🔬 Merck, Eisai halt HCC combo trial after OS miss

Merck & Co. and Eisai have stopped the Phase III LEAP-012 trial in unresectable, non-metastatic HCC after Keytruda plus Lenvima failed to improve overall survival over TACE, despite prior PFS gains reported at ESMO and in The Lancet.

Why It Matters To Oncology

▪ The combo showed a 34% PFS risk reduction but did not extend OS, the gold-standard endpoint for drug approval and clinical adoption in HCC.

▪ LEAP-012's failure follows similar setbacks in the LEAP-002 and LEAP-015 trials, raising doubts about broadening the combos use beyond renal and endometrial cancers.

The Financials

▪ Lenvima's HCC market growth prospects dim, potentially impacting Eisai's revenue stream and Keytruda's expansion strategy for Merck.

▪ Both drugs remain approved for renal cell carcinoma and certain endometrial tumors in the US.

What They're Saying

▪ "Lenvima continues to play an important role as a monotherapy treatment option for patients with unresectable HCC," said Eisai's Corina Dutcus.

▪ Companies acknowledge the low likelihood of achieving statistical OS benefit on further analysis.

What's Next

▪ Further analyses of LEAP-012 are ongoing; full data will be shared with the scientific community.

▪ Drug development focus likely to shift to identifying more effective combinations or biomarker-driven approaches in HCC.