Background: Pemi received accelerated approval by the FDA in 2020 for treatment of patients (pts) with unresectable locally advanced or metastatic CCA with a fibroblast growth factor receptor 2 (FGFR2) fusion or other FGFR2 rearrangement. A recent real-world study (RWS; submitted to ASCO-GI 2024) assessing characteristics, FGFR2 testing patterns, treatment patterns, and outcomes of pts treated with pemi for locally advanced or metastatic CCA in the US as part of routine clinical care found substantial racial and ethnic diversity in pts treated with pemi. The purpose of this analysis is to describe the findings of the pemi RWS for CCA by race and ethnicity. Methods: This was a retrospective cohort study in which US-based participating physicians from Cardinal Health’s Oncology Provider Extended Network abstracted data from eligible pts’ medical records into electronic case report forms. Eligible pts were ≥18 years of age, initially prescribed pemi for unresectable locally advanced or metastatic CCA on or after 4/17/2020, and had ≥4 mo of follow-up (unless <4 mo due to death). Pts who did not receive pemi or had received pemi in a clinical trial or systemic therapy for another primary malignancy (except for cancer of unknown primary or hepatic cancer) were excluded. Results were summarized by race (White, Black/African American, “Other” [pts with mixed race or a race other than White, Black/African American, or Unknown]) and ethnicity (Non-Hispanic, Hispanic) using descriptive statistics. Results: 18 physicians abstracted data for 120 eligible pts. Median follow-up from initial pemi prescription was 6.5 mo, at which time 71 pts (59%) were alive and 60 (50%) were still receiving pemi. The racial makeup of the study population was 55% White, 21% Black, 18% Other, and 7% Unknown. Ethnic composition was 78% Non-Hispanic, 19% Hispanic, and 3% Unknown. Key results are presented in the Table. Conclusions: The diverse population in this RWS is reflective of the heterogeneous CCA pt population in the US. These real-world overall response rates support the clinical benefit of pemi across racial and ethnic groups and complement the results of the clinical trial.

BL, baseline (date of 1st pemi prescription); CI, confidence interval; FGFR2, fibroblast growth factor receptor 2; P25-P75, 25-75th percentile; rwORR, real-world overall response rate; y, years.