This approval is based on the result from the global, multi-center, randomized, open-label Phase 3 CheckMate -9ER study, evaluating Opdivo and cabozantinib combination therapy versus sunitinib alone in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). In this study, Opdivo and cabozantinib combination therapy demonstrated a significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR), compared to sunitinib alone at the final analysis, as well as the secondary endpoints of overall survival (OS) and objective response rate (ORR) as assessed by the BICR. The safety profiles of Opdivo and cabozantinib combination therapy observed in the study were consistent with the previously reported safety profile of each product.
About Checkmate -9ER Study
CheckMate -9ER study is a global, multi-center, randomized, open-label Phase 3 study, evaluating Opdivo and cabozantinib combination therapy in patients with previously untreated advanced or metastatic RCC, versus sunitinib alone. Patients were randomized 1:1 to the Opdivo and cabozantinib combination therapy group receiving Opdivo 240 mg by intravenous infusion every 2 weeks and cabozantinib 40 mg orally once daily, or the control group receiving sunitinib 50 mg orally once daily for 4 weeks, followed by a 2-week non-treatment period until disease progression or unacceptable toxicity. The primary endpoint of the study was progression-free survival (PFS) as assessed by the blinded independent central review (BICR). The secondary endpoints were overall survival (OS) and objective response rate (ORR) as assessed by the BICR.
About Kidney Cancer
Kidney cancer is a malignant tumor arising from the renal parenchyma. Among kidney cancer, renal cell carcinoma (RCC) is the most common cancer, constituting almost 90% of all kidney cancer1. It is estimated that 1,615 new cases of kidney cancer are diagnosed per year (RCC: about 1,530) and 599 deaths per year result from this disease in Taiwan2.
1. The epidemiology of renal cell carcinoma. Euro Urol. 2011;60;615-621.
2. 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, etc.
About ONO and Bristol Myers Squibb Collaboration
In 2011, through a collaboration agreement with
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