Table 2.
Safety summarya.
| | IPH5201 | IPH5201 + durvalumab 1,500 mg | Total (N = 57) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 100 mg (n = 3) |
300 mg (n = 3) |
1,000 mg (n = 13) |
3,000 mg (n = 19) |
Total (N = 38) |
300 mg (n = 4) |
1,000 mg (n = 8) |
3,000 mg (n = 7) |
Total (N = 19) |
||
| Any TEAEs, n (%) | 3 (100) | 3 (100) | 12 (92.3) | 18 (94.7) | 36 (94.7) | 4 (100) | 8 (100) | 7 (100) | 19 (100) | 55 (96.5) |
| Grade ≥3 TEAEsb | 1 (33.3) | 0 | 7 (53.8) | 9 (47.4) | 17 (44.7) | 1 (25.0) | 2 (25.0) | 3 (42.9) | 6 (31.6) | 23 (40.4) |
| Any TRAEs, n (%) | 1 (33.3) | 3 (100) | 8 (61.5) | 12 (63.2) | 24 (63.2) | 3 (75.0) | 5 (62.5) | 6 (85.7) | 14 (73.7) | 38 (66.7) |
| Related to IPH5201 | 1 (33.3) | 3 (100) | 8 (61.5) | 12 (63.2) | 24 (63.2) | 2 (50.0) | 5 (62.5) | 6 (85.7) | 13 (68.4) | 37 (64.9) |
| Related to durvalumab | NA | NA | NA | NA | NA | 3 (75.0) | 4 (50.0) | 4 (57.1) | 11 (57.9) | 11 (57.9) |
| Grade 3 TRAEs, n (%)b,c | 0 | 0 | 1 (7.7) | 3 (15.8) | 4 (10.5) | 1 (25.0) | 0 | 1 (14.3) | 2 (10.5) | 6 (10.5) |
| Related to IPH5201 | 0 | 0 | 1 (7.7) | 3 (15.8) | 4 (10.5) | 0 | 0 | 1 (14.3) | 1 (5.3) | 5 (8.8) |
| Related to durvalumab | NA | NA | NA | NA | NA | 1 (25.0) | 0 | 1 (14.3) | 2 (10.5) | 2 (10.5) |
| Treatment discontinuations | | | ||||||||
| Discontinued IPH5201, n (%) | 3 (100) | 3 (100) | 13 (100) | 19 (100) | 38 (100) | 4 (100) | 8 (100) | 7 (100)d | 19 (100) | 57 (100) |
| Due to AEs | 0 | 0 | 1 (7.7) | 1 (5.3) | 2 (5.3) | 0 | 0 | 1 (14.3) | 1 (5.3) | 3 (5.3) |
| Due to progressive disease | 3 (100) | 3 (100) | 12 (92.3) | 18 (94.7) | 36 (94.7) | 4 (100) | 8 (100) | 5 (71.4) | 17 (89.5) | 53 (93.0) |
| Discontinued durvalumab, n (%) | NA | NA | NA | NA | NA | 4 (100) | 8 (100) | 7 (100)d | 19 (100) | 19 (100) |
| Due to AEs | NA | NA | NA | NA | NA | 0 | 0 | 1 (14.3) | 1 (5.3) | 1 (5.3) |
| Due to progressive disease | NA | NA | NA | NA | NA | 4 (100) | 8 (100) | 5 (71.4) | 17 (89.5) | 17 (89.5) |
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
a
Data are shown based on the as-treated population, defined as all patients who received any investigational product.
b
AEs were graded according to NCI CTCAE v5.0.
c
There were no grade ≥4 TRAEs.
d
One patient discontinued because of withdrawal of consent.