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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