TABLE 3.
Treatment-Related, Treatment-Emergent Adverse Events Reported in ≥10% of Patients
| IMGN853 Dose, mg/kg: No. of Patients (%) | ||||||
|---|---|---|---|---|---|---|
| Adverse Event | Total, n = 44 | 0.15–2.0, n = 5a | 3.3, n = 9 | 5.0, n = 18b | 6.0, n = 7 | 7.0, n = 5 |
| Fatigue | 11 (25) | 0 (0) | 2 (22.2) | 3 (16.7) | 3 (42.9) | 3 (60) |
| Vision blurred | 10 (22.7) | 0 (0) | 0 (0) | 3 (16.7) | 2 (28.6) | 5 (100) |
| Diarrhea | 9 (20.5) | 0 (0) | 1 (11.1) | 6 (33.3) | 1 (14.3) | 1 (20) |
| Peripheral neuropathyc | 9 (20.5) | 0 (0) | 2 (22.2) | 4 (22.2) | 1 (14.3) | 2 (40) |
| ALT increased | 7 (15.9) | 0 (0) | 0 (0) | 4 (22.2) | 1 (14.3) | 2 (40) |
| Keratopathyd | 7 (15.9) | 0 (0) | 0 (0) | 3 (16.7) | 2 (28.6) | 2 (40) |
| AST increased | 6 (13.6) | 0 (0) | 1 (11.1) | 3 (16.7) | 0 (0) | 2 (40) |
| Headache | 5 (11.4) | 0 (0) | 1 (11.1) | 3 (16.7) | 0 (0) | 1 (20) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; IMGN853, mirvetuximab soravtansine.
a
The include patients who received IMGN853 at doses of 0.15, 0.5, 1.0, and 2.0 mg/kg.
b
These include the initial 11 patients who were dosed based on total body weight and the additional 7 who were dosed according to adjusted ideal body weight.
c
These events include neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, and hypoesthesia.
d
These events include corneal epithelial microcysts, corneal opacity, corneal erosion, corneal pigmentation, and punctate keratitis.