About CheckMate -649 study (ONO-4538-44)
Checkmate -649 is a randomized, multi-center, open-label Phase 3 clinical study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy alone in patients with previously untreated, non-human epidermal growth factor receptor 2 (HER2) positive, advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5- fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks. Patients in the Opdivo plus Yervoy arm received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles followed by Opdivo 240 mg every two weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the study are overall survival (OS) in PD-L1 positive patients with a combined positive score (CPS) 5 treated with Opdivo plus chemotherapy and progression-free survival (PFS) in CPS 5 patients treated with Opdivo plus chemotherapy compared to chemotherapy alone. Key secondary endpoints include OS in CPS 1 and all-randomized patients treated with Opdivo plus chemotherapy as well as OS and time to symptom deterioration (TTSD) in patients treated with Opdivo plus Yervoy compared to chemotherapy alone.
About ATTRACTION-4 study (ONO-4538-37)
ATTRACTION-4 study is a multi-center, randomized Phase 2 / 3 clinical study evaluating Opdivo in combination with chemotherapy (oxaliplatin + S-1 or capecitabine) compared to placebo in combination with chemotherapy in patients with HER2 negative previously untreated unresectable advanced or recurrent gastric cancer (including esophago-gastric junction cancer). Patients received Opdivo 360 mg or placebo every 3 weeks until disease progression or unacceptable toxicity is observed. The primary endpoints of this study are PFS and OS. The secondary endpoint is overall response rate (ORR).
About Gastruc cancer
It is estimated that about 115,000 new cases are diagnosed with gastric cancer per year in
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, hepatocellular carcinoma, glioblastoma, urothelial cancer, ovarian cancer, bladder cancer, pancreatic cancer, biliary tract cancer, prostate cancer, etc.
About the ONO and Bristol-Myers Squibb Collaboration
In 2011, through a collaboration agreement with
Contact:
Email: publicrelations@ono.co.jp
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