Skip to main content

Table 2 Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) reported in patients treated with immune checkpoint inhibitor mAbsa

From: Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics

mAb Patients N, regimen, tumor type ADA assay ADA % NAb % Reference Year
Anti-PD-1
Nivolumab N = 1086, pool of 6 clinical studies ECL 12.7 0.8 Agrawal et al. 2017
N = 2085 ECL 11.2 0.7 US PI 2018
Nivo 3 mg/kg followed by ipi 1 mg/kg Q3W NR 23.8-26
ADA to nivo
0.5–1.9
nivo NAb
US PI 2018
Nivo 1 mg/kg followed by ipi 3 mg/kg Q3W NR 37.8
ADA to nivo
4.6
nivo NAb
US PI 2018
Nivo followed by ipi NR 4.1–8.4
ADA to ipi
0–0.3
ipi NAb
US PI 2018
Pembrolizumab N = 1087 ECL 1.7 NR Van Vugt et al. 2016
NSCLC ECL 2.5 NR Van Vugt et al. 2016
melanoma ECL 0.7 NR Van Vugt et al. 2016
N = 1289b ECL 2.1 0.5 US PI 2018
Cemiplimab N = 398 ECL 1.3 NR US PI 2018
Anti-CTLA-4
Ipilimumab N = 1024, melanoma ECL 1.1 0 US PI 2018
N = 144, melanomac ECL 4.9 0 US PI 2018
Nivo and ipi, N = 499, RCC and mCRC NR 5.4
ADA to ipi
0
ipi NAb
US PI 2018
N = 31, melanoma Bead-based assay 26 NR Knerveland et al. 2018
Anti-PD-L1
Atezolizumab N = 2007 NR 39.1 NR EMA 2017
N = 111 (cohort 1), urothelial carcinoma NR 48 NR US PI 2018
N = 275 (cohort 2), urothelial carcinoma NR 42 NR US PI 2018
N = 565, NSCLC NR. 30 NR US PI 2018
Avelumab N = 1558 NR 4.1 NR US PI 2017
N = 1738d NR 5.9 NR EMA 2017
Durvalumab N = 1570 NR 2.9 NR US PI 2018
Durvalumab + tremelimumab, N = 60 ECL 6.6
ADA to durva
NR Antonia et al 2016
Durvalumab + tremelimumab, N = 53 ECL 1.8
ADA to trem
NR Antonia et al 2016
  1. ADA anti-drug antibody, durva durvalumab, CTLA-4 cytotoxic T-lymphocyte associated protein 4, ECL electrochemiluminescent bridging assay, EMA European Medicines Agency, ipi ipilimumab, mAb monoclonal antibody, mCRC metastatic colorectal cancer, NHL non-Hodgkin lymphoma, NAb neutralizing antibody, nivo nivolumab, NR not reported, NSCLC non-small-cell lung cancer, PD-1 programmed death 1, PD-L1 PD-ligand 1, Q2W every 2 weeks, Q3W every 3 weeks, RCC renal cell carcinoma, trem tremelimumab, US PI United States product information
  2. aAll mAbs were administered intravenously
  3. bAnalysis performed in patient samples with concentrations below the drug tolerance level of the ADA assay
  4. cADA assessed using an ECL assay with improved drug tolerance
  5. dAssay performed with a cut point known to provide adequate assay sensitivity and drug tolerance level