TESARO Announces Data Presentations at the 2018 American Association for Cancer Research Annual Meeting

WALTHAM, Mass., March 14, 2018 -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that data for ZEJULA, TSR-042 (anti-PD-1 antibody) and the company’s immuno-oncology portfolio will be presented at the 2018 American Association for Cancer Research (AACR) Annual Meeting, being held April 14-18, 2018 in Chicago.

“This year’s AACR annual meeting will mark the first presentation of initial data from the GARNET trial of TSR-042, our anti-PD-1 antibody, in patients with MSI-high endometrial cancer or non-small cell lung cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “TSR-042 provides a strategic advantage for TESARO in further developing niraparib and our immuno-oncology product candidates, and we expect to complete enrollment in the MSI-high registration trial at the end of this year. The breadth of our IO portfolio, which also includes antibodies targeting TIM-3 and LAG-3, enables TESARO to evaluate novel combination approaches with a goal of providing transformative therapies for people living with cancer.”

Please plan to visit TESARO at Booth #1645 for information on the expanded development program for ZEJULA, TSR-042 and our broader immuno-oncology portfolio.

Poster Information (all times local):

Immuno-oncology

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Preliminary safety, efficacy and PK/PD characterization from GARNET, a phase I clinical trial of the anti-PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced NSCLC or MSI-H endometrial cancer
Poster Session, Abstract: CT053, Location: Exhibit Hall A, Poster Section 42, Poster Board 6

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Checkpoint inhibitor signatures across endometrial cancer histologies
Poster Session, Abstract: 1687, Location: Exhibit Hall A, Poster Section 31, Poster Board 12

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Simultaneous measurement and significance of PD-1, LAG-3 and TIM-3 expression in human solid tumors
Poster Session, Abstract: 1681, Location: Exhibit Hall A, Poster Section 31, Poster Board 6

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Investigation of the expression profile and functional role of PD-1, TIM-3 and LAG-3 in human tumors
Poster Session, Abstract: 2722, Location: Exhibit Hall A, Poster Section 32, Poster Board 14

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Characterization of tumor growth and immune microenvironment in humanized NOG-EXL mice implanted with A549, MDA-MB-436 and A375 cells
Poster Session, Abstract: 5690, Location: Exhibit Hall A, Poster Section 31, Poster Board 26

ZEJULA^® (niraparib)

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Efficacy and pharmacokinetics of niraparib in BRCA-mutant and wild-type intracranial triple negative breast cancer murine models
Poster Session, Abstract: 2813, Location: Exhibit Hall A, Poster Section 37, Poster Board 3

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Evaluation of niraparib in combination with anti-PD1/anti-PD-L1 in preclinical models
Poster Session, Abstract: 1724, Location: Exhibit Hall A, Poster Section 32, Poster Board 19

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Enhanced anti-tumor effects of selinexor and niraparib in preclinical models of ovarian cancer
Poster Session, Abstract: 5826, Location: Exhibit Hall A, Poster Section 37, Poster Board 22

Niraparib is marketed in the United States and Europe under trade name ZEJULA^®.

About ZEJULA^® (niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA^®. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.  In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment.  ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

About TESARO
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.

Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Communications & Investor Relations
+1.781.325.1116 or [email protected]

Kate Rausch
Associate Director, Investor Relations
+1.781.257.2505 or [email protected]

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 in this release 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 expectations with respect to the timing for completing enrollment in the MSI-high registration trial for TSR-042, the timing of regulatory submissions and approvals for niraparib or the company’s immuno-oncology portfolio, 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. 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, 2017, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2017.