Real-world patient characteristics and treatment patterns among cholangiocarcinoma patients treated with FGFR inhibitors.

e16262 Background: Pemigatinib and futibatinib are targeted therapies approved by the US Food and Drug Administration in 2020 and 2022, respectively, for the treatment of advanced cholangiocarcinoma (CCA) harboring FGFR2 gene fusions or rearrangements. Limited data are available to describe the usage of these drugs in clinical trials and in the real world. This is the first real-world study to examine the patient characteristics and treatment patterns of patients with CCA treated with pemigatinib or futibatinib. 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 pemigatinib or futibatinib in 2023 or later were included, with the first FGFR inhibitor as the index treatment. Patient characteristics and treatment patterns pre- and post-index were examined. Adverse medical events of interest (MEI) were identified with ICD codes. Kaplan-Meier analyses were used to describe the real-world time to discontinuation (rwTTD) and time to next treatment or death (rwTTNTD) from the index date. Results: This study included 50 futibatinib and 55 pemigatinib patients. Overall, patient characteristics were similar across the two treatment groups (Table 1). The most common treatment regimen before index was cisplatin + gemcitabine + durvalumab (pemigatinib patients 38%, futibatinib patients 28%). Approximately 15% of patients in both groups received a subsequent line of therapy after the index treatment. Occurrence of any adverse MEI during the index treatment was similar in pemigatinib (33%) and futibatinib (28%) patients (p = 0.60); the most common MEI for pemigatinib and futibatinib patients were fatigue (18% and 12%, respectively) and diarrhea (5% and 12%, respectively). Other MEIs, including retinal pigment epithelial detachment, nail disorders, Palmar-Plantar erythrodysesthesia, dry eye, etc., were less common. Patients treated with futibatinib and pemigatinib had similar median rwTTD (2.9 vs 3.1 months, respectively) and rwTTNTD (5.7 vs 5.4 months, respectively). Conclusions: Overall, patient demographics, prior treatment regimens, and adverse MEI were similar across the two treatment groups. Patients treated with futibatinib and pemigatinib demonstrated comparable real-world treatment pattern characteristics. Additional comprehensive analysis on survival outcomes and safety profile will be performed when a larger sample size is available. Patient characteristics. Futibatinib Patients (n=50) Pemigatinib Patients (n=55) P-Value Age at index, yrs (median) 67.5 66 0.27 White (%) 68.0% 67.3% 0.94 Female (%) 52.0% 61.8% 0.31 Weighted Charlson comorbidity index score (%) 0.24 0 40.0% 30.9% 1 22.0% 23.6% 2+ 38.0% 45.5% CCA diagnosis to index, days (median) 251 219 0.82 Index date to end of record, days (median) 148 91 0.20