Progression-Free Survival in Patients With Cholangiocarcinoma With or Without <i>FGF/FGFR</i> Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response.

Abstract

Oncogenic fibroblast growth factor receptor (FGFR) gene alterations have been described in patients with cholangiocarcinoma (CCA). This post hoc analysis assessed progression-free survival (PFS) in patients who had received first- or second-line systemic therapy for advanced/metastatic CCA before enrollment in the phase II FIGHT-202 study (ClinicalTrials.gov identifier: NCT02924376). Patients with locally advanced or metastatic CCA with <i>FGFR2</i> fusions/rearrangements (n = 107), other <i>FGF/FGFR</i> alterations (n = 20), or no <i>FGF/FGFR</i> alterations (n = 18) and documented disease progression after at least one systemic cancer therapy before enrollment in FIGHT-202 were assessed. Prior therapy and disease response data were collated from electronic case report forms. PFS was calculated for each prior line of systemic cancer therapy. Among patients with <i>FGFR2</i> fusions/rearrangements, other <i>FGF</i>/<i>FGFR</i> alterations, and no <i>FGF</i>/<i>FGFR</i> alterations, respectively, the median PFS with prior first-line systemic therapy was 5.5 months (95% CI, 4.0 to 8.0; n = 102), 4.4 months (2.7 to 7.1; n = 19), and 2.8 months (1.6 to 11.3; n = 16); the median PFS with prior second-line systemic therapy was 4.2 months (3.0 to 5.3; n = 39), 3.0 months (1.1 to 9.9; n = 8), and 5.9 months (2.4 to 12.5; n = 6). The median PFS was 7.0 months (4.9 to 11.1) for patients with <i>FGFR2</i> fusions/rearrangements (n = 65) with second-line pemigatinib received during the FIGHT-202 trial. In patients with CCA and <i>FGFR2</i> fusions or rearrangements, second-line treatment with pemigatinib may be associated with longer PFS compared with second-line treatment with systemic therapy received before study enrollment; however, a prospective controlled trial is required to confirm this. The results support the therapeutic potential of pemigatinib previously demonstrated in FIGHT-202.