Table 5 Incidence of ADAs by visit and overall (safety population)a

From: Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer

Visit

ADA status

PF-05280014

Trastuzumab-EU

Cycle 1

Patients assessed, n

113

112

Negative < 1.00, n (%)

113 (100.00)

110 (98.21)

Positive ≥ 1.00, n (%)

0

1 (0.89)

Not analysed, n (%)

0

1 (0.89)

Cycle 2

Patients assessed, n

111

112

Negative < 1.00, n (%)

111 (100.00)

112 (100.00)

Positive ≥ 1.00, n (%)

0

0

Cycle 4

Patients assessed, n

108

109

Negative < 1.00, n (%)

108 (100.00)

109 (100.00)

Positive ≥ 1.00, n (%)

0

0

Cycle 6

Patients assessed, n

108

108

Negative < 1.00, n (%)

108 (100.00)

108 (100.00)

Positive ≥ 1.00, n (%)

0

0

Overall

Patients assessed, n

113

112

Negative < 1.00, n (%)

113 (100.00)

111 (99.11)

Positive ≥ 1.00, n (%)

0

1 (0.89)

  1. aPercentages are based on the number of patients assessed at each visit. The unit of ADA titre was endpoint titre. Only predose assessments are summarised.
  2. ADA = antidrug antibody; trastuzumab-EU = licensed trastuzumab sourced from the European Union