Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; “ONO”) announced that Ono Pharma Taiwan Co., Ltd. (“OPTW”), a Taiwanese subsidiary of ONO, received the additional approval of Opdivo (nivolumab) Intravenous Infusion 20 mg, 100 mg Inj. ("Opdivo"), a human anti-human PD-1 monoclonal antibody, on October 14 in Taiwan from the Taiwan Food and Drug Administration (TFDA) for the treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression level, without human epidermal growth factor receptor 2 (HER2) overexpression, in combination with fluoropyrimidine- and platinum-containing chemotherapy.
This approval is based on the results from the global, multi-center, randomized, open-label Phase 3 CheckMate -649 study, evaluating Opdivo plus chemotherapy combination treatment compared to chemotherapy alone in patients with previously untreated, non-HER2 positive, advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC). In this study, Opdivo plus chemotherapy combination treatment demonstrated a statistically significant improvement of overall survival (OS) both in all randomized patients and in PD-L1 positive patients with a combined positive score (CPS) ≥ 5 versus chemotherapy. The safety profile of Opdivo plus chemotherapy in this study was consistent with the known safety profile of the individual treatments.
About CheckMate -649 Study
Checkmate -649 study is a multi-center, randomized, open-label Phase 3 clinical study evaluating Opdivo plus chemotherapy combination treatment compared to chemotherapy alone in patients with previously untreated, non-HER2 positive, advanced or metastatic GC, GEJC or EAC. Patients in the Opdivo plus chemotherapy arm received Opdivo 240 mg plus 5-fluorouracil, leucovorin 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 for two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the study are OS in PD-L1 positive patients with a CPS ≥ 5 and PFS as assessed by Blinded Independent Central Review (BICR) in CPS ≥ 5 patients, compared to chemotherapy alone. Key secondary endpoints are OS and PFS in PD-L1 positive patients with CPS ≥1 and in all randomized patients, and overall response rate (ORR) as assessed by BICR in PD-L1 positive patients with CPS ≥ 1 and ≥ 5, and in all randomized patients.
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Date: Oct 20, 2021
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