Bristol-Myers Squibb’s efforts to increase treatment indications for its immunotherapy blockbuster, Opdivo, have hit a bump in the road.
According to the company, a phase 3 study of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer, failed to meet its primary endpoint of overall survival (OS). BMS also admitted that “no new safety signals were observed.”
The trial, dubbed CheckMate -459 compared Opdivo to Bayer’s Nexavar (sorafenib), which was approved to treat HCC in 2008. Although the study did not hit its intended target, BMS said that the data showed “a clear trend toward improvement in OS for patients treated with Opdivo compared to sorafenib, the current standard of care.”
Sales for Opdivo, which is currently approved for several types of tough-to-treat cancers including advanced non-small cell lung cancer, classical Hodgkin’s lymphoma and more, reached $6.74 billion last year and remains the company’s best-selling drug.
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