Although results from the final analysis showed that improved overall survival when compared with placebo, the differences did not reach statistical significance per predefined criteria (HR=0.781; 95% CI=0.611–0.998; p=0.0238).
← all excerpts
Current Status and Future Direction of Immunotherapy in Hepatocellular Carcinoma: What Do the Data Suggest?
3
0.0238
0.0750
The sentences
did not achieve significancep=0.075
Regrettably, the CheckMate 459 trial, a randomized phase III study evaluating nivolumab versus sorafenib as a first-line treatment in patients with unresectable HCC, did not achieve significance for its primary endpoint of overall survival as defined in the pre-specified analysis plan (hazard ratio [HR]=0.85; 95% CI=0.72–1.02; p=0.075) ( 34 ).
Although the results failed to meet the predefined threshold of statistical significance because p-value for overall survival of this trial is borderline, there was a clear trend suggestive of improved overall survival for patients treated with nivolumab compared to sorafenib.