Nivolumab (29) – Opdivo®

• Clinical trials
  • The CA209-8HW trial is an open-label, three-arm, randomised controlled trial that began in 2019 and is currently ongoing, comparing nivolumab in combination with nivolumab versus nivolumab versus chemotherapy as determined by the treating physician.
  • The KEYNOTE 177 trial is a completed, open-label, randomised controlled trial comparing pembrolizumab with chemotherapy as determined by the treating physician.

Adults with unresectable or metastatic colorectal cancer with mismatch repair deficiency or high microsatellite instability; first-line treatment

• The additional benefit is not proven.
• Consequently, there are no data available in the overall review that would allow an assessment of the additional benefit.
• Overall review
  • A key prerequisite for including studies in an adjusted indirect comparison via a bridge comparator is the similarity of the studies. In this regard, there are significant differences between the CA209-8HW and KEYNOTE 177 studies with respect to the testing of MSI-H and dMMR status.
  • Consequently, against the backdrop of a result that is only just statistically significant, the data on overall survival are not suitable for drawing conclusions regarding additional benefit.
  • Given the central importance of overall survival data in this therapeutic indication and for demonstrating additional benefit through indirect comparisons, and taking into account the limited data available on patient-relevant endpoints, the adjusted indirect comparison is, on the whole, assessed as unsuitable for drawing conclusions regarding additional benefit.

Courtesy translation only, please refer to the German original.