TABLE 3.
TEAEs in patients in the dose escalation (part 1) and dose expansion (part 2) cohorts
| Patient with any grade TEAE, n (%) | Part 1 | Part 2 | |
|---|---|---|---|
| TV 1.5 mg/kg | TV 2.0 mg/kg | TV 2.0 mg/kg | |
| (N = 3) | (N = 3) | (N = 17) | |
| TEAE | 3 (100) | 3 (100) | 17 (100.0) |
| Related to TV | 3 (100) | 3 (100) | 17 (100.0) |
| Grade ≥3 TEAE | 1 (33.3) | 1 (33.3) | 14 (82.4) |
| Related to TV | 0 | 1 (33.3) | 9 (52.9) |
| TESAE | 0 | 1 (33.3) | 8 (47.1) |
| Related to TV | 0 | 0 | 4 (23.5) |
| Fatal TEAE | 0 | 0 | 0 |
| Related to TV | 0 | 0 | 0 |
| Dose‐limiting toxicities | 0 | 0 | NA |
| TEAE leading to treatment interruption | 1 (33.3) | 1 (33.3) | 2 (11.8) |
| TEAE leading to dose reduction | 0 | 1 (33.3) | 3 (17.6) |
| TEAE leading to drug withdrawal | 0 | 0 | 1 (5.9) |
| Preferred term, TEAEs in ≥2 patients in any arm a | |||
| Abdominal pain, upper | 0 | 0 | 4 (23.5) |
| Alanine aminotransferase increased | 0 | 1 (33.3) | 3 (17.6) |
| Alopecia | 0 | 2 (66.7) | 8 (47.1) |
| Anemia | 0 | 2 (66.7) | 10 (58.8) |
| Anxiety | 0 | 0 | 2 (11.8) |
| Aspartate aminotransferase increased | 1 (33.3) | 1 (33.3) | 3 (17.6) |
| Back pain | 0 | 0 | 2 (11.8) |
| Blood alkaline phosphatase increased | 0 | 0 | 2 (11.8) |
| Conjunctivitis | 0 | 1 (33.3) | 3 (17.6) |
| Constipation | 2 (66.7) | 0 | 0 |
| Decreased appetite | 1 (33.3) | 1 (33.3) | 2 (11.8) |
| Diarrhea | 1 (33.3) | 0 | 6 (35.3) |
| Epistaxis | 2 (66.7) | 1 (33.3) | 8 (47.1) |
| γ‐Glutamyltransferase increased | 0 | 1 (33.3) | 2 (11.8) |
| Genital hemorrhage | 0 | 0 | 2 (11.8) |
| Insomnia | 1 (33.3) | 0 | 2 (11.8) |
| Lower gastrointestinal hemorrhage | 0 | 0 | 3 (17.6) |
| Malaise | 0 | 0 | 2 (11.8) |
| Myalgia | 0 | 0 | 2 (11.8) |
| Nausea | 3 (100.0) | 2 (66.7) | 10 (58.8) |
| Neutrophil count decreased | 0 | 2 (66.7) | 3 (17.6) |
| Peripheral edema | 0 | 0 | 2 (11.8) |
| Peripheral sensory neuropathy | 0 | 1 (33.3) | 3 (17.6) |
| Pyrexia | 1 (33.3) | 1 (33.3) | 3 (17.6) |
| Rash | 0 | 1 (33.3) | 2 (11.8) |
| Stomatitis | 0 | 0 | 2 (11.8) |
| Tumor hemorrhage | 0 | 0 | 2 (11.8) |
| Vomiting | 1 (33.3) | 0 | 3 (17.6) |
| White blood cell count decreased | 0 | 2 (66.7) | 4 (23.5) |
Abbreviations: NA, not applicable; TEAE, treatment‐emergent adverse event; TESAE, treatment‐emergent serious adverse event; TV, tisotumab vedotin.
a
TEAEs experienced by ≥2 patients in either part 1 (ie, both dose levels [N = 6]) or part 2.