Overview of pembrolizumab immunogenicity findings
| 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%) |
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
aIncluded are patients with at least 1 ADA sample available after treatment with pembrolizumab
bInconclusive patients are the number of patients with no positive ADA samples and the drug concentration in the last sample above the DTL
cEvaluable patients are the total number of negative and positive patients (non–treatment emergent and treatment emergent)
dDenominator was total number of evaluable patients, highlighted in bold