Table 2

AEs related to the administration of tomuzotuximab with an incidence of ≥than 10% of the total population.

Dose (mg)Every weekEvery 2 weeksTotal population
12601202404807209901370Total990
No. of patients3343673635641
Any AE (total incidence≥10%)
No. (%) patients*
IRR at first infusion†2 (67)3 (100)4 (100)2 (67)5 (83)4 (57)2 (67)4 (67)26 (74)5 (83)31 (76)
 Grade 1001 (25)1 (33)2 (33)01 (33)1 (17)5 (14)1 (17)6 (15)
 Grade 22 (67)3 (100)3 (75)1 (33)2 (33)3 (43)1 (33)3 (50)19 (54)1 (17)20 (49)
 Grade 300001 (17)1 (14)002 (8)3 (50)5 (12)
Rash‡1 (33)02 (50)1 (33)3 (50)1 (14)3 (100)2 (33)13 (37)2 (66)15 (73)
Acne‡02 (66)1 (25)002 (29)02 (33)7 (20)3 (50)10 (24)
Dermatitis acneiform‡0001 (33)04 (57)2 (66)3 (50)10 (29)010 (24)
Dry skin‡001 (25)03 (50)1 (14)1 (33)06 (17)06 (15)
Pruritus‡001 (25)001 (14)1 (33)1 (17)4 (11)1 (17)5 (12)
Hypomagnesaemia§11 (14)2 (67)5 (83)8 (44)1 (17)9 (39)
Asthenia‡,§002 (50)1 (33)002 (67)1 (17)6 (17)06 (15)
Fatigue‡,§01 (33)01 (33)2 (33)001 (17)5 (14)05 (12)
  • *Percentage is calculated using the number of patients in the column heading as denominator. Patients are counted only once within a SOC category.

  • †Symptoms of IRR included chills (12 patients, 39%), tachycardia (eight patients, 26%), nausea (seven patients, 23%), vomiting (seven patients, 23%), dyspnoea (seven patients, 23%), fatigue (six patients, 15%), feeling hot (five patients, 16%), hypertension (four patients, 13%), fever (four patients, 13%) and asthenia (three patients, 7%).

  • ‡All grade 1 or 2.

  • §Magnesium was measured in 23 patients: in one patient in the 480 mg dose cohort and in all patients from dose 720 mg upwards. One patient had a grade 3, and another patient had three grade 3 and two grade 4 events, both patients received the highest dose. The median time to onset of hypomagnesaemia was 81.5 days, range 22–191 days.

  • ¶Not associated with an IRR.

  • AE, adverse events; IRR, infusion-related reaction; SOC, System Organ Class.