated hospitals and oncology research centers around the world to accelerate completion of the Phase 3 clinical trial of niraparib in patients with breast cancer. This collaboration enables BIG and member group EORTC as well as TESARO to involve key opinion leaders to optimize the clinical study design, data analyses and publication planning.
“As a leading international network of academic research groups, we look forward to partnering with TESARO to advance this potential new therapy for patients with breast cancer,” said Dr. Martine Piccart, Chair of BIG. “We are very interested in evaluating the potential for niraparib to prolong progression free survival in comparison to commonly used chemotherapy treatments in patients with germline BRCA mutations, and believe that such an advance could be very meaningful for patients.”
“We are pleased to be collaborating with the clinical and scientific experts at BIG and EORTC to optimize the niraparib clinical study design and accelerate the international site enrollment and development of niraparib,” said Mary Lynne Hedley, Ph.D., President of TESARO. “We look forward to opening this study to patients during the second half of 2013.”
This global Phase 3 trial of niraparib which will be conducted in partnership with BIG and the EORTC at the European study sites is planned to enroll approximately 300 patients with advanced or metastatic, germline BRCA-positive breast cancer who have been previously treated with an anthracycline and a taxane. Patients will be randomized 2:1 to receive 300 milligrams of niraparib once daily or investigator’s choice of eribulin, capecitabine, gemcitabine or vinorelbine until progression. The primary endpoint of this trial is progression free survival (PFS); overall survival (OS) is a secondary endpoint.
About Breast International Group
The Breast International Group (BIG) is a non-profit organization for academic breast cancer research groups from around the world, with its headquarters in Brussels, Belgium. BIG facilitates and accelerates breast cancer research at the international level by stimulating cooperation between its members and other academic networks, and collaborating with, but working independently from, the pharmaceutical industry. For more information, visit www.breastinternationalgroup.org.
About the EORTC
The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration.
Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries.
Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices.
EORTC Headquarters, a unique pan European independent clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
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To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO’s Form 10-K for the year ended December 31, 2012.