BMS’ Opdivo disappoints in late-stage trial

Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical significance for its primary endpoint of overall survival. The news isn’t all negative, however, as a clear trend was demonstrated towards improvement in overall survival for patients treated with Opdivo compared Nexavar. The drug is currently being studied by the company across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting and in combination with Yervoy (ipilimumab) for previously treated patients. The company say that they are still “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,” said Bruno Sangro, head of the Liver Unit, Clínica Universidad de Navarra. Ian Waxman, development lead, Gastrointestinal Cancers BMS also commented that the company will “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.���