Observational studyCancer research communications2026
A Real-World Study of Patients with FGFR-Altered Advanced Solid Tumors after Exhaustion of Standard-of-Care Treatment.
Observational study in Cancer research communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04083976 (A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations), which is not on this map. Not yet cited in PubMed.
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A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
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8 authors.
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Abstract
Real-world outcome data for patients with FGFR gene alteration-positive (FGFRalt) advanced/metastatic solid tumors after standard-of-care (SOC) exhaustion are lacking. De-identified data from a custom-curated Flatiron Health Foundation Medicine Clinico-Genomic database were used in this retrospective, noninterventional, observational study. Eligible patients were ≥18 years of age with FGFRalt advanced/metastatic disease who had exhausted SOC treatment. Real-world overall survival (rwOS), progression-free survival (rwPFS), and treatment patterns were assessed. Primary analyses were weighted for tumor types in the RAGNAR clinical trial (NCT04083976) and accounted for delayed study entry. Data from 230 patients (FGFR fusions: 68.3%; FGFR mutations: 37%) across 18 tumor types were analyzed. In primary analyses, the median (95% confidence interval) rwOS was 183 (148-236) days, and the median rwPFS was 87 (63-196) days. The median rwOS ranged from 86 [41-not available (NA)] to 356 (299-NA) days across tumor types and was 161 (106-212) days for patients with FGFR fusions and 236 (82-538) days for patients with FGFR mutations. Most patients had received one (67.4%) or two (18.2%) lines of therapy/treatment blocks at SOC exhaustion. From first-line therapy to SOC exhaustion, most common treatments were chemotherapy (100%) and immunotherapy (17.4%), and from best supportive care after SOC exhaustion to death was chemotherapy (65.2%), immunotherapy (16.1%), and a clinical trial drug (15.5%). These real-world survival and treatment-pattern findings highlight the poor prognosis of and unmet medical needs for patients with FGFRalt advanced/metastatic solid tumors who have exhausted SOC treatment. SIGNIFICANCE: Findings from this real-world study-that patients with FGFRalt advanced/metastatic solid tumors have poor prognosis after SOC therapy exhaustion-contextualize results from the RAGNAR trial and suggest improved outcomes with erdafitinib. The rarity and poor prognosis of FGFR alterations highlight why randomized controlled trials in this population may be infeasible.
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