Real-world treatment patterns and clinical outcomes among cholangiocarcinoma patients treated with futibatinib or pemigatinib.

4109 Background: Pemigatinib and futibatinib are FGFR2 inhibitors approved by the US Food and Drug Administration in 2020 and 2022, respectively, for the treatment of advanced cholangiocarcinoma (CCA). This study describes demographic and clinical characteristics, and assesses clinical outcomes of real-world CCA patients treated with futibatinib or pemigatinib. Methods: This study used deidentified data from electronic medical records and claims from the ConcertAI RWD360 oncology dataset. Patients diagnosed with CCA and with evidence of initial treatment with futibatinib or pemigatinib in 2023 or later (index treatment) were included. Real-world outcomes (real-world overall survival [rwOS], time to discontinuation [rwTTD], and time to next treatment or death [rwTTNTD]) from the index date were described using Kaplan-Meier analysis. Cox regression models were used to adjust for patient characteristics. Adverse medical events of interest (MEI) were identified with ICD codes. Results: This study included 122 futibatinib (median age: 64 years; female: 58%; White: 66%) and 93 pemigatinib patients (median age: 66 years; female: 61%; White: 69%). The most common treatment regimen before index was cisplatin + durvalumab + gemcitabine (44% futibatinib and 35% pemigatinib patients). Futibatinib patients had numerically longer median rwOS (10.5 vs. 9.6 months) and median rwTTNTD (6.5 vs. 5.6 months) than pemigatinib patients, though the differences were not statistically significant; median rwTTD was similar in both futibatinib and pemigatinib patients (2.8 vs. 2.8 months); and adjusted hazard ratios were non-significant for all outcomes (Table 1). Futibatinib had numerically higher 6-month rwOS (63% vs. 55%) and 12-month rwOS (42% vs. 36%). Overall, 28% (n=60) of patients experienced MEI during index treatment: 29% (35/122 patients) in the futibatinib group and 27% (25/93) in the pemigatinib group. The most common MEI were (futibatinib vs. pemigatinib) fatigue (8% vs. 16%), diarrhea (10% vs. 5%), and dry eyes (6% vs. 1%). Conclusions: This study represents the largest real-world analysis to date of CCA patients treated with FGFR inhibitors. Overall, patient characteristics and MEI were similar in the two treatment groups. Clinical outcomes were also similar in both groups, suggesting that futibatinib is a promising alternative in this patient population. Outcome results. Futibatinib Patients (n=122) Pemigatinib Patients (n=93) P-Value Median rwOS, months (95% CI) 10.5 (7.3, 14.4) 9.6 (5.2, 10.8) 0.39 Adjusted HR 0.95 Ref. 0.65 Median rwTTD, months (95% CI) 2.8 (1.2, 3.7) 2.8 (1.7, 4.0) 0.51 Adjusted HR 1.10 Ref. 0.47 Median rwTTNTD, months (95% CI) 6.5 (4.8, 8.1) 5.6 (4.1, 7.4) 0.66 Adjusted HR 1.00 Ref. 0.99 HR: hazard ratio. Variables adjusted for in Cox model: age, sex, setting of care, ECOG performance status, and time from diagnosis to index date.