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Table 1 Overview of pembrolizumab immunogenicity findings

From: Immunogenicity of pembrolizumab in patients with advanced tumors

Pembrolizumab in the nonadjuvant setting: melanoma, NSCLC, HNSCC, CRC, HL, UC
Stratified by treatment All treatments Treatment   
2 mg/kg Q3W 10 mg/kg Q3W/Q2W 200 mg Q3W   
 Immunogenicity status
 Assessable patientsa 3655 667 2007 981   
 Inconclusive patientsb 1655 125 1462 68   
 Evaluable patientsc 2000 542 545 913   
  Negatived 1943 (97.2%) 527 (97.2%) 529 (97.8%) 887 (97.2%)   
  Non–treatment-emergent positived 21 (1.1%) 7 (1.3%) 4 (0.7%) 10 (1.1%)   
   Neutralizing negative 19 (1.0%) 5 (0.9%) 4 (0.7%) 10 (1.1%)   
   Neutralizing positive 2 (0.1%) 2 (0.4%)     
  Treatment-emergent positived 36 (1.8%) 8 (1.5%) 12 (2.2%) 16 (1.8%)   
   Neutralizing negative 27 (1.4%) 6 (1.1%) 11 (2.0%) 10 (1.1%)   
   Neutralizing positive 9 (0.5%) 2 (0.4%) 1 (0.2%) 6 (0.7%)   
Stratified by indication Melanoma NSCLC HNSCC CRC HL UC
 Immunogenicity status
 Assessable patientsa 1465 1236 101 54 220 579
 Inconclusive patientsb 1063 445 39 0 38 70
 Evaluable patientsc 402 791 62 54 182 509
  Negatived 395 (98.3%) 762 (96.3%) 59 (95.2%) 51 (94.4%) 179 (98.4%) 497 (97.6%)
  Non–treatment emergent positived 4 (1.0%) 6 (0.8%) 2 (3.2%) 2 (3.7%) 2 (1.1%) 5 (1.0%)
   Neutralizing negative 3 (0.7%) 5 (0.6%) 2 (3.2%) 2 (3.7%) 2 (1.1%) 5 (1.0%)
   Neutralizing positive 1 (0.2%) 1 (0.1%)     
  Treatment emergent positived 3 (0.7%) 23 (2.9%) 1 (1.6%) 1 (1.9%) 1 (0.6%) 7 (1.4%)
   Neutralizing negative 2 (0.5%) 18 (2.3%) 1 (1.6%) 1 (1.9%)   5 (1.0%)
   Neutralizing positive 1 (0.2%) 5 (0.6%) 0 0 1 (0.6%) 2 (0.4%)
  1. ADA Antidrug antibody, CRC Colorectal carcinoma, DTL Drug tolerance level, HL Hodgkin lymphoma, UC Urothelial cancer, NSCLC Non–small cell lung carcinoma, HNSCC head and neck squamous cell carcinoma, NSCLC Non–small cell lung carcinoma, Q2W every 2 weeks, Q3W every 3 weeks, UC urothelial carcinoma
  2. aIncluded are patients with at least 1 ADA sample available after treatment with pembrolizumab
  3. bInconclusive patients are the number of patients with no positive ADA samples and the drug concentration in the last sample above the DTL
  4. cEvaluable patients are the total number of negative and positive patients (non–treatment emergent and treatment emergent)
  5. dDenominator was total number of evaluable patients, highlighted in bold