Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
Erdafitinib in Patients with FGFR-Altered Advanced or Metastatic Cholangiocarcinoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Targeting cancer-associated fibroblasts: therapeutic strategies, translational challenges, and future perspectives.Journal of hematology & oncology · 2026Review
- Incidence and outcomes of FGFR inhibitor-associated retinopathy of patients treated with oral erdafitinib across the clinical trial program.The oncologist · 2026Article
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Authors and funding
20 authors.
Funding
Abstract
purposeUp to 20% of patients with cholangiocarcinoma (CCA) harbor FGFR gene aberrations. Erdafitinib is approved for pretreated, locally advanced/metastatic urothelial carcinoma with susceptible FGFR3 alterations. The present study evaluated the efficacy and safety of erdafitinib using a pooled analysis of patients with CCA from the RAGNAR and LUC2001 studies. EXPERIMENTAL
designIn RAGNAR (phase II, global, tumor-agnostic study) and LUC2001 (an open-label, multicenter, phase IIa study in Asian patients), patients with advanced solid tumors after ≥1 prior lines of therapy received once daily oral erdafitinib (8 mg/day with an option for pharmacodynamically guided up-titration to 9 mg). Patients were pooled for efficacy [objective response rate (ORR) per blinded independent review committee, duration of response (DOR), progression-free survival (PFS), and overall survival (OS)] and safety analyses.
resultsAt a median efficacy follow-up of 14.7 months in 78 erdafitinib-treated patients (RAGNAR: n = 66; LUC2001: n = 12), ORR was 55% [95% confidence interval (CI), 43.4-66.4]. The median time to response was 1.7 months; the median DOR, PFS, and OS were 6.9 (95% CI, 4.37-8.61), 8.5 (95% CI, 6.83-9.72), and 18.1 (95% CI, 13.40-24.28) months, respectively. The most common treatment-emergent adverse events (TEAE) were hyperphosphatemia (83%), stomatitis (72%), diarrhea (68%), dry mouth (51%), and palmar-plantar erythrodysesthesia (51%); 42% had serious TEAEs, and 12% had TEAEs leading to treatment discontinuation.
conclusionsPooled analyses confirm the robust efficacy of erdafitinib in a diverse population of pretreated patients with advanced/metastatic CCA harboring prespecified FGFR alterations. These findings are consistent with previously observed efficacy of FGFR-targeted agents in patients with CCA.
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