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TESARO, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Estimated Enrollment: 490
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT01847274

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Niraparib (MK-4827) Breast Cancer BRCA+OncologyBreast Cancer (BRCA +)PARP inhibitorPARP

Mechanism of action: Niraparib (MK-4827) is an inhibitor of poly (ADP-ribose) polymerase (PARP) with potential antineoplastic activity. Niraparib inhibits PARP activity, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. The PARP family of proteins detect and repair single strand DNA breaks by the base-excision repair (BER) pathway. The specific PARP family member target for Niraparib is unknown.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-10-01 - 2016-12-31

Results:

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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."
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Source: press release, 7/08/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=978755

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