Table 1.
Baseline characteristics and prior therapy in patients receiving futibatinib 20 mg once daily
| Characteristic | 20-mg cohort (N = 170) |
|---|---|
| Age, years | |
| Mean (SD) | 56.0 (13.1) |
| Sex, n (%) | |
| Female | 95 (55.9) |
| Male | 75 (44.1) |
| Race, n (%) | |
| White | 100 (58.8) |
| Asian | 21 (12.4) |
| Black or African American | 4 (2.4) |
| Native Hawaiian or other Pacific Islander | 1 (0.6) |
| Unknown | 44 (25.9) |
| ECOG PS, n (%) | |
| 0 | 51 (30.0) |
| 1 | 119 (70.0) |
| FGF/FGFR alteration,an (%) | |
| FGFR1 | |
| Fusions/rearrangement | 5 (2.9) |
| Mutation | 10 (5.9) |
| Amplification | 2 (1.2) |
| FGFR2 | |
| Fusions/rearrangement | 48 (28.2) |
| Mutation | 23 (13.5) |
| Amplification | 21 (12.4) |
| FGFR3 | |
| Fusions/rearrangement | 32 (18.8) |
| Mutation | 15 (8.8) |
| Amplification | 3 (1.8) |
| FGFR4 mutation | 3 (1.8) |
| FGF1/3/4/19 amplification | 23 (13.5) |
| Cancer type, n (%) | |
| Cholangiocarcinoma | 64 (37.6) |
| Intrahepatic | 61 (35.9) |
| Extrahepatic | 3 (1.8) |
| Primary CNS | 36 (21.2) |
| Urothelial | 19 (11.2) |
| Breast | 11 (6.5) |
| Gastric | 9 (5.3) |
| Other solid tumorsb | 31 (18.2) |
| Type of prior therapy, n (%) | |
| Chemotherapy | 161 (94.7) |
| Targeted therapy | 58 (34.1) |
| FGFR inhibitor | 33 (19.4) |
| Immunotherapy | 31 (18.2) |
| Hormonal therapy | 7 (4.1) |
| Other | 16 (9.4) |
| Number of prior regimens, n (%) | |
| 1 | 35 (20.6) |
| 2 | 43 (25.3) |
| 3 | 39 (22.9) |
| 4 | 18 (10.6) |
| ≥5 | 28 (16.5) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; FGF, fibroblast growth factor.
aFourteen patients had more than one type of FGF/FGFR aberration.
bSarcoma (n = 6); colorectal cancer (n = 5); endometrial, esophageal, and gallbladder cancer (n = 3 each); head and neck cancer (n = 2); adrenal cortical cancer, lung cancer, mesothelioma, ovarian cancer, pancreatic cancer, and thyroid cancer (n = 1 each); and primary unknown (n = 3).