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Association details:
| Biomarker: | FGFR mutation |
|---|---|
| Cancer: | Cholangiocarcinoma |
| Drug: | Balversa (erdafitinib) (FGFR inhibitor, FGFR1 inhibitor, FGFR4 inhibitor, FGFR2 inhibitor, FGFR3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Efficacy and safety of erdafitinib in adults with cholangiocarcinoma (CCA) with prespecified fibroblast growth factor receptor alterations (FGFRalt) in the phase 2 open-label, single-arm RAGNAR trial: Expansion cohort results.
Published date:
01/17/2023
Excerpt:
ORR by IRC was 60.0% (95% CI 42.1-76.1). Median time to onset of response was 1.5 mo (range 1.1-8.2). Responses were observed in pts harboring FGFR mutations and fusions and in pts with co-occurring genomic alterations. Median DCR and CBR were 100.0% (95% CI 90.0-100.0) and 71.4% (95% CI 53.7-85.4), respectively. Median DOR, PFS, and OS were 5.6 mo (95% CI 2.8-8.3), 8.4 mo (95% CI 5.5-9.7), and 18.7 mo (95% CI 8.9-not evaluable), respectively...Data from the CCA expansion cohort of the phase 2 RAGNAR study demonstrate robust efficacy of erda in heavily pretreated adults with CCA harboring prespecified FGFR fusions or mutations, irrespective of co-occurring genomic alterations.
DOI:
10.1200/JCO.2023.41.3_suppl.610
Trial ID:
