A real-world study of patients with FGFR-altered advanced solid tumors after exhaustion of standard-of-care treatment.

Real-world outcomes data for patients with fibroblast growth factor receptor (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, non-interventional, observational study. Eligible patients were ≥18 years old 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: 37.0%) across 18 tumor types were analyzed. In primary analyses, median (95% CI) rwOS was 183.0 (148.0, 236.0) days, and median rwPFS was 87 (63.0, 196.0) days. Median rwOS ranged from 86.0 (41, 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 (100.0%) and immunotherapy (17.4%), and from best supportive care after SOC exhaustion to death were 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 high unmet medical need for patients with FGFRalt advanced/metastatic solid tumors who have exhausted SOC treatment.