This application is based on the results of interim analysis from a global multi-center, randomized, open-label Phase III clinical study (CheckMate -743 study), evaluating Opdivo plus Yervoy combination treatment, compared to standard of care platinum-based chemotherapy (combination therapy with pemetrexed and either of cisplatin or carboplatin) for the first-line treatment of patients with unresectable malignant pleural mesothelioma. In this analysis, Opdivo plus Yervoy combination treatment demonstrated a significant extension of overall survival (OS), the primary endpoint, versus chemotherapy. The safety profile of Opdivo plus Yervoy combination treatment observed in this study was consistent with those previously reported in the studies for the combination treatment.
Malignant pleural mesothelioma (MPM) is a malignant tumor derived from undifferentiated mesenchymal cells of the mesothelium covering the thoracic surface and its underlying connective tissue. It is estimated that there are about 2,000 affected patients with MPM in
About CheckMate -743
CheckMate -743 is a global multi-center, randomized, open-label Phase 3 trial evaluating Opdivo plus Yervoy combination treatment compared to chemotherapy (combination treatment of pemetrexed and either of cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (n=605). In the trial, 303 patients were randomized to receive Opdivo at 3 mg/kg every two weeks and Yervoy at 1 mg/kg every six weeks for up to 24 months or until disease progression or unacceptable toxicity, and 302 patients were randomized to receive cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 21-day cycles for six cycles or until disease progression or unacceptable toxicity. The primary endpoint of the trial was OS in all randomized patients. Key secondary endpoints were objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
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 esophago-gastric junction cancer, small cell lung cancer, hepatocellular carcinoma, glioblastoma, urothelial cancer, ovarian cancer, bladder cancer, pancreatic cancer, biliary tract cancer, etc.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody, and binds to the cytotoxic T-lymphocyteassociated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4, and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including anti-tumor immune response. On
About the ONO and Bristol-Myers Squibb Collaboration
In 2011, through a collaboration agreement made between ONO and
Contact:
Email: publicrelations@ono.co.jp
(C) 2020 Electronic News Publishing, source