PROSPECT is an open-label, Phase II study evaluating the
efficacy, safety, and pharmacokinetics of an investigational
oral medicine called tirabrutinib (ONO-4059), a Bruton’s
tyrosine kinase (BTK) inhibitor, in patients with primary
central nervous system lymphoma (PCNSL).

This study is actively recruiting. Information about local site coordination is available on clinicaltrials.gov. To learn more about this study, visit Study Details | Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) | ClinicalTrials.gov

Read the Prospect Study Brochure HERE.

Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd., is a highly potent second-generation selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. Gene expression profiling data revealed BCR signaling as the most prominent pathway activated in chronic lymphocytic leukemia (CLL) cells isolated from lymphatic tissues.

In Japan, Tirabrutinib was approved in March 2020 for the treatment of relapsed or refractory PCNSL and launched under the tradename of Velexbru® in May 2020. In addition, Velexbru® was approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in Japan in August 2020. It has not been approved in any other countries outside of Japan.

ABOUT ONO PHARMA

ONO has a history of tackling challenges: It has overcome difficulties and changes, clearing its own unique path. For more than 300 years since our founding, our enthusiasm and spirit for drug development. We will continue tackling challenges for drug development and have driven creation of innovative new drugs to satisfy people's desire to stay healthy.

INNOVATION
Creation of innovative new drugs with researchers around the world in collaboration with Nobel winner researchers who have the world's leading-edge knowledge and technology, we have created 12 prostaglandin products and a cancer immunotherapy. Currently, we are conducting joint research projects with universities, research institutes and biopharmaceutical companies inside and outside Japan.