TABLE 2.
Safety summary by ADA status (pooled safety study populations)
| Pooled atezolizumab monotherapya (n = 2706) | Pooled atezolizumab combination therapyb (n = 3666) | |||
|---|---|---|---|---|
| ADA– (n = 1704) | ADA+ (n = 1002) | ADA– (n = 2638) | ADA+ (n = 1028) | |
| Total number of AEs, n | 18,621 | 11,057 | 38,623 | 14,018 |
| Patients with ≥1 indicated AE, n (%) | ||||
| All AEs | 1643 (96.4) | 973 (97.1) | 2602 (98.6) | 1016 (98.8) |
| Treatment related | 1216 (71.4) | 705 (70.4) | 2447 (92.8) | 962 (93.6) |
| Atezolizumab related | 1216 (71.4) | 705 (70.4) | 1998 (75.7) | 790 (76.8) |
| Grade 3/4 AE | 757 (44.4) | 494 (49.3) | 1590 (60.3) | 635 (61.8) |
| Treatment related | 271 (15.9) | 156 (15.6) | 1306 (49.5) | 526 (51.2) |
| Atezolizumab related | 271 (15.9) | 156 (15.6) | 675 (25.6) | 286 (27.8) |
| Grade 5 AE | 52 (3.1) | 32 (3.2) | 90 (3.4) | 49 (4.8) |
| Treatment related | 2 (0.1) | 3 (0.3) | 26 (1.0) | 17 (1.7) |
| Atezolizumab related | 2 (0.1) | 3 (0.3) | 19 (0.7) | 12 (1.2) |
| Serious AE | 642 (37.7) | 425 (42.4) | 965 (36.6) | 447 (43.5) |
| Treatment related | 182 (10.7) | 111 (11.1) | 496 (18.8) | 254 (24.7) |
| Atezolizumab related | 182 (10.7) | 111 (11.1) | 340 (12.9) | 166 (16.1) |
| AE leading to any study treatment withdrawal | 114 (6.7) | 61 (6.1) | 507 (19.2) | 236 (23.0) |
| AE leading to atezolizumab withdrawal | 114 (6.7) | 61 (6.1) | 251 (9.5) | 136 (13.2) |
| AE leading to any dose modification or study treatment interruption | 470 (27.6) | 308 (30.7) | 1564 (59.3) | 641 (62.4) |
| AE leading to atezolizumab interruption | 470 (27.6) | 307 (30.6) | 1191 (45.1) | 491 (47.8) |
| Total number of AESIs, n | 1157 | 737 | 3005 | 1232 |
| Patients with ≥1 indicated AESI, n (%) | ||||
| All AESIs | 590 (34.6) | 365 (36.4) | 1410 (53.4) | 562 (54.7) |
| Treatment related | 431 (25.3) | 264 (26.3) | 1160 (44.0) | 463 (45.0) |
| Atezolizumab related | 431 (25.3) | 264 (26.3) | 1063 (40.3) | 428 (41.6) |
| Grade 3/4 AESI | 124 (7.3) | 80 (8.0) | 282 (10.7) | 149 (14.5) |
| Treatment related | 91 (5.3) | 53 (5.3) | 223 (8.5) | 107 (10.4) |
| Atezolizumab related | 91 (5.3) | 53 (5.3) | 201 (7.6) | 102 (9.9) |
| Grade 5 AESI | 1 (<0.1) | 1 (<0.1) | 12 (0.5) | 4 (0.4) |
| Treatment related | 0 | 1 (<0.1) | 10 (0.4) | 4 (0.4) |
| Atezolizumab related | 0 | 1 (<0.1) | 10 (0.4) | 4 (0.4) |
| Serious AESI | 83 (4.9) | 43 (4.3) | 180 (6.8) | 90 (8.8) |
| Treatment related | 73 (4.3) | 33 (3.3) | 146 (5.5) | 72 (7.0) |
| Atezolizumab related | 73 (4.3) | 33 (3.3) | 138 (5.2) | 70 (6.8) |
| AESI leading to any study treatment withdrawal | 34 (2.0) | 16 (1.6) | 127 (4.8) | 52 (5.1) |
| AESI leading to atezolizumab withdrawal | 34 (2.0) | 16 (1.6) | 108 (4.1) | 48 (4.7) |
| AESI leading to any dose modification or study treatment interruption | 109 (6.4) | 78 (7.8) | 335 (12.7) | 146 (14.2) |
| AESI leading to atezolizumab interruption | 109 (6.4) | 78 (7.8) | 292 (11.1) | 127 (12.4) |
| AESI requiring the use of systemic corticosteroids | 123 (7.2) | 84 (8.4) | 365 (13.8) | 161 (15.7) |
Abbreviations: ADA, anti‐drug antibodies; AE, adverse event; AESI, adverse event of special interest.
a
The pooled atezolizumab monotherapy population comprised patients enrolled in the atezolizumab monotherapy cohorts or experimental arms of the following studies: POPLAR, OAK, IMvigor211, FIR, BIRCH, IMvigor210, and PCD4989g.
b
The pooled atezolizumab combination therapy population comprised patients enrolled in the atezolizumab‐containing experimental cohorts or arms of the following studies: IMpower130, IMpower132, IMpower131, IMpower150, IMpower133, IMmotion151, IMpassion130, IMbrave150, and GO30140.