Bristol Myers (BMY.US) extends life for liver cancer patients! Its frontline immunotherapy combo gets EU approval.

Bristol-Myers Squibb (BMY.US) announced that the European Commission (EC) has approved Opdivo (nivolumab), a key PD-1 inhibitor, in combination with Yervoy (ipilimumab), a targeted antibody against CTLA-4, for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). It is reported that the US FDA has accepted the supplemental biologics license application for Opdivo in combination with Yervoy for the same patient population, and the review is expected to be completed before April 21.

According to public information, Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses, using the body's own immune system to fight cancer. Yervoy targets CTLA-4. The CTLA-4 antibody enhances T cell activity to improve tumor killing ability.

Data showed that Opdivo in combination with Yervoy significantly prolonged the overall survival (OS) of patients, reaching the primary clinical endpoint of the trial. The median OS of the Opdivo plus Yervoy combination therapy group was 23.7 months (95% CI: 18.8–29.4), while that of the active control drug group was 20.6 months (95% CI: 17.5–22.5), with a risk ratio of 0.79 (0.65–0.96; p=0.018). The benefit of overall survival was generally consistent across patient subgroups.