The Absolute Effect / Evidence
KEYNOTE-394
Clinical question: In second-line pembrolizumab in asian patients after sorafenib/oxaliplatin-based chemotherapy, what is the efficacy and safety of the evaluated intervention?
Registry: NCT03062358 · One underlying study; aliases and follow-up publications consolidated.
Phase III, double-blind, placebo-controlled RCT; 453 Asian patients. Evidence cut-off: 13 November 2026.
Design, population and eligibility
Phase III, double-blind, placebo-controlled RCT; 453 Asian patients.
Advanced HCC previously treated with sorafenib or oxaliplatin-based chemotherapy.
Pembrolizumab versus placebo, both with best supportive care.
Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles.
placebo, both with best supportive care.
Primary endpoint: OS primary; PFS and ORR secondary.
Key efficacy outcomes
Median OS 14.6 vs 13.0 months, HR 0.79 (95% CI 0.63–0.99), p=0.018. PFS 2.6 vs 2.3 months, HR 0.74 (0.60–0.92); ORR 12.7% vs 1.3%.
Comparator: 13.0. The bars are a simple display of the first reported pair only; consult the endpoint and time horizon above.
Safety and treatment delivery
Pembrolizumab TRAEs grade 3 12.0%, grade 4 1.3%, grade 5 1.0%; placebo grade 3 5.9%, no grade 4/5 TRAEs.
Clinical interpretation and limitations
Interpret the reported hazard ratios in the context of the prespecified endpoint, statistical hierarchy, follow-up maturity, crossover/subsequent therapy and enrolled population. Median survival differences are not risk differences and must not be converted into NNT.
Absolute effect
No NNT/NNH is displayed unless an absolute event-risk difference at a clearly stated fixed timepoint can be calculated from reported trial data. Median survival differences and hazard ratios alone do not support an NNT. The visual above uses reported outcome data only.
Primary publication and follow-up
Registry / follow-up / authoritative source
Source-level verification status: primary publication identified and key quoted outcomes transcribed; where full-text toxicity or procedural details were not available, the page explicitly flags the limitation rather than inferring values.
Current-practice context · 13 November 2026
This page separates historical trial results from contemporary practice. Verify the applicable jurisdictional guideline, regulatory approval, biomarker assay, liver function, comorbidity and treatment availability before applying the evidence. NCCN Guidelines Insights are not a substitute for the full NCCN guideline.
Guideline/regulatory reconciliation and browser-rendered QA remain scheduled for the subsequent quality-control pass.