Bristol-Myers Squibb’s Phase 3 CheckMate-459 Trial Fails to Meet Endpoints in Front-Line Liver Cancer

Jun 28, 2019 | Challenging Results, Immunotherapy for Cancer, Liver Cancer

Liver Cancer

Bristol-Myers Squibb announced topline results from CheckMate -459, a Phase 3 study evaluating Opdivo (nivolumab) versus Bayer’s Nexavar (sorafenib) as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC). The trial did not achieve statistical significance for its primary endpoint of overall survival (OS) compared to Nexavar.

While CheckMate -459 did not reach its pre-specified primary endpoint, the results showed a “clear trend” towards improvement in OS for patients treated with Opdivo compared to Nexavar. Bayer’s drug has been the standard of care in the front-line treatment of liver cancer since 2007, when the U.S. FDA granted approval. The full study results from CheckMate -459 will be presented at an upcoming medical meeting.

Opdivo is currently being studied across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting (CheckMate -9DX) and in combination with Yervoy (ipilimumab) for previously treated patients (CheckMate -040). Data from the Opdivo plus Yervoy cohort of CheckMate -040 were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019.

The U.S. FDA granted accelerated approval to Opdivo in 2017 for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.


About Hepatocellular Carcinoma

Liver cancer is the fourth most frequent cause of cancer death worldwide and hepatocellular carcinoma (HCC), the most common type of liver cancer, is the fastest rising cause of cancer-related death in the United States. HCC is often diagnosed in the advanced stage, where effective treatment options are limited and the survival benefit provided by the first-line standard of care is less than three months over placebo.

About Opdivo (nivolumab)

Opdivo (nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. Opdivo has been approved as a single agent and in combination with Yervoy (ipilimumab) for several indications, including melanoma, non-small cell lung cancer, small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck cancer and urothelial carcinoma.


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