Mixed Phase III results for Lenvima plus Keytruda in HNSCC
An update on the Phase III LEAP-010 trial evaluating Eisai’s (TYO: 4523) Lenvima (lenvatinib) plus Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, was announced today.
The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
Two planned interim analyses were conducted by an independent Data Monitoring Committee (DMC) over an 11-month period. In the first analysis, Lenvima plus Keytruda showed a statistically-significant improvement in PFS and ORR versus placebo plus Keytruda, which is a mega-billion dollar seller for Merck.
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