Table 2.
Summary of treatment-emergent ADA incidence by treatment (in trials with largest sample sizes)
Treatment | No of trials identified | Reported incidence (%) of ADAs | Range (%) of reported incidence of nAbs | ||
Range | Incidence in largest sample size (n) (ref) | Incidence in FDA package insert (n) (ref) | |||
CTLA-4 inhibitors | |||||
Ipilimumab | 12 | 0–26 | 1.1 (1024)61 | 1.1 (1024)61
5.4 (499) 8.5 (483) |
0–1.6 |
Tremelimumab | 4 | 3.98–71.4 | 3.98 (377)96 | NA | NR |
PD-1 inhibitors | |||||
Avelumab | 13 | 0–39.9 | 4.4 (1609)49 | 4.1 (1558)56
15 (453) |
0–3.6 |
Cemiplimab | 6 | 0–2.6 | 2.6 (39)51 | 2.2 (823)58 | 0 |
Dorsalimab | 1 | 2.5–3.7 | 3.7 (349)40 | 2.5 (315)59 | 2.0 |
JTX-4014 | 1 | 0 | 0 (18)43 | NA | NR |
Nivolumab | 27 | 0–42.9 | 12.7 (1086)20 | 11.2 (2085)57 | 0–2.8 |
Pembrolizumab | 31 | 0–20 | 1.8 (2000)48 | 2.1 (1289)54 1.8 (2034) | 0–0.7 |
Pucotenlimab | 1 | 3.3 | 3.3 (30)39 | NA | NR |
Sasanlimab | 1 | 8.6 | 8.6 (35)34 | NA | 0 |
Sintilimab | 4 | 0–1.05 | 0.52 (381)46 | NA | 0–1.05 |
PD-1 inhibitors | |||||
Atezolizumab | 31 | 0–54.1 | 29.6 (639)44 50 | 28 (241)55 | 4.3–27.5 |
Durvalumab | 14 | 0–74 | 0 (416)98 | 2.9 (1,570)60 | 0–0.9 |
LY3415244 | 1 | 100 | 100 (12)31 | NA | NR |
Lodapolimab | 1 | 17 | 17 (65)52 | NA | 11 |
Combination therapies | |||||
Durvalumab+tremelimumab | 6 | 0–9.6 | 9.6 (293)93 | NA | 0.4–1.0 |
0–18.5 | 18.5 (293)93 | 11.4–17.1 | |||
Ipilimumab+nivolumab | 2 | 2.4–9.3 | 2.4 (86)73 | NA | 0 |
27.3–39.4 | 27.3 (154)95 | 1.95 | |||
Durvalumab+MEDI0680 | 1 | 5.1 | 5.1 (39)83 | NA | NR |
5.1 | 5.1 (39)83 |
ADA, antidrug antibody; FDA, Food and Drug Administration; NA, not applicable; nAb, neutralizing antibody; NR, not reported; PD-1, programmed cell death protein 1.