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TESARO PROVIDES PIPELINE UPDATE AT ASCO INVESTOR BRIEFING

Rolapitant IV NDA accepted for review by FDA; PDUFA date is January 11, 2017
Sufficient PFS events reached for data analysis of both cohorts of Phase 3 niraparib NOVA trial; data expected in Q2 2016
IND for TSR-022 (anti-TIM-3 antibody) cleared by FDA; Phase 1 study to begin in mid-2016
CHICAGO, June 04, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today provided an update on its clinical development pipeline during an investor briefing and webcast held in conjunction with the American Society for Clinical Oncology (ASCO) 2016 annual meeting.

During the investor briefing, TESARO announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. The NDA for rolapitant IV is supported by data from a clinical program of approximately 350 subjects, and included a bioequivalence study and several other supportive non-clinical and clinical studies.

TESARO also provided an update on its Phase 3 NOVA trial of niraparib in patients with ovarian cancer. A sufficient number of progression free survival (PFS) events has been reached to trigger data analysis for both cohorts. Data cleaning is underway in preparation for database lock and release of top-line results. Finally, TESARO announced FDA clearance of its Investigational New Drug (IND) application for TSR-022, its anti-TIM-3 antibody candidate. A Phase 1 study for TSR-022 is planned to begin in mid-2016.

"We continue to make significant progress with our pipeline of oncology product candidates. The acceptance of the rolapitant IV NDA and clearance of TSR-022 IND are important milestones for TESARO and demonstrate our commitment to advancing new therapeutic options for patients," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "Our NOVA study results will be the first data from a prospectively designed, randomized, Phase 3 trial of a PARP inhibitor, and we look forward to sharing these data later this quarter."
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Source: press release, 6/04/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=974299

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Leon (Lonnie) O. Moulder, Jr., Chief Executive Officer, gave guidance for data from the NOVA and QUADRA trials and the enrollment of the BRAVO trial. He staed, "Our NOVA and QUADRA data is on track to become available during the second quarter with NDA and MAA submissions planed for the second half of this year. We will continue to enroll our phase-III BRAVO trial in patients with breast cancer throughout 2016."
Source: Q4 2015 earnings conference call, 2/25/16.

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"TESARO continues to make significant progress in advancing its pipeline of product candidates, and preparations for the commercial launch of oral rolapitant are well underway to support product introduction in the fourth quarter," said Lonnie Moulder, CEO of TESARO. ‎ "We have established our medical science liaison, nurse educator, and regional sales leadership teams, and the build-out of our field sales organization is nearly complete. The second half of 2015 ‎will be an exciting time for the Company, as we look ahead to the expected niraparib Phase 3 NOVA trial data in the fourth quarter of 2015, the NDA submission for IV rolapitant, and the initiation of our immuno-oncology clinical program in early 2016‎."

Phase 3 data from the NOVA trial of niraparib for patients with high-grade serous, platinum-sensitive, relapsed ovarian cancer is expected in the fourth quarter of 2015, following completion of enrollment in both cohorts earlier this year.
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Source: press release, 8/06/15. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=926418

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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) Ovarian cancer maintenanceOncologyOvarian Cancer (maintenance)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: 2016-06-06 - 2016-07-31

Results:

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TESARO'S NIRAPARIB SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL FOR PATIENTS WITH OVARIAN CANCER IN BOTH COHORTS OF THE PHASE 3 NOVA TRIAL

The NOVA trial successfully achieved its primary endpoint of PFS in the germline BRCA mutant cohort
The 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
NOVA is the first successful prospectively designed Phase 3 trial of a PARP inhibitor
NDA and MAA submissions are planned for Q4 2016
WALTHAM, Mass., June 29, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). 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.

An infographic accompanying this release is available at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/f065a7ab-070d-4dc3-8c...

Videos accompanying this release are available at:
http://www.globenewswire.com/NewsRoom/AttachmentNg/39793bb6-2551-47fa-85...

http://www.globenewswire.com/NewsRoom/AttachmentNg/6ea284b2-a663-4aeb-96...

NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. There is currently no therapy approved by the U.S. Food and Drug Administration for maintenance treatment of patients with recurrent ovarian cancer following response to platinum.

"We are extremely grateful to the patients, caregivers, and investigators who participated in the NOVA trial. The results of this study, which is the first successful, prospectively designed, randomized, well-controlled Phase 3 study of a PARP inhibitor, 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. "Importantly, these results show activity of niraparib in a population of ovarian cancer patients beyond those with germline BRCA mutations. In keeping with our mission of responsible drug development, 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 presentation of the full data set from this study at the European Society for Medical Oncology (ESMO) congress in October."

Statistically Significant PFS Results in the gBRCAmut Cohort
Among patients who were germline BRCA mutation carriers, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.27. The median PFS for patients treated with niraparib was 21.0 months, compared to 5.5 months for control (p < 0.0001).

Statistically Significant PFS Results in non-gBRCAmut Cohort for Patients with HRD Positive Tumors
For patients who were not germline BRCA mutation carriers but whose tumors were determined to be HRD positive using the Myriad myChoice® HRD test, the niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.38. The median PFS for patients with HRD-positive tumors who were treated with niraparib was 12.9 months, compared to 3.8 months for control (p < 0.0001).

Statistically Significant PFS Results in the Overall non-gBRCAmut Cohort
Niraparib also showed statistical significance in the overall non-germline BRCA mutant cohort, which included patients with both HRD-positive and HRD-negative tumors. The niraparib arm successfully achieved statistical significance over the control arm for the primary endpoint of PFS, with a hazard ratio of 0.45. The median PFS for patients treated with niraparib was 9.3 months, compared to 3.9 months for control (p < 0.0001).

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. The rates of MDS/AML in the niraparib (1.3%) and control (1.2%) arms were similar. There were no deaths among patients during study treatment.

"The majority of women who are diagnosed with advanced ovarian cancer will experience a relapse of their disease, even if they respond to their initial chemotherapy," said Dr. Tom Herzog, M.D., Clinical Director, University of Cincinnati Cancer Institute and Professor, Department of Obstetrics and Gynecology at the University of Cincinnati. "New treatment options are needed to extend the time in between cycles of platinum-based chemotherapy for these patients, and the results from the NOVA study suggest that niraparib could represent an important new treatment option for many patients with ovarian cancer."

"While the identification of mutations in the BRCA genes was a significant advancement, ovarian cancer remains the deadliest of gynecologic cancers, and new diagnostic and therapeutic options are needed," said David Barley, Chief Executive Officer of the National Ovarian Cancer Coalition. "The results of the NOVA trial are encouraging for patients and their families, and we look forward to seeing the full results of this study this fall."
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Source: press release, 6/29/16. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=977524

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