Opdivo® IV Infusion Approved in Taiwan in Combination with Yervoy® for Unresectable or Metastatic 1L HCC
This approval is based on the results from the CheckMate -9DW study, a global multi-center Phase 3 clinical study (CA209-9DW: ONO-4538-92), evaluating Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic anti-cancer therapy. In this study, in which 85% of patients in the comparator arm were treated with lenvatinib and 15% were treated with sorafenib, Opdivo plus Yervoy met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful improvement in OS compared to lenvatinib or sorafenib monotherapy. The median OS with Opdivo plus Yervoy (n=335) was 23.7 months (95% CI: 18.8-29.4) vs. 20.6 months (95% CI: 17.5-22.5) with lenvatinib or sorafenib (n=333; HR=0.79; 95% CI: 0.65-0.96 P=0.018), reducing the risk of death by 21%.1) The safety profile of Opdivo plus Yervoy was consistent with previously reported data, with no new safety signals identified.
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