Bristol Myers Squibb's Opdivo plus Yervoy Receives NMPA Approval as First-Line Therapy for Unresectable or Advanced Hepatocellular Carcinoma in China

Mar 31, 2025 12:38 CST Updated 12:38

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Today (March 31), Bristol-Myers Squibb Company has just announced that itsThe combination therapy of two cancer immunotherapy drugs, Opdivo (Nivolumab Injection) and Yervoy (Ipilimumab Injection)Approved by the China National Medical Products Administration (NMPA) for an additional indication, applicable toFirst-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval is based on the Phase 3 CheckMate-9DW study, which globally demonstrated that the immunotherapy regimen for first-line treatment of hepatocellular carcinoma showed significantly superior efficacy compared to two previous standard-of-care drugs.

CheckMate-9DW2 is a global, multicenter, Phase 3 randomized controlled study that evaluated nivolumab.Efficacy and Safety of Pemigatinib vs. Investigator's Choice of Lenvatinib or Sorafenib in First-Line Treatment of Patients with Unresectable Hepatocellular Carcinoma, Where 85% of the Control Group Received Lenvatinib.

The main endpoint results of the study showed,Nivolumab CombinationIpilimumab GroupThe median overall survival (mOS) was 23.7 months (20.6 months in the control group), significantly reducing the risk of death by 21%.。Secondary endpoints,Nivolumab CombinationIpilimumab GroupThe objective response rate (ORR) was 36%, nearly three times the improvement compared to the control group (13%).；The median duration of response (mDOR) reached 30.4 months, which is more than twice the improvement compared to the control group (12.9 months).. In the study,Nivolumab CombinationThe overall safety of the ipilimumab regimen is controllable, with no new safety signals identified. The incidence of grade 3/4 treatment-related adverse events was 41% (42% in the control group).

Bristol-Myers Squibb press release introduced,Nivolumab CombinationThe efficacy advantage of the ipilimumab regimen is due to the highly synergistic mechanisms of the two drugs:CTLA-4 InhibitorIpilimumab mainly acts on the initiation and activation stages of T cells, promoting the activation and proliferation of T cells., its unique immune regulatory cell (Treg) clearance function can also help improve the immunosuppressive state of the liver cancer tumor microenvironment, further enhancing the immune anti-tumor effect; andPD-1 InhibitorNivolumab mainly acts on the effector phase of T cells, helping activated T cells recognize and kill tumor cells.. Based on a unique mechanism of action and clinical research evidence,Nivolumab CombinationThe ipilimumab regimen has been approved in China for multiple cancer types, including pleural mesothelioma, colorectal cancer, and hepatocellular carcinoma.

References:

[1]Opdivo® Combined with Yervoy® Becomes the Only Approved First-Line Dual Immunotherapy for Hepatocellular Carcinoma in China. Retrieved Mar 31，2025, from https://mp.weixin.qq.com/s/Fi7rKzz_fjmH6M_MWvCWSg

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