Approval for the first-line treatment of unresectable advanced or recurrent gastric cancer
This approval is based on the results from the following 2 clinical studies:
CheckMate -649 study (ONO-4538-44): A global multi-center, randomized, open-label Phase 3 clinical study, evaluating Opdivo plus chemotherapy or Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy alone in patients with previously untreated, non-human epidermal growth factor receptor 2 (non-HER2)-positive, unresectable advanced or recurrent gastric cancer (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (ESA), conducted on a world-wide basis including
In this study, Opdivo plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival (OS) both in all randomized patient population and OS in PD-L1 positive patients with a combined positive score (CPS) 5, one of the primary endpoints, versus chemotherapy. Furthermore, Opdivo plus chemotherapy demonstrated a statistically significant extension in progression-free survival (PFS) in PD-L1 positive patients with CPS ?5, the other primary endpoint, versus chemotherapy. The safety profile of Opdivo plus chemotherapy in the study was consistent with the known safety profiles of the individual treatments.
ATTRACTION-4 study (ONO-4538-37): A multi-center, randomized Phase 2/3 clinical study, evaluating Opdivo plus chemotherapy compared to placebo plus chemotherapy in patients with previously untreated, HER-2 negative, unresectable advanced or recurrent GC or GEJC, conducted in
In this study, Opdivo plus chemotherapy showed a statistically significant extension in PFS, one of the primary endpoints, versus placebo plus chemotherapy. On the other hand, Opdivo plus chemotherapy did not demonstrate a statistically significance in OS, the other of the primary endpoints. The safety profile of Opdivo plus chemotherapy in the study was consistent with the known safety profiles of the individual treatments.
About CheckMate -649 study (ONO-4538-44)
Checkmate -649 is a multi-center, randomized, open-label Phase 3 clinical study, evaluating Opdivo plus chemotherapy or Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, unresectable advanced or recurrent gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 240 mg plus fluorouracil, calcium folinate and oxaliplatin (FOLFOX) every two weeks or Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment up to 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. Key secondary endpoint is OS in CPS 1 and all-randomized patients treated with Opdivo plus chemotherapy.
About ATTRACTION-4 study (ONO-4538-37)
ATTRACTION-4 study is a multi-center, randomized Phase 2/3 clinical study, evaluating Opdivo plus chemotherapy (oxaliplatin + S-1 or capecitabine) compared to placebo plus chemotherapy in patients with previously untreated, HER2 negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. Patients received Opdivo 360 mg or placebo every 3 weeks until disease progression or unacceptable toxicity is observed. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS).
About Gastric cancer
It is estimated that about 138,000 new cases 1) are diagnosed with gastric cancer per year in
Globocan 2020: Stomach Cancer,
Globocan 2020: Stomach Cancer, World,
Approval for the adjuvant treatment of esophageal cancer
This approval is based on the results from a global multi-center, randomized, double-blind Phase 3 clinical study, CheckMate -577 study (ONO-4538-43), evaluating Opdivo monotherapy as an adjuvant treatment in patients with resected esophageal cancer (ESC) or gastroesophageal junction cancer (GEJC) compared to placebo.
In this study, Opdivo showed a statistically significant improvement in disease-free survival (DFS), the primary endpoint of the study, compared to placebo. The safety profile of Opdivo in this study was consistent with previously reported studies of Opdivo monotherapy.
About CheckMate -577 study (ONO-4538-43)
CheckMate -577 study is a global multi-center, randomized, double-blind Phase 3 clinical study, evaluating Opdivo monotherapy as an adjuvant treatment in patients with resected esophageal cancer or gastroesophageal junction cancer (GEJC)
About esophageal cancer
Esophageal cancer is a malignant tumor that occurs in the inner layer (mucosa) of the esophagus and grows outside (toward the deeper layer). There are two main histological types of esophageal cancer; squamous cell carcinoma (SCC) and adenocarcinoma. SCC is the predominant type accounting for about 90% of all esophageal cancer in
Globocan 2020: Esophageal Cancer,
Globocan 2020: Esophageal Cancer, World, World Health Organization Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
Guideline for Diagnosis and Treatment of Carcinoma of the Esophagus 2017,
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 has submitted supplemental applications for the adjuvant treatment of urothelial cancer and cancer of unknown primary, and is conducting clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, pancreatic cancer, biliary tract cancer, etc.
About the ONO and Bristol-Myers Squibb Collaboration
In 2011, through a collaboration agreement with
Contact:
Corporate Communications
E: public_relations@ono.co.jp
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