This approval is based on the results from the global multi-center, randomized, double-blind Phase 3 CheckMate -274 study (ONO-4538-33), evaluating Opdivo monotherapy compared to placebo as an adjuvant treatment in patients with muscle-invasive urothelial carcinoma at a high risk of recurrence after radical surgery. In this study, Opdivo showed a statistically significant improvement in disease-free survival (DFS), compared to placebo, both in all randomized patients and in patients whose tumor cells express PD-L1 ?1%, the primary endpoints of the study. The safety profile of Opdivo in this study was consistent with previously reported studies with Opdivo in solid tumors.
About CheckMate -274 Study (ONO-4538-33)
CheckMate -274 study is a global multi-center, randomized, double-blind Phase 3 study evaluating Opdivo monotherapy compared to placebo in patients who have undergone radical resection of muscle-invasive urothelial carcinoma originating in the bladder or upper urinary tract (renal pelvis or ureter) and are at a high risk of recurrence. In this study, patients were randomized 1:1 to receive Opdivo 240 mg or placebo every two weeks. Patients continued treatment for up to one year, until disease recurrence, unacceptable toxicity or withdrawal of consent. The primary endpoints of the study are disease-free survival (DFS) in all randomized patients and in patients whose tumor cells express PD-L1 ?1%. Key secondary endpoints are overall survival (OS), non-urothelial tract recurrence free survival and disease-specific survival.
About Urothelial Carcinoma
Urothelial carcinoma is a tumor that begins in the renal pelvis, ureter, bladder and urethra, most of which is bladder cancer. Histopathologically, urothelial carcinoma (transitional epithelial cancer) accounts for more than 90% of bladder cancer1). It is estimated that about 2,400 new cases of bladder cancer are diagnosed per year and about 1,100 deaths per year result from this disease in Taiwan2).
Lynch CF, Cohen MB. Urinary System. Cancer. 1995;75:316-29.
Cancer Registry Annual Report, 2019 Taiwan
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in
In
In addition, ONO is conducting clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, pancreatic cancer, biliary tract cancer, etc.
About ONO and Bristol Myers Squibb Collaboration
In 2011, through a collaboration agreement with
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Email: public_relations@ono.co.jp
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