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TESARO Announces Collaboration to Evaluate Combination of ZEJULA® (Niraparib) and Anti-PD-L1 Cancer Immunotherapy in Metastatic Bladder Cancer

WALTHAM, Mass., Feb. 26, 2018 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ®) and TESARO’s PARP-inhibitor ZEJULA® (niraparib) in patients with metastatic bladder cancer. 

“This collaboration enables us to expand the clinical assessment of niraparib and PD(L)-1 combinations beyond ovarian, breast and lung cancer,” said Mary Lynne Hedley, Ph.D., President and COO of TESARO. “The combination of these two therapies could provide a potential option for patients with advanced bladder cancer, for whom mechanisms of immune escape, despite significant recent advances with anti-PD(L)-1 agents, remain a clinically relevant unmet need.”

The collaboration includes testing the experimental combination in MORPHEUS, Roche's novel cancer immunotherapy development platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. The planned trial will be conducted by Genentech and is expected to begin mid-2018.

TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About ZEJULA (Niraparib)
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.

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 jdavis@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, statements regarding the potential use of niraparib in patients with bladder cancer and the potential timing of the planned clinical trial. Forward-looking statements in this release involve substantial risks and uncertainties that could cause 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, risks related to the execution and completion of clinical trials, risks related to manufacturing and supply, and other matters that could affect the timing or outcome of 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, 2016, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017.

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Source: TESARO, Inc.