Bristol-Myers Squibb announced Monday that a Phase III study of Opdivo (nivolumab) versus Bayer's Nexavar (sorafenib) as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC) failed to meet its primary endpoint of overall survival (OS). Full trial results are slated for presentation at an upcoming medical meeting.
In the CheckMate -459 study, patients with unresectable HCC were randomised to receive either Opdivo or Nexavar as a first-line treatment until disease progression or unacceptable toxicity. In addition to the main goal of OS, the secondary endpoints included progression-free survival, overall response rate, survival and the relationship between tumour PD-L1 expression and efficacy.
According to Bristol-Myers Squibb, while the trial missed its primary endpoint, top-line results showed that there was "a clear trend towards improvement" in OS for patients treated with Opdivo compared to Nexavar. Commenting on the findings, Ian Waxman, Bristol-Myers Squibb's development lead for gastrointestinal cancers, stated "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."
Opdivo was granted accelerated FDA approval in 2017 for the treatment of HCC in patients who were previously treated with Nexavar. Sales of the anti-PD-1 therapy rose 19% year-on-year in the first quarter to $1.8 billion (for additional analysis, see ViewPoints: Key takeaways from Bristol-Myers Squibb's Q1 earnings and investor call.
The negative study results, along with news that Bristol-Myers Squibb plans to divest Otezla (apremilast) in order to satisfy concerns expressed by the US Federal Trade Commission regarding its proposed $74-billion acquisition of Celgene, sent shares in the former down as much as 7% on Monday.
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