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    Association details:
    Biomarker:FGFR2 fusion
    Cancer:Urothelial Cancer
    Drug:Balversa (erdafitinib) (FGFR inhibitor, FGFR1 inhibitor, FGFR4 inhibitor, FGFR2 inhibitor, FGFR3 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2023
    Title:

    2362MO - Erdafitinib (erda) vs chemotherapy (chemo) in patients (pts) with advanced or metastatic urothelial cancer (mUC) with select FGFR alterations (FGFRalt): Subgroups from the phase III THOR study

    Published date:
    10/16/2023
    Excerpt:
    Pts (≥18 y) with unresectable advanced/mUC and select FGFR3/2alt (mutations/fusions)...Primary end point was met: mOS 12.1 vs 7.8 mo in erda vs chemo (HR=0.64; 95% CI, 0.47-0.88). OS benefit was seen across subgroups (Table). Erda improved mPFS (6 vs 3 mo) and ORR (46% vs 12%) vs chemo...In pts with FGFRalt advanced/mUC after prior anti-PD-(L)1 tx, erda significantly improved OS vs chemo. Clinically relevant subgroups showed a consistent OS benefit for erda. No new safety signals were observed.
    Trial ID:
    THOR
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    N Engl J Med
    Title:

    Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma

    Excerpt:
    The patients were required to have at least one FGFR3 mutation or FGFR2/3 fusion...Among the 25 patients with FGFR fusions, the response rate was 16%.
    DOI:
    10.1056/NEJMoa1817323