Opdivo in CHECKMATE 459 trial versus sorafenib in hepatocellular carcinoma fails to achieve statistical significance for overall survival
Bristol-Myers Squibb Company announced topline results from CheckMate -459, a randomized Phase III study evaluating Opdivo (nivolumab) versus 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) 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.
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 Yervoy cohort of CheckMate -040 were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019.
About CheckMate -459 ; CheckMate -459 was a Phase III 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.
Comment: Opdivo received Accelerated Approval from the FDA to treat hepatocellular carcinoma ( liver cancer) in September 2017.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
4 mins