Pembrolizumab (Keytruda®) in previously treated advanced non-small cell lung cancer (NSCLC)

Baumann M, Groessmann N
Record ID 32016000583
English
Authors' recommendations: The FDA granted pembrolizumab accelerated approval and the breakthrough status for the new indication non-small cell lung cancer (NSCLC) in October 2015, based on KEYNOTE-001. This phase Ib-study delivered evidence supporting the efficacy and tolerability of the therapy in previously treated patients with advanced and PD-L1 expressing NSCLC. KEYNOTE-010, a randomised, open-label phase III trial reports efficacy and adverse events (AEs) of pembrolizumab (in two different dosages) in comparison to docetaxel. Generalisability of the results could be compromised due to the stringent inclusion criteria of ECOG-performance 0/1 and the relatively young median age (63 years) of the studied population. Open questions remain regarding the combination with other therapeutics and the comparison with other targeted therapies such as nivolumab. In addition, the benefit for patients with EGFR mutation needs to be further examined. Data for quality of life are still missing. Overall, KEYNOTE-010 reported a significantly improved OS with fewer side-effects compared to the chemotherapeutic docetaxel. Evidence is however still relatively scarce when it comes to patient related outcomes as well as long term effects, and to identify those patients who benefit most from pembrolizumab remains a challenge.
Details
Project Status: Completed
URL for project: http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie
Year Published: 2016
URL for published report: http://eprints.hta.lbg.ac.at/1086/1/DSD_HSO_Nr.58.pdf
URL for additional information: http://eprints.hta.lbg.ac.at/1086/
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Austria
MeSH Terms
  • Antineoplastic Agents, Immunological
  • Antibodies, Monoclonal, Humanized
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • 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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