Opdivo improves survival in unresectable HCC despite missing endpoint

Results from a phase 3 study of Opdivo for unresectable hepatocellular carcinoma revealed that the drug showed a trend toward improvement in overall survival but did not meet significance for its primary endpoint, according to a press release from Bristol-Myers Squibb.

The phase 3 CheckMate-459 included patients randomly assigned to receive either Opdivo (nivolumab, Bristol-Myers Squibb) or Nexavar (sorafenib, Bayer) as first-line treatment for unresectable HCC.

“We are encouraged by the promising efficacy and safety trends seen with Opdivo in CheckMate-459, especially as HCC is a devastating and difficult-to-treat cancer, for which there have been no significant advances over sorafenib, a standard treatment, in more than a decade,” Bruno Sangro, MD, head of the Liver Unit at the University Clinic of Navarra in Spain, said in the release.

Nivolumab is a programmed death-1 immune checkpoint inhibitor that is currently under investigation for multiple settings and lines of therapy for HCC including monotherapy and in combination with Yervoy (ipilimumab, Bristol-Myers Squibb) for treatment-experiecned patients.

“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,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb, said in the release.

The researchers noted no new safety signals with nivolumab during the trial.

Reference: www.bms.com