Duvelisib (2) – Copiktra®

• Clinical trials
  • For the benefit assessment, the pharmaceutical manufacturer submitted the results of the multicentre, open-label, single-arm DYNAMO (IPI-145-06) for the treatment of adults with follicular lymphoma refractory to at least two previous systemic therapies.

Adults with follicular lymphoma that is refractory to at least two previous systemic therapies

• An additional benefit is not proven.
• Overall, the results submitted from the DYNAMO study are not suitable for demonstrating additional benefit compared with the appropriate comparator therapy, as they do not allow for a comparison with the appropriate comparator therapy.
• Consequently, additional benefit from duvelisib as monotherapy in adult patients with follicular lymphoma that is refractory to at least two previous systemic therapies is not proven.
• mortality
  • Further endpoints included overall survival [...]
• Conclusion
  • Overall, the results presented from the DYNAMO study are not sufficient to demonstrate additional benefit over the appropriate comparator therapy, as they do not allow for a comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.