▎WuXiEdited by Kant Content Team

Bristol Myers Squibb today announced that the European Commission (EC) hasApproved its重磅PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 targeted antibody Yervoy (ipilimumab) for first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).

The EU approval was mainly based on the positive results of the Phase 3 clinical trial CheckMate-9DW. This is a Phase 3 randomized, open-label trial evaluating the efficacy and safety of Opdivo in combination with Yervoy compared to investigator's choice of sorafenib or lenvatinib monotherapy for the treatment of patients with advanced HCC who have not received prior systemic therapy.

Data show that treatment with Opdivo combined with Yervoy significantly extended patients' overall survival (OS), achieving the primary clinical endpoint of the trial.The median OS for patients in the Opdivo plus Yervoy combination therapy group was 23.7 months (95% CI: 18.8–29.4), compared to 20.6 months (95% CI: 17.5–22.5) for patients in the active comparator group, with a hazard ratio of 0.79 (0.65–0.96; p=0.018).The overall survival benefit was generally consistent across patient subgroups.

In addition, the combination therapy also significantly improved the key secondary endpoint overall response rate (ORR),The ORR for patients receiving the Opdivo plus Yervoy combination therapy was 36.1% (95% CI: 31-41.5), compared to 13.2% (95% CI: 9.8-17.3, p<0.0001) for those receiving active comparator drugs.

The U.S. FDA has accepted the supplemental Biologics License Application for Opdivo in combination with Yervoy for the same patient population, with a decision expected by April 21 this year.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses by utilizing the body's own immune system to fight cancer. Yervoy, on the other hand, targets and inhibits CTLA-4. CTLA-4 antibodies enhance tumor-killing ability by boosting T-cell activity.This product was approved by the U.S. FDA in 2011 for the treatment of advanced melanoma and is the world's first approved CTLA-4 antibody drug.

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