Pembrolizumab (Keytruda®) as first-line therapy for PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (NSCLC)

McGahan L
Record ID 32018000363
English
Authors' results and conclusions: KEYNOTE-042, an ongoing, randomised, open-label, phase III trial compared the efficacy and safety of pembrolizumab (200 mg IV; every three weeks up to 35 cycles) versus platinum-based chemotherapy (carboplatin + paclitaxel or pemetrexed; up to six cycles) as first-line therapy for 1,274 patients with PD-L1-expressing metastatic NSCLC. Overall, first-line pembrolizumab monotherapy increases OS for patients with programmed death ligand (PD-L1)-expressing metastatic NSCLC. Comprising 46.6% of the ITT population, the greatest overall survival (OS) benefit of pembrolizumab over chemotherapy was observed in patients with PD-L1 tumour proportion scores (TPS) ≥50%. No statistically significant difference in OS was noted between groups for those with PD-L1 TPS 1–49%; and no statistically significant differences in progression-free survival (PFS) or overall response rate (ORR) were noted in any PD-L1 TPS population. Data regarding quality of life (QoL) and CNS activity are needed to ensure patients derive a clinically relevant benefit over time despite manageable toxicity. Further biomarkers are needed to ensure the appropriate patient selection and facilitate comparison with other immune checkpoint inhibitors. In the absence of direct comparison trials, physicians may need to discuss whether adding pembrolizumab to chemotherapy would provide greater individual efficacy than chemotherapy alone, especially for PD-L1 TPS 1–49% patients.
Details
Project Status: Completed
URL for project: https://aihta.at/page/horizon-scanning-in-der-onkologie/en
Year Published: 2019
URL for published report: https://aihta.at/page/horizon-scanning-in-der-onkologie/en
URL for additional information: http://eprints.aihta.at/1219/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Lung Neoplasms
  • Therapeutics
  • Pharmacology
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Immunological
  • Carcinoma, Non-Small-Cell Lung
  • Survival Analysis
  • Treatment Outcome
Keywords
  • Pembrolizumab
  • Keytruda
  • non-small cell lung cancer (NSCLC)
  • metastatic
  • monoclonal antibody
  • first-line therapy
  • KEYNOTE-042
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
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.