Ono Pharmaceutical Co., Ltd. – Opdivo intravenous infusion approved for adjuvant treatment of esophageal cancer or gastroesophageal junction cancer in Taiwan
This approval is based on the result of a global, multicenter, randomized, double-blind, phase 3 clinical study, Study CheckMate -577 (ONO-4538-43), evaluating Opdivo as monotherapy as adjuvant therapy in patients with d ‘resected esophageal cancer or cancer of the gastroesophageal junction, 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 as monotherapy.
About the CheckMate -577 study (ONO-4538-43)
The CheckMate -577 study is a global, multicenter, randomized, double-blind, phase 3 clinical study evaluating Opdivo as monotherapy as adjuvant therapy in patients with resected esophageal cancer (ESC) or cancer of the gastroesophageal junction (CJGE) who received neoadjuvant radiochemotherapy (CRT) and did not obtain a complete pathological response. After neoadjuvant CRT and complete surgical resection of the tumor (also known as trimodal therapy), patients were randomized to receive Opdivo or placebo. In patients receiving Opdivo, it was given 240 mg every two weeks for 16 weeks, followed by Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with maximum total treatment time of one year. The primary endpoint of the study is disease-free survival (SSM) and the secondary endpoint is overall survival (OS).
About cancer of the esophagus and cancer of the gastroesophageal junction
Esophageal cancer (ESC) is a malignant tumor that occurs in the inner layer (lining) of the esophagus and grows outside (towards the deeper layer). There are two main histological types of CSE; Squamous cell carcinoma (SCC) and adenocarcinoma. SCC is the predominant type accounting for about 90% of all ESCs in
Cancer Registry Annual Report, 2018 Taiwan
Opdivo is a programmed death immune checkpoint-1 (PD-1) inhibitor designed to uniquely harness the body’s own immune system to help restore the anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s immune system to fight cancer, Opdivo has become an important treatment option for several cancers since the approval of melanoma treatment in
In addition, ONO has submitted an additional application for adjuvant treatment of urothelial cancer and is conducting a clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, cancer of the pancreas, cancer of the bile ducts, etc.
About the ONO and Bristol Myers Squibb collaboration
In 2011, thanks to a collaboration agreement with