Nivolumab (9) – Opdivo®

• Clinical trials
  • The ongoing, single-arm Phase II trial CheckMate275 is being conducted at 63 centres worldwide.
  • CheckMate032 is another ongoing, open-label Phase I/II trial comparing nivolumab as monotherapy with the combination of nivolumab and ipilimumab.
  • In the Bellmunt 2009 study, an open-label, multicentre, randomised and controlled trial conducted between 2005 and 2008, vinflunine was compared with best supportive care.
  • The open-label, randomised and controlled Bellmunt 2017 study was designed to compare vinflunine with cabazitaxel.
  • The single-arm Vaughn 2009 study investigated overall survival, response rate and side effects in 151 patients treated with vinflunine.

Patients with early recurrence (≤ 6 months)

• The additional benefit is not proven.
• The pharmaceutical manufacturer does not present any results in the dossier from directly comparative studies or studies suitable for an adjusted indirect comparison.
• On the basis of the evidence submitted, it is not possible to make comparative statements regarding the additional benefit of nivolumab compared with the appropriate comparator therapy defined by the G-BA.
• mortality
  • No results suitable for a comparison of the therapies were submitted for the endpoint categories of morbidity and quality of life.
• morbidity
  • No results suitable for a comparison of the therapies were submitted for the endpoint categories of morbidity and quality of life.
• Health-related quality of life
  • No results were presented for the endpoint categories of morbidity and quality of life that are suitable for a comparison of the treatments.
• Side effects
  • In an unadjusted comparison of study results, only those differences of a magnitude such that it can be ruled out that they are due solely to systematic bias may be used to demonstrate additional benefit.
  • The immune-mediated side effects characteristic of the PD-L1 inhibitor class were not presented in a comparative manner by the pharmaceutical manufacturer, as results for vinflunin were not available.
  • With regard to the endpoint category of side effects, therefore, only incomplete results are available, which do not allow for a comprehensive comparison of the adverse events associated with nivolumab and vinflunin in their entirety.
  • Due to the incomplete data, the overall rates of adverse events are considered more relevant for the comparison to be made here than the specific side effects selected by the manufacturer.
  • No relevant differences in favour of nivolumab were observed, nor were there any differences that could be attributed with sufficient certainty to positive effects of nivolumab.
  • In particular, there is no significant difference between the interventions with regard to the overall rate of therapy discontinuation due to adverse events.

Courtesy translation only, please refer to the German original.