Merck/Eisai's Cancer Combo Therapy Ambition Dashed Once Again, Companies Throw Towel On Head & Neck Trial

Merck & Co Inc MRK and Eisai Ltd ESALY provided an update on the Phase 3 LEAP-010 trial evaluating Keytruda (pembrolizumab), plus Lenvima for recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1. 

An independent Data Monitoring Committee conducted two planned interim analyses over 11 months. 

In the first analysis, Keytruda plus Lenvima showed a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) versus Keytruda plus placebo. 

At the second analysis, Keytruda Lenvima did not demonstrate an improvement in overall survival (OS) compared to Keytruda plus placebo, and the likelihood of reaching the protocol-specified threshold for statistical significance for OS was evaluated by Merck and Eisai and deemed to be low. 

Accordingly, the Phase 3 LEAP-010 study will be closed. A full evaluation of the data from this study, including pre-planned subgroup analyses, is ongoing. 

In April, the Phase 3 LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of OS for unresectable and metastatic colorectal cancer that is mismatch repair proficient or not microsatellite instability-high who experienced disease progression on or became intolerant to, prior therapy. 

The companies also discontinued the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma.

Last year, the Phase 3 LEAP-002 trial of Keytruda plus Lenvima did not meet its dual primary endpoints of OS and PFS in unresectable hepatocellular carcinoma. 

Price Action: MRK shares are up 0.36% at $109.84 on the last check Friday