publication date: Jun. 28, 2019
CheckMate-459 results for Opdivo don’t meet OS endpoint in hepatocellular carcinoma
Bristol-Myers Squibb Co. announced topline results from CheckMate-459, randomized phase III study evaluating Opdivo (nivolumab) vs. sorafenib as a first-line treatment in patients with unresectable hepatocellular carcinoma.
The trial did not achieve statistical significance for its primary endpoint of overall survival 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, the company said.
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, the company said.
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.
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 Annual Meeting 2019.
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