AEs related to DLYE5953A in patients with MBC (2.4 mg/kg), NSCLC (2.4 mg/kg), and all patients (0.2–2.4 mg/kg), and with an occurrence of ≥10% in patients overall.
| 2.4 mg/kg MBC | 2.4 mg/kg NSCLC | 0.2–2.4 mg/kg All patients | |
|---|---|---|---|
| MedDRA term | (n = 29)a | (n = 25) | (N = 68) |
| Patients with ≥1 AE | 29 (100) | 23 (92) | 63 (93) |
| Alopecia | 20 (69) | 13 (52) | 36 (53) |
| Fatigue | 15 (52) | 10 (40) | 31 (46) |
| Nausea | 12 (41) | 8 (32) | 26 (38) |
| Peripheral neuropathyb | 13 (45) | 6 (24) | 22 (32) |
| Peripheral sensory neuropathy | 12 (48) | 3 (12) | 16 (24) |
| Peripheral motor neuropathy | 8 (28) | 0 | 8 (12) |
| Paresthesia | 1 (3) | 2 (8) | 4 (6) |
| Chills | 8 (28) | 5 (20) | 19 (28) |
| Decreased appetite | 8 (28) | 7 (28) | 19 (28) |
| Diarrhea | 8 (28) | 4 (16) | 14 (21) |
| Constipation | 9 (31) | 1 (4) | 12 (18) |
| Aspartate aminotransferase increased | 6 (21) | 5 (20) | 11 (16) |
| Back pain | 6 (21) | 2 (8) | 10 (15) |
| Alanine aminotransferase increased | 6 (21) | 3 (12) | 9 (13) |
| Anemia | 7 (24) | 1 (4) | 8 (12) |
| Dry mouth | 4 (14) | 1 (4) | 8 (12) |
| Mucosal inflammation | 6 (21) | 1 (4) | 9 (13) |
| Myalgia | 5 (18) | 2 (8) | 9 (13) |
| Neutropenia | 4 (14) | 5 (20) | 9 (13) |
| Pruritus | 8 (28) | 1 (4) | 9 (13) |
| Vomiting | 4 (14) | 3 (12) | 8 (12) |
| Arthralgia | 5 (17) | 0 | 7 (10) |
| Dry eye | 4 (14) | 3 (12) | 7 (10) |
| Headache | 5 (17) | 0 | 7 (10) |
| Pyrexia | 4 (14) | 2 (8) | 7 (10) |
↵aSix of the patients with MBC were studied in the 2.4 mg/kg dose-escalation cohort, and 23 were studied in the dose-expansion cohort at the RP2D of 2.4 mg/kg. See Supplementary Table S3 for all common AEs occurring in patients with MBC and NSCLC treated at the RP2D of 2.4 mg/kg. Supplementary Table S4 provides a summary of AEs in patients who participated in the dose-escalation cohort, including one patient with ovarian cancer treated at 2.4 mg/kg.
↵bPeripheral neuropathy includes the following terms: peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, neuralgia, hypoesthesia, paresthesia, and muscular weakness. Terms with incidence n = 1 in the total patient population are not included in Table 2. Some patients experienced more than one peripheral neuropathy event.