Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer

Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
Record ID 32016000488
English
Authors' recommendations: Nivolumab is the first immunotherapy medicine licensed in the European Union for the treatment of squamous-cell non-small cell lung cancer (NSCLC). Based on the findings of the CheckMate 017 trial, nivolumab received market authorisation for previously treated patients with squamous NSCLC in July 2015. This open-label phase III study compared nivolumab with docetaxel in a total of 272 patients with squamous-cell NSCLC who had previously been treated with one platinum-containing regimen Median. Overall survival (the primary outcome of this phase III trial) was increased by 3.2 months in the nivolumab group in comparison to the docetaxel group, resulting in a reduction of risk of death by 41%. With 38%, the risk of progression or death was also statistically lower, leading to a gain in median progression-free survival by 0.7 months. Duration of response was not yet reached in the nivolumab group and was 8.4 months in the docetaxel group. Response rates also favoured the PD-L1 inhibitor (20% vs 9%), with the majority being partial responses (19% vs 9%). In terms of safety outcomes, treatment-related adverse events (AEs) were less frequent in the nivolumab group than in the chemotherapy group. Any-grade AEs occurred in 58% in the nivolumab group in comparison to 86% in the docetaxel group, and grade 3 or 4 AEs in 7% and 55% respectively. Overall, improved outcomes in all assessed endpoints were demonstrated in the CheckMate 017 trial, with fewer AEs in comparison to standard second-line chemotherapy. Nonetheless, high costs are incurred, data for patient-reported outcomes have not been published yet and long-term adverse effects of immune therapies are unknown.
Details
Project Status: Completed
URL for project: http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie
Year Published: 2015
URL for published report: http://eprints.hta.lbg.ac.at/1068
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Austria
MeSH Terms
  • Nivolumab
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Immunological
  • Immune Checkpoint Inhibitors
Contact
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
Contact Name: tarquin.mittermayr@aihta.at
Contact Email: office@aihta.at
Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
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