Bristol-Myers Squibb’s (BMS) CheckMate -459 Phase III clinical trial of Opdivo (nivolumab) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) has failed to meet the primary endpoint of overall survival (OS).

The randomised, multi-centre Phase III study is evaluating Opdivo versus sorafenib as a first-line treatment for HCC, the most common type of liver cancer. No new safety signals were observed with Opdivo in the trial.

BMS noted that the results showed a clear trend towards improvement in OS for patients treated with Opdivo compared to sorafenib.

Bristol-Myers Squibb Gastrointestinal Cancers development lead Ian Waxman said: “We remain confident in the important role of Opdivo for the treatment of patients with HCC and look forward to evaluating insights garnered from this trial with the goal of ensuring patients with liver cancer have the opportunity to achieve the best possible outcomes.”

As part of Opdivo’s clinical programme, BMS is studying it across multiple settings and lines of therapy for HCC, including as a monotherapy in the adjuvant setting and in combination with Yervoy (ipilimumab) for patients who received treatment earlier.

In the CheckMate -459 trial, patients with HCC were treated until disease progression or unacceptable toxicity.

Secondary endpoints of the trial included overall response rate, progression-free survival, and the relationship between tumour PD-L1 expression and efficacy.

The programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo will harness the body’s own immune system to help restore anti-tumour immune response to fight cancer.

In May this year, BMS’ Phase III CheckMate -498 study failed to meet the primary endpoint of OS with Opdivo plus radiation in patients with newly diagnosed MGMT-Unmethylated Glioblastoma Multiforme.