Table 1.
Summary of TEAEs: Approved FGFR inhibitors
| Erdafitinib BLC2001 (N = 99)a,14 |
Pemigatinib FIGHT-202 (N = 146)b,24 |
Futibatinib TPU-TAS-120-101 (N = 170)c,17 |
||||||
|---|---|---|---|---|---|---|---|---|
| AE, n (%) | Any grade | Grade ≥ 3 | AE, n (%) | Any grade | Grade ≥ 3 | AE, n (%) | Any grade | Grade ≥ 3 |
| Hyperphosphatemia | 76 (77) | 2 (2) | hyperphosphatemia | 88 (60) | 0 | hyperphosphatemia | 138 (81) | 38 (22) |
| Stomatitis | 57 (58) | 10 (10) | alopecia | 72 (49) | 0 | diarrhea | 56 (33) | 1 (1) |
| Diarrhea | 50 (51) | 4 (4) | diarrhea | 68 (47) | 4 (3) | constipation | 54 (32) | 2 (1) |
| Dry mouth | 45 (46) | 0 | fatigue | 62 (42) | 7 (5) | nausea | 48 (28) | 0 |
| Decreased appetite | 38 (38) | 0 | dysgeusia | 59 (40) | 0 | fatigue | 43 (25) | 9 (5) |
| Dysgeusia | 37 (37) | 1 (1) | nausea | 58 (40) | 3 (2) | vomiting | 43 (25) | 2 (1) |
| Fatigue | 32 (32) | 2 (2) | constipation | 51 (35) | 1 (1) | AST increased | 41 (24) | 9 (5) |
| Dry skin | 32 (32) | 0 | stomatitis | 51 (35) | 8 (5) | ALT increased | 40 (24) | 17 (10) |
| Alopecia | 29 (29) | 0 | dry mouth | 49 (34) | 0 | abdominal pain | 33 (19) | 5 (3) |
| Constipation | 28 (28) | 1 (1) | decreased appetite | 48 (33) | 2 (1) | alopecia | 33 (19) | 0 |
| Hand-foot syndrome | 23 (23) | 5 (5) | vomiting | 40 (27) | 2 (1) | decreased appetite | 32 (19) | 3 (2) |
| Anemia | 20 (20) | 4 (4) | dry eye | 37 (25) | 1 (1) | dry mouth | 30 (18) | 0 |
| Asthenia | 20 (20) | 7 (7) | arthralgia | 36 (25) | 9 (6) | asthenia | 27 (16) | 7 (4) |
| Nausea | 20 (20) | 1 (1) | abdominal pain | 33 (23) | 7 (5) | stomatitis | 26 (15) | 5 (3) |
| Dry eye | 19 (19) | 1 (1) | hypophosphatemia | 33 (23) | 18 (12) | anemia | 23 (14) | 9 (5) |
| Onycholysis | 18 (18) | 2 (2) | back pain | 29 (20) | 4 (3) | dry skin | 22 (13) | 0 |
| ALT increased | 17 (17) | 2 (2) | dry skin | 29 (20) | 1 (1) | PPES | 22 (13) | 6 (4) |
| Paronychia | 17 (17) | 3 (3) | pain in extremity | 28 (19) | 3 (2) | increased blood creatinine | 20 (12) | 0 |
| Blurred vision | 17 (17) | 0 | edema, peripheral | 26 (18) | 1 (1) | arthralgia | 19 (11) | 0 |
| Nail dystrophy | 16 (16) | 6 (6) | weight decreased | 24 (16) | 3 (2) | hypercalcemia | 19 (11) | 2 (1) |
| Urinary tract infection | 16 (16) | 5 (5) | headache | 23 (16) | 0 | dysgeusia | 18 (11) | 0 |
| Vomiting | 13 (13) | 2 (2) | urinary tract infection | 23 (16) | 4 (3) | decreased weight | 17 (10) | 1 (1) |
| Hyponatremia | 12 (12) | 11 (11) | dehydration | 22 (15) | 5 (3) | |||
| Hematuria | 10 (10) | 2 (2) | hypercalcemia | 22 (15) | 3 (2) | |||
| Dyspnea | 8 (8) | 2 (2) | PPES | 22 (15) | 6 (4) | |||
| Nail disorder | 8 (8) | 3 (3) | anemia | 21 (14) | 5 (3) | |||
| Acute kidney injury | 6 (6) | 2 (2) | epistaxis | 20 (14) | 0 | |||
| Cataract | 6 (6) | 2 (2) | pyrexia | 20 (14) | 1 (1) | |||
| Colitis | 5 (5) | 2 (2) | asthenia | 19 (13) | 2 (1) | |||
| General deterioration in physical health | 5 (5) | 4 (4) | dizziness | 19 (13) | 1 (1) | |||
| Keratitis | 5 (5) | 3 (3) | myalgia | 18 (12) | 2 (1) | |||
| Aphthous ulcer | 4 (4) | 2 (2) | hyponatremia | 16 (11) | 8 (5) | |||
| GGT increased | 3 (3) | 2 (2) | blood creatinine increased | 16 (11) | 2 (1) | |||
| Urosepsis | 3 (3) | 3 (3) | gastroesophageal reflux disease | 16 (11) | 1 (1) | |||
| musculoskeletal pain | 15 (10) | 0 | ||||||
| blood alkaline phosphatase increased | 14 (10) | 5 (3) | ||||||
| onychomadesis | 14 (10) | 0 | ||||||
| dyspnea | 14 (10) | 1 (1) | ||||||
| nail discoloration | 14 (10) | 1 (1) | ||||||
ALT, alanine aminotransferase; AST, aspartate aminotransferase; FGFR, fibroblast growth factor receptor; GGT, γ-glutamyltransferase; PPES, palmar-plantar erythrodysesthesia syndrome; TEAE, treatment-emergent adverse event.
TEAEs occurring in 15% or more of patients (N = 99) with locally advanced or metastatic UC with susceptible FGFR3 or FGFR2 genetic alterations receiving erdafitinib (8 mg or 9 mg) on a continuous dosing regimen.14
TEAEs occurring in 10% or more of patients (N = 146) with locally advanced or metastatic CCA and FGF/FGFR alterations receiving pemigatinib (13.5 mg once daily). MedDRA preferred terms related to hyperphosphatemia were combined: blood phosphorus increased, hyperphosphatemia. MedDRA preferred terms related to hypophosphatemia were combined: blood phosphorus decreased, hypophosphatemia.24
TEAEs occurring in 10% or more of patients (N = 170) receiving futibatinib (20 mg) for advanced solid tumors and FGF/FGFR aberrations.17