Table 2.
Summary of TEAEs: FGFR inhibitors not yet approved
| Derazantinib ARQ 087–101 (N = 29)a,25 |
Rogaratinib 16443 (N = 126)b,18 |
||||
|---|---|---|---|---|---|
| AE, n (%) | Any grade | Grade ≥ 3 | AE, n (%) | Any grade | Grade ≥ 3 |
| Dry mouth | 13 (44.8) | 0 | hyperphosphatemia | 77 (61) | 1 (1) |
| Nausea | 13 (44.8) | 0 | diarrhea | 65 (52) | 3 (2) |
| Fatigue | 10 (34.5) | 1 (3.4) | decreased appetite | 48 (38) | 3 (2) |
| Asthenia | 10 (34.5) | 2 (6.9) | fatigue | 42 (33) | 12 (10) |
| Dysgeusia | 9 (31.0) | 0 | nausea | 37 (29) | 2 (2) |
| Vomiting | 9 (31.0) | 1 (3.4) | constipation | 33 (26) | 1 (1) |
| Alopecia | 7 (24.1) | 0 | anemia | 26 (21) | 9 (7) |
| Vision blurred | 7 (24.1) | 1 (3.4) | dry mouth | 26 (21) | 0 |
| Diarrhea | 6 (20.7) | 0 | alopecia | 25 (20) | 0 |
| ALT increased | 6 (20.7) | 1 (3.4) | arthralgia | 25 (20) | 0 |
| Dry eye | 5 (17.2) | 1 (3.4) | dysgeusia | 25 (20) | 0 |
| Decreased appetite | 5 (17.2) | 0 | urinary tract infection | 22 (17) | 8 (6) |
| AST increased | 5 (17.2) | 1 (3.4) | increased AST | 21 (17) | 1 (1) |
| Conjunctivitis | 4 (13.8) | 0 | back pain | 21 (17) | 2 (2) |
| Anemia | 3 (10.3) | 0 | dyspnea | 20 (16) | 8 (6) |
| Dry skin | 3 (10.3) | 0 | stomatitis | 19 (15) | 0 |
| Pruritus | 3 (10.3) | 0 | increased ALT | 18 (14) | 2 (2) |
| Visual acuity reduced | 3 (10.3) | 0 | increased blood creatinine | 18 (14) | 2 (2) |
| Dizziness | 2 (6.9) | 0 | dry skin | 18 (14) | 0 |
| Dermatitis | 2 (6.9) | 0 | increased lipase | 18 (14) | 10 (8) |
| Flatulence | 2 (6.9) | 0 | cough | 17 (13) | 1 (1) |
| Headache | 2 (6.9) | 0 | hypercalcemia | 17 (13) | 3 (2) |
| Neuropathy peripheral | 2 (6.9) | 0 | pyrexia | 17 (13) | 0 |
| Photophobia | 2 (6.9) | 0 | vomiting | 16 (13) | 2 (2) |
| Somnolence | 2 (6.9) | 0 | dry eye | 14 (11) | 0 |
| Thrombocytopenia | 2 (6.9) | 0 | insomnia | 14 (11) | 0 |
| Stomatitis | 2 (6.9) | 1 (3.4) | abdominal pain | 13 (10) | 1 (1) |
| Leukopenia | 1 (3.4) | 1 (3.4) | increased amylase | 13 (10) | 3 (2) |
| Upper gastrointestinal hemorrhage | 1 (3.4) | 1 (3.4) | asthenia | 13 (10) | 1 (1) |
| hemoptysis | 13 (10) | 3 (2) | |||
ALT, alanine aminotransferase; AST, aspartate aminotransferase; FGFR, fibroblast growth factor receptor; TEAE, treatment-emergent adverse event.
a
TEAEs related to treatment occurring in patients (N = 29) receiving derazantinib for unresectable iCCA with FGFR2 fusion.25
b
TEAEs occurring in patients (N = 126) receiving rogaratinib for advanced cancers.18