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Merck, Eisai discontinue late-stage study for liver cancer therapy

The LEAP-012 trial failed to improve overall survival for Keytruda and Lenvima in liver cancer despite prior progression-free survival gains, officials said.

  • MSD and Eisai said the LEAP-012 study ended after Keytruda and Lenvima failed to increase overall survival in hepatocellular carcinoma, halting their Western development push.
  • The LEAP-012 protocol compared Keytruda plus Lenvima against placebo atop transarterial chemoembolisation , with earlier progression-free survival gains raising hopes for unresectable, non-metastatic hepatocellular carcinoma .
  • Commercially, Lenvima is FDA-approved first-line for unresectable HCC, Keytruda is second-line, and MSD licensed Lenvima rights in a near-$6 billion 2018 deal.
  • The decision leaves Western markets with fewer options as China keeps LEAP-012 PFS-based approval, and earlier this week MSD reported Welireg trial wins with $1.5 billion potential.
  • Broader trial results suggest, despite LEAP-012 PFS gains and approvals, prior disappointments in other cancer indications temper expectations, said Eisai's Dr Corina Dutcus, `For years, TACE has been a standard of care for these patients, yet many experience disease progression within 12 months`.
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The Mighty 790 KFGO broke the news in on Wednesday, October 29, 2025.
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