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

March 6, 2018  Source: ir.tesarobio 136

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.

 

By Ddu
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