Pembrolizumab (6) – Keytruda®

• Clinical trials
  • The pharmaceutical manufacturer submitted data from the open-label, randomised, controlled KEYNOTE 040 trial for the benefit assessment procedure, which compared pembrolizumab with a treatment of the clinician’s choice (selecting from methotrexate, cetuximab or docetaxel).

Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) with PD-L1-expressing tumours (TPS ≥ 50 per cent) and disease progression during or following prior platinum-based therapy

• The additional benefit is not proven.
• No data are available to enable an assessment of the additional benefit.
• The comparator therapy in the KEYNOTE 040 trial does not correspond to the appropriate comparator therapy (nivolumab) specified in this resolution, which is why the results submitted in the dossier for the benefit assessment, which are intended for direct comparison with the comparator therapy in the KEYNOTE 040 trial, do not allow for an assessment of the additional benefit of pembrolizumab.
• Morbidity – Progression-free survival
  • No data are available.
• Health-related quality of life – Health status (EQ-5D VAS)
  • No usable data.
• Summary of the assessment
  • Nivolumab was identified as the appropriate comparator therapy.
  • For the benefit assessment, the pharmaceutical manufacturer has submitted the results of the open-label, randomised, controlled KEYNOTE 040 trial, in which pembrolizumab was compared with a treatment of the clinician’s choice (selecting from methotrexate, cetuximab or docetaxel).
  • The comparator therapy in the KEYNOTE 040 study therefore does not correspond to the appropriate comparator therapy (nivolumab) specified in this resolution; consequently, the results submitted do not allow for an assessment of the additional benefit of pembrolizumab.
  • Consequently, it is concluded that the additional benefit of pembrolizumab is not proven.

Courtesy translation only, please refer to the German original.