Table 1.
Treatment-Related Adverse Events of Enfortumab Vedotin Monotherapy When Administered at a Dose of 1.25 mg/kg*
| Adverse Event (AE) | EV-101, % (n = 112) | EV-201, % (n = 125) | FDA Management Recommendations | ||
|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | ||
| Fatigue | 53 | 2 | 50 | 6 | Grade 3: B Grade 4: D |
| Alopecia | 46 | 0 | 49 | 0 | Grade 3: B Grade 4: D |
| Decreased appetite | 47 | 1 | 44 | 1 | Grade 3: B Grade 4: D |
| Dysgeusia | 38 | 0 | 40 | 0 | Grade 3: B Grade 4: D |
| Peripheral sensory neuropathy | 38 | 1 | 40 | 2 | Grade 2: A Recurrent Grade 2: C Grade ≥ 3: D |
| Diarrhea | 33 | 1 | 40 | 2 | Grade 3: B Grade 4: D |
| Rash | 27 | 3 | 22 | 4 | Grade 3: B Grade 4 or recurrent Grade 3: D |
| Dry skin | 21 | 0 | 22 | 0 | Grade 3: B Grade 4 or recurrent Grade 3: D |
| Nausea | 38 | 1 | NR | NR | Grade 3: B Grade 4: D |
| Pruritis | 35 | 1 | NR | NR | Grade 3: B Grade 4 or recurrent Grade 3: D |
| Weight loss | NR | NR | 22 | 1 | Grade 3: B Grade 4: D |
| Increased AST | 22 | 1 | NR | NR | Grade 3: B Grade 4: D |
Notes: A, withhold until grade ≤1 and resume at same dose level; B, withhold until grade ≤1 and resume at same dose level or consider reduction by 1 dose level; C, withhold until grade ≤1 and resume at reduction by 1 dose level; D, permanently discontinue. *Starting dose of 1.25 mg/kg (up to 125 mg). First dose reduction of 1.0 mg/kg (up to 100 mg). Second dose reduction of 0.75 mg/kg (up to 75 mg). Third dose reduction of 0.5 mg/kg (up to 50 mg).
Abbreviations: AST, aspartate aminotransferase; EV, enfortumab vedotin; NR, not reported.