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March 4, 2026Clinical Cancer Research0 citations

Pembrolizumab Monotherapy in Sorafenib-Treated and Treatment-Naive Advanced Hepatocellular Carcinoma: Long-Term Follow-Up of Open-Label, Phase 2 KEYNOTE-224 Study

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RFRichard S. FinnMKMasatoshi KudoIBIvan Borbath

Key Points

  • To evaluate the long-term efficacy and safety of pembrolizumab in patients with advanced hepatocellular carcinoma (HCC) who had or had not received prior treatment.
  • Conducted an open-label phase 2 trial (KEYNOTE-224)
  • Included participants with advanced HCC—both treatment-naive and those treated with sorafenib
  • Administered pembrolizumab monotherapy for ≤2 years
  • Followed all participants for long-term outcomes, especially overall survival (OS)
  • Pembrolizumab showed durable responses in advanced HCC
  • Some participants demonstrated sustained OS lasting beyond 48 months
  • The safety profile remained manageable throughout the follow-up period

Abstract

Pembrolizumab continued to show durable response and manageable safety in participants with advanced HCC with or without prior systemic therapy, with long-term effects on OS lasting beyond 48 months in some participants despite receiving study treatment for ≤2 years.

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Cite This Study

Finn et al. (2026) studied this question.

synapsesocial.com/papers/69a7cd6ed48f933b5eed9d1ahttps://doi.org/10.1158/1078-0432.ccr-25-3528
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