ENGOT and TESARO Partnership Generates Positive Data From ENGOT-OV16/NOVA Phase 3 Trial

  • The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort
  • The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint of PFS in the non-germline BRCA mutant cohort, including both the HRD-positive and overall analysis populations
  • ENGOT-OV16/NOVA is the first successful prospectively designed Phase 3 trial of a PARP inhibitor
  • NDA and MAA submissions are planned for Q4 2016

BERLIN, July 08, 2016 (GLOBE NEWSWIRE) -- ENGOT (European Network of Gynaecological Oncology Trial Groups), today announced that the Phase 3 ENGOT-OV16/NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). This trial is led by NSGO (Nordic Society of Gynaecological Oncology) in partnership with TESARO, Inc. and is the first successful Phase 3 trial of a PARP inhibitor to be completed in ovarian cancer. More than 500 patients with recurrent disease who were in response to their most recent platinum-based chemotherapy regimen enrolled in the trial.

As previously reported, this trial demonstrated that niraparib significantly prolonged PFS compared to control among patients who are germline BRCA mutation (gBRCAmut) carriers, among patients who are not germline BRCA mutation (non-gBRCAmut) carriers but who have homologous recombination deficient (HRD) tumors as determined by the Myriad myChoice®HRD test, and overall in patients who are not germline BRCA mutation carriers.

“The data suggest that niraparib, if approved, will be a step forward in the management of our patients and a potential new treatment option for ovarian cancer patients,” said Mansoor Raza Mirza, M.D., Study Chair and Medical Director of NSGO.

“ENGOT with their collaborative clinical trial groups has put a lot of effort to bring this trial to success and this is a great example how today international collaboration between academic groups and industry can benefit patients,” said Christian Marth, President of ENGOT.

“We are extremely grateful to the patients, caregivers, and investigators, including our partners at ENGOT, who participated in this trial. The results of this study demonstrate that a single, daily, oral dose of niraparib is superior to control in prolonging PFS in women with recurrent ovarian cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “In keeping with our mission of responsible drug development, ENGOT-OV16/NOVA was designed to define those patients most likely to benefit from niraparib treatment and, in so doing, optimize the benefit/risk profile for patients. We believe we have achieved that goal and look forward to our presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) congress in October.”

About the Phase 3 ENGOT-OV16/NOVA Clinical Trial
NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that planned to enroll 490 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut). The non-gBRCAmut cohort included patients with HRD-positive tumors, including those with somatic BRCA mutations and other HR defects, and patients with HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS2, overall survival, and other measures of safety and tolerability.

The most common (≥10%) treatment-emergent grade 3/4 adverse events among all patients treated with niraparib were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). Adverse events were generally managed via dose modifications. The discontinuation rate was 14.7% for niraparib treated patients and 2.2% for control.

More information about this trial is available at http://clinicaltrials.gov/show/NCT01847274.

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

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes the Phase 3 trial in patients with ovarian cancer (the NOVA trial) as described above; a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); a Phase 3 trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial); and a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial). Several collaborator-sponsored studies are also underway, including combination trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan

The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology (ESGO) and was founded in Berlin in October 2007. Currently, ENGOT consists of 19 trial groups from 15 European countries that perform cooperative clinical trials. ENGOT's ultimate goal is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.

About NSGO
Nordic Society of Gynaecological Oncology (NSGO) is a non-political, non-profit society dedicated to initiate, promote and conduct collaborative clinical trials in gynaecological cancers. NSGO in the past 30 years has successfully contributed to bring novel cancer agents to registration. NSGO is one of the leading collaborative groups within ENGOT as well as within Gynecologic Cancer InterGroup (GCIG).

TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.

TESARO 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, statements regarding our expectation to submit the NDA and MAA for niraparib in the fourth quarter of 2016 and to present the full NOVA data set at an upcoming medical meeting. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, 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, competition from other pharmaceutical companies, 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 and event rates for clinical trials, and other matters that could affect the timing of availability of data from or initiation of our clinical trials, uncertainties regarding regulatory approvals, risks related to manufacturing and supply, uncertainties regarding certain expenditures, 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 Annual Report on Form 10-K for the year ended December 31, 2015, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2016.

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

Source:TESARO, Inc.