Two combination treatments of Opdivo + Yervoy and Opdivo + chemotherapy approved in Japan for first-line treatment of unresectable advanced or recurrent esophageal cancer.
Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. have announced that the companies have received an approval in Japan for the combination treatment of Opdivo 9nivolumab) Intravenous Infusion (“Opdivo”), an anti-PD-1 antibody, and Yervoy (ipilimumab) Injection (“Yervoy”), an anti-CTLA-4 antibody, for the first-line treatment of unresectable, advanced or recurrent esophageal cancer.
This approval is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan. Furthermore, ONO also received an approval of Opdivo in combination with chemotherapy for the above same indication.
These approvals are based on results from the global multi-center, randomized, open-label Phase III CheckMate -648 study (ONO-4538-50/CA209648), evaluating Opdivo plus Yervoy and Opdivo plus chemotherapy, compared to chemotherapy alone in patients with previously untreated unresectable advanced or recurrent metastatic esophageal squamous cell carcinoma (ESCC). In this study, both Opdivo-based treatment combinations (Opdivo plus Yervoy and Opdivo plus chemotherapy) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to chemotherapy at the pre-specified interim analysis in patients with tumor cell PD-L1 expression greater than 1%, as well as in the all-randomized population. The safety profiles of Opdivo plus Yervoy and Opdivo plus chemotherapy were consistent with the known safety profiles of the individual components.
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