Futibatinib (1) – Lytgobi®

• Clinical trials
  • The FOENIX-CCA2 trial is a single-arm, open-label, multicentre Phase I/II trial investigating the efficacy and safety of futibatinib.
  • The FIGHT-202 trial is a single-arm, open-label, multicentre Phase II trial designed to investigate the efficacy and safety of pemigatinib in adults with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or -rearrangements, who have previously received treatment and have experienced disease progression.

Adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or FGFR2 rearrangement; following at least one prior line of systemic therapy

• The additional benefit is not proven.
• Therefore, the additional benefit of futibatinib as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or FGFR2 rearrangement, which has progressed following at least one prior line of systemic therapy, proof is not proven.
• To assess the additional benefit of futibatinib, the pharmaceutical manufacturer drew on the results of the single-arm FOENIX-CCA2 trial.
• The results of the single-arm study are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
• For an indirect comparison of treatment with futibatinib versus pemigatinib, the pharmaceutical manufacturer submitted a naive comparison as well as MAIC analyses without a bridge comparator for individual arms, based on the FOENIX-CCA2 and FIGHT-202 studies.
• MAIC analyses without a bridge comparator are not regarded as an adequate method of adjusting for confounders.
• Furthermore, conducting MAIC analyses for only one endpoint (in this case, overall survival) is also considered inappropriate.

Courtesy translation only, please refer to the German original.