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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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Merck, Eisai discontinue late-stage study for liver cancer therapy
Merck and Japan's Eisai said on Wednesday they will shut down a late-stage study testing an experimental combination therapy to treat a type of liver cancer, after interim results showed the treatment was unlikely to improve overall survival.
·United Kingdom
Read Full ArticleMSD and Eisai to end Phase III LEAP-012 trial for unresectable HCC
MSD and Eisai are set to discontinue their Phase III clinical trial for unresectable, non‑metastatic HCC as Keytruda plus Lenvima, along with TACE, failed to achieve statistical significance for OS.The post MSD and Eisai to end Phase III LEAP-012 trial for unresectable HCC appeared first on Clinical Trials Arena.
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Leaning Left0Leaning Right1Center5Last UpdatedBias Distribution83%  Center
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R 17%
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