Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study - PubMed
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- #Clinical trial
- #Head and neck cancer
- #Immunotherapy
- Pembrolizumab with or without lenvatinib was evaluated as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the LEAP-010 study.
- The study was a phase III, randomized, placebo-controlled, double-blind trial involving 511 participants with PD-L1 CPS ≥1 R/M HNSCC.
- Participants received either lenvatinib plus pembrolizumab or placebo plus pembrolizumab for up to 35 cycles.
- Primary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
- At the first interim analysis, lenvatinib plus pembrolizumab showed a median PFS of 6.2 months vs. 2.8 months for placebo plus pembrolizumab (HR 0.64).
- ORR was significantly higher in the lenvatinib plus pembrolizumab group (46.1%) compared to the placebo group (25.4%).
- At the second interim analysis, median OS was 15.0 months for lenvatinib plus pembrolizumab vs. 17.9 months for placebo plus pembrolizumab (HR 1.15).
- Grade 3-4 adverse events were more common in the lenvatinib plus pembrolizumab group (66.9%) compared to the placebo group (38.3%).
- The combination improved ORR and PFS but not OS, with a safety profile consistent with published data.