O药大败局：Nivolumab 一线肝癌不敌索拉非尼！

CheckMate -459失败。O药大败局：Nivolumab 一线肝癌不敌索拉非尼！

June 24, 2019 06:59 AM Eastern Daylight Time

PRINCETON, N.J.--Bristol-Myers Squibb Company (NYSE:BMY) today announced topline results from CheckMate -459, a randomized Phase 3 study evaluating Opdivo (nivolumab) versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma (HCC). （不可切除肝细胞癌）The trial did not achieve statistical significance for its primary endpoint of overall survival (OS) per the pre-specified analysis (HR=0.85 [95% CI: 0.72-1.02]; p=0.0752). No new safety signals were observed with Opdivo. The full study results will be presented at an upcoming medical meeting.

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 sorafenib, a current standard of care.

“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,” said Bruno Sangro, M.D., head of the Liver Unit, Clínica Universidad de Navarra, Pamplona, Spain.

Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb, commented, “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.”

As part of its broad clinical program, Opdivo is being studied by the company across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting (CheckMate -9DX [NCT03383458]) and in combination with Yervoy (ipilimumab) for previously treated patients (CheckMate -040 [NCT01658878]). Data from the Opdivo plus Yervoycohort of CheckMate -040 were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019. Bristol-Myers Squibb is grateful to the patients, caregivers and investigators involved in our clinical research program.

About CheckMate -459

CheckMate -459 was a Phase 3 randomized, multi-center study evaluating Opdivo versus sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma. Patients were treated until disease progression or unacceptable toxicity. The primary endpoint of the trial was overall survival. Secondary endpoints included overall response rate, progression-free survival and the relationship between tumor PD-L1 expression and efficacy.

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. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.