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Cancer research

Lenvatinib Plus Pembrolizumab Fails to Improve Efficacy in Stage IV NSCLC Patients

Strategic Insights

— 2 min read

Researchers from Princess Margaret Cancer Centre have published the results of a phase 3 study, LEAP-008, investigating the efficacy of lenvatinib plus pembrolizumab versus docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) that had progressed on anti-programmed cell death protein 1 or anti-programmed cell death ligand 1 therapy and platinum-containing chemotherapy. The study found that lenvatinib plus pembrolizumab did not improve overall survival or progression-free survival compared to docetaxel, and the rates of treatment-related adverse events were similar between the two treatment arms.

Key Takeaways:

  • The LEAP-008 study was a phase 3, open-label, randomized trial that enrolled 422 patients with metastatic NSCLC who had progressed on previous therapies.
  • Patients were randomized to receive either lenvatinib plus pembrolizumab (n = 185), docetaxel (n = 189), or lenvatinib monotherapy (n = 48).
  • The primary end points were overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 by central review.
  • The median PFS was 5.6 months with lenvatinib plus pembrolizumab and 4.2 months with docetaxel (hazard ratio, 0.89; p = 0.164).
  • The median OS was 11.3 months with lenvatinib plus pembrolizumab and 12.0 months with docetaxel (hazard ratio, 0.98; p = 0.434).
  • Rates of treatment-related adverse events were 91.7%, 91.0%, and 89.4% with lenvatinib plus pembrolizumab, docetaxel, and lenvatinib, respectively.
  • The study concluded that more effective therapies are needed for patients with stage IV NSCLC who have progressed on previous therapies.

Statistics:

  • 422 patients were enrolled in the LEAP-008 study.
  • 185 patients received lenvatinib plus pembrolizumab, 189 patients received docetaxel, and 48 patients received lenvatinib monotherapy.
  • The median PFS was 5.6 months with lenvatinib plus pembrolizumab and 4.2 months with docetaxel.
  • The median OS was 11.3 months with lenvatinib plus pembrolizumab and 12.0 months with docetaxel.
  • Rates of treatment-related adverse events were 91.7%, 91.0%, and 89.4% with lenvatinib plus pembrolizumab, docetaxel, and lenvatinib, respectively.

Sources:

  • NewsRx. Research Conducted at Princess Margaret Cancer Centre Has Updated Our Knowledge about Monoclonal Antibodies (LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-Programmed Cell Death Protein 1 or ...). Immunotherapy Weekly. August 27, 2025; p 2644.
  • LEAP-008: Lenvatinib Plus Pembrolizumab for Metastatic NSCLC That Has Progressed After an Anti-Programmed Cell Death Protein 1 or Anti-Programmed Cell Death Ligand 1 Plus Platinum Chemotherapy. Journal of Thoracic Oncology, 2025.

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