Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of metastatic non-small-cell lung cancer (NSCLC)

McGahan L
Record ID 32018000326
Authors' results and conclusions: In the phase III, KEYNOTE-189 study, 616 patients with untreated metastatic non-squamous Non-small cell lung cancer (NSCLC) without targetable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) aberrations -regardless of programmed death ligand (PD-L1) expression- were randomised 2:1 to pemetrexed and platinum-based chemotherapy plus either pembrolizumab or saline placebo every three weeks for four cycles, followed by pembrolizumab or placebo for 35 cycles plus pemetrexed maintenance therapy. Overall, adding pembrolizumab to platinum-based chemotherapy increases overall survival (OS), progression-free survival (PFS), and overall response rate (ORR), and reduces the risk of death and progression for patients with metastatic NSCLC. While the survival benefit of pembrolizumab combination over chemotherapy alone was observed regardless of PD-L1 tumour expression, the greatest relative benefit was achieved in patients whose tumours exhibited higher PD-L1 levels. Due to possible cross-overs (to the intervention grup), only relative 12 month OS data are available; absolute OS data are not (and will not) be available.
Authors' recomendations: Data regarding quality of life and central nervous system activity are needed to ensure patients derive a clinically relevant benefit over time despite manageable toxicity. Without direct comparison trials, physicians may need to discuss whether adding pembrolizumab to platinum-based chemotherapy would provide patients with greater individualised efficacy than pembrolizumab monotherapy.
Project Status: Completed
Year Published: 2018
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English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Therapeutics
  • Pharmacology
  • Lung Neoplasms
  • Antibodies, Monoclonal
  • Carcinoma, Non-Small-Cell Lung
  • Drug Therapy
  • Non-small-cell lung cancer
  • metastatic NSCLC
  • pembrolizumab
  • Keytruda┬«
  • monoclonal antibody
  • platinum-based chemotherapy
Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
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