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TESARO Announces Completion of Targeted Enrollment in Phase 3 NOVA Trial and Initiation of the QUADRA Trial of Niraparib

  • Both the non-germline and germline BRCA mutation cohorts within NOVA are fully enrolled
  • Phase 3 data from NOVA is expected in Q4 2015
  • Patients are now being treated within the QUADRA trial

WALTHAM, Mass., April 30, 2015 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today provided an update on its niraparib clinical development program. The targeted enrollment has been achieved in both patient cohorts of the Phase 3 NOVA trial of niraparib, and TESARO expects data from NOVA in the fourth quarter of 2015. In addition, the QUADRA treatment trial of niraparib has been initiated, and initial data from this trial is anticipated in early 2016.

"Our goal is to establish a broad franchise in ovarian cancer by evaluating niraparib in several patient populations and across multiple potential indications," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We expect data from the NOVA trial in the fourth quarter of this year, the QUADRA and AVANOVA trials are currently underway, and planning is ongoing to support initiation of the PRIMA trial of niraparib in the first-line ovarian cancer maintenance during the second half of this year."

About the NOVA Study

The NOVA (Niraparib Ovarian) study is a double blind, placebo-controlled, international Phase 3 trial of niraparib with a target enrollment of 490 patients with high grade serous, platinum sensitive, relapsed ovarian cancer. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. Within each cohort, patients were be randomized 2:1 to receive niraparib or placebo, and will be continuously treated with placebo or 300 milligrams of niraparib until progression. The primary endpoint of this study is progression free survival. Secondary endpoints include patient reported outcomes, chemotherapy free interval length, and overall survival. More information about this trial is available at www.novaclinicaltrial.com or http://clinicaltrials.gov/show/NCT01847274.

About the QUADRA Study

The QUADRA study is a single arm, Phase 2 clinical trial that is targeted to enroll 225 patients with high grade serous ovarian cancer who have received three or more prior lines of chemotherapy. Endpoints include objective response rate (ORR) and duration of response for the entire population, as well as for platinum sensitive, platinum resistant, germline BRCA and HRD (homologous recombination deficient) patient subsets. More information about this trial is available at https://clinicaltrials.gov/show/NCT02354586.

About the AVANOVOA Study

AVANOVA is a Phase 1/2 trial designed to evaluate the efficacy of niraparib in combination with bevacizumab in approximately 147 patients with recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. In the phase 1 open label, dose escalation portion of this study, patients will receive a combination of bevacizumab plus niraparib, with a goal of determining the dose for Phase 2. In the Phase 2 portion of the study, patients will be randomized to receive niraparib and/or the niraparib-bevacizumab combination or bevacizumab alone. The primary endpoint of this trial is PFS. This trial is being conducted in collaboration with The European Network for Gynaecological Oncological Trial groups (ENGOT). More information is available at https://clinicaltrials.gov/ct2/show/NCT02354131.

Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA or any regulatory agencies.

About TESARO

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.

Forward Looking Statements

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. Examples of forward looking statements contained in this press release include, among others, our expectation to have Phase 3 NOVA data in the fourth quarter of 2015 and initial QUADRA data in early 2016, and our plans to initiate additional niraparib trials in the first-line ovarian cancer maintenance and SCLC settings in the second half of the year. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our 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 execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, patient accrual rates for clinical trials, and other matters that could affect the timing of availability of data from or initiation of our clinical trials. 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 Annual Report on Form 10-K for the year ended December 31, 2014.

CONTACT: Investor/Media Contact: Jennifer Davis Sr. Director, Corporate Development & Investor Relations +1.781.325.1116 or jdavis@tesarobio.com

Source:TESARO, Inc.