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March 14, 2026Journal of Clinical Oncology

Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study

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Authors

LLLisa LicitraMTMakoto TaharaKHKevin Harrington

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Overview

Phase III trial shows lenvatinib with pembrolizumab improves outcomes in recurrent head and neck cancer, suggesting effective treatment options.

Key Points

  • Evaluate the effectiveness of lenvatinib combined with pembrolizumab as first-line therapy in R/M HNSCC.
  • Phase III, randomized, placebo-controlled, double-blind trial
  • Participants aged 18 or older with PD-L1 CPS ≥1 R/M HNSCC
  • Assigned to lenvatinib plus pembrolizumab or placebo plus pembrolizumab
  • Primary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS)
  • Median PFS at IA1 was 6.2 months for lenvatinib plus pembrolizumab versus 2.8 months for placebo plus pembrolizumab (HR 0.64)
  • ORR was 46.1% for lenvatinib plus pembrolizumab vs 25.4% for placebo plus pembrolizumab
  • Median OS at IA2 was 15.0 months for lenvatinib plus pembrolizumab versus 17.9 months for placebo (HR 1.15)
  • Higher grade 3-4 adverse events observed in the lenvatinib plus pembrolizumab group (66.9% vs 38.3%)

Cite This Study

Licitra et al. (2026) studied this question.

synapsesocial.com/papers/69b4fbf9b39f7826a300c7bchttps://doi.org/10.1200/jco-25-00570
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results From the Phase 2 LEAP-005 Study2026 · 4 citations
  2. 2Safety and efficacy of pembrolizumab plus lenvatinib as first-line therapy in non-small cell lung cancer: A systematic review and meta-analysis of randomized controlled trials.2026
  3. 3Lenvatinib plus pembrolizumab for patients with previously treated select solid tumors: Results from the phase 2 LEAP‐005 study recurrent glioblastoma cohort2025 · 4 citations
  4. 4Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple‐negative breast cancer: Results from the triple‐negative breast cancer cohort of the phase 2 LEAP‐005 Study2024 · 12 citations
  5. 5Pembrolizumab plus nab-paclitaxel and platinum as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A prospective, single-arm, open-label, phase 2 study.2024 · 2 citations