Nivolumab (28) – Opdivo®

• Clinical trials
  • The pharmaceutical manufacturer has submitted the results of the randomised, open-label Phase III trial CA209-901 (CheckMate 901) to demonstrate the additional benefit.
  • Of the four-arm trial, only the two treatment arms in which nivolumab + cisplatin + gemcitabine was compared with cisplatin + gemcitabine were relevant to this benefit assessment.

Adults with unresectable or metastatic urothelial carcinoma; first-line treatment

• The additional benefit is not proven.
• Consequently, the G-BA concludes that an additional benefit is not proven for nivolumab in combination with cisplatin and gemcitabine in the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
• In the CheckMate 901 trial, approximately 50 per cent of patients in the control arm receiving cisplatin + gemcitabine were not adequately treated with avelumab, despite being eligible for maintenance therapy with avelumab; consequently, the appropriate comparator therapy was not implemented for a significant proportion of patients.
• Consequently, no evaluable data are available for the benefit assessment.

Courtesy translation only, please refer to the German original.