TABLE 1.
Summary of TEAEs and DLTs in i.v. and s.c. dosing cohorts
| IV cohorts 1–5 (Q2W) | IV cohorts 6–11 (twice weekly) | SC cohorts 1–2 (twice weekly) | Overall | |
|---|---|---|---|---|
| Analysis set: all treated | 17 | 36 | 9 | 62 |
| Any TEAE (%) | 15 (88.2) | 35 (97.2) | 9 (100) | 59 (95.2) |
| Drug‐related a | 9 (52.9) | 21 (58.3) | 9 (100) | 39 (62.9) |
| Any serious TEAE (%) | 10 (58.8) | 23 (63.9) | 7 (77.8) | 40 (64.5) |
| Drug‐related a | 4 (23.5) | 8 (22.2) | 1 (11.1) | 13 (21) |
| Infection | 6 (35.3) | 13 (36.1) | 4 (44.4) | 23 (37.1) |
| Maximum severity of a TEAE (%) | ||||
| Grade 1 | 0 | 1 (2.8) | 0 | 1 (1.6) |
| Grade 2 | 4 (23.5) | 1 (2.8) | 1 (11.1) | 6 (9.7) |
| Grade 3 | 6 (35.3) | 7 (19.4) | 1 (11.1) | 14 (22.6) |
| Grade 4 | 2 (11.8) | 22 (61.1) | 6 (66.7) | 30 (48.4) |
| Grade 5 | 3 (17.6) | 4 (11.1) | 1 (11.1) | 8 (12.9) |
| Treatment discontinuations due to TEAE b (%) | 2 (11.8) | 6 (16.7) | 2 (22.2) | 10 (16.1) |
| Drug related a | 1 (5.9) | 3 (8.3) | 0 | 4 (6.5) |
| Any DLT TEAE (%) | 1 (5.9) | 1 (2.8) | 0 | 2 (3.2) |
| Drug related a | 1 (5.9) | 1 (2.8) | 0 | 2 (3.2) |
| Any CRS (%) | 5 (29.4) | 16 (44.4) | 6 (66.7) | 27 (43.5) |
| Drug related a | 5 (29.4) | 16 (44.4) | 6 (66.7) | 27 (43.5) |
| Serious | 3 (17.6) | 6 (16.7) | 0 | 9 (14.5) |
| Time to CRS onset (days) c , n d | 5 | 16 | 6 | 27 |
| Mean (SD) | 3.8 (6.3) | 23.0 (17.6) | 2.3 (1.4) | 14.9 (16.9) |
| Median | 1.0 | 23.0 | 2.0 | 6.0 |
| Range | (1; 15) | (1; 51) | (1; 5) | (1; 51) |
| Death due to TEAE (%) | 3 (17.6) | 4 (11.1) | 1 (11.1) | 8 (12.9) |
| Drug related a (%) | 2 (11.8) | 0 | 0 | 2 (3.2) |
| Infusion reaction TEAE (%) | 0 | 7 (19.4) | NA | 7 (11.3) |
| Drug related a (%) | 0 | 7 (19.4) | NA | 7 (11.3) |
| Serious (%) | 0 | 2 (5.6) | NA | 2 (3.2) |
| Injection site reaction TEAE (%) | NA | NA | 9 (100.0) | 9 (14.5) |
| Drug related a (%) | NA | NA | 9 (100.0) | 9 (14.5) |
| Serious | NA | NA | 0 | 0 |
Abbreviations: CRS, cytokine release syndrome; DLT, dose limiting toxicity; Q2W, once every 2 weeks; TEAE, treatment emergent adverse event.
a
An adverse event is categorized as related if assessed by the investigator as possibly, probably, or very likely related to study agent.
b
Treatment discontinuation due to adverse event based on treatment disposition CRF page.
c
Time to CRS is the first occurrence of CRS event relative to the date of first dose of study agent.
d
This n refers to the number of CRS events in each group.