Table 2.

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 MBC2.4 mg/kg NSCLC0.2–2.4 mg/kg All patients
MedDRA term(n = 29)a(n = 25)(N = 68)
Patients with ≥1 AE29 (100)23 (92)63 (93)
 Alopecia20 (69)13 (52)36 (53)
 Fatigue15 (52)10 (40)31 (46)
 Nausea12 (41)8 (32)26 (38)
 Peripheral neuropathyb13 (45)6 (24)22 (32)
  Peripheral sensory neuropathy12 (48)3 (12)16 (24)
  Peripheral motor neuropathy8 (28)08 (12)
  Paresthesia1 (3)2 (8)4 (6)
 Chills8 (28)5 (20)19 (28)
 Decreased appetite8 (28)7 (28)19 (28)
 Diarrhea8 (28)4 (16)14 (21)
 Constipation9 (31)1 (4)12 (18)
 Aspartate aminotransferase increased6 (21)5 (20)11 (16)
 Back pain6 (21)2 (8)10 (15)
 Alanine aminotransferase increased6 (21)3 (12)9 (13)
 Anemia7 (24)1 (4)8 (12)
 Dry mouth4 (14)1 (4)8 (12)
 Mucosal inflammation6 (21)1 (4)9 (13)
 Myalgia5 (18)2 (8)9 (13)
 Neutropenia4 (14)5 (20)9 (13)
 Pruritus8 (28)1 (4)9 (13)
 Vomiting4 (14)3 (12)8 (12)
 Arthralgia5 (17)07 (10)
 Dry eye4 (14)3 (12)7 (10)
 Headache5 (17)07 (10)
 Pyrexia4 (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.