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Table 1 Efficacy endpoint assessment results (ITT population)

From: Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab

Parameter

Group 1: BCD-022 (n = 113)

Group 2: Reference Trastuzumab (n = 110)

p-value

N

% (95% CI)

n

% (95% CI)

Primary outcome measure

 ORR

56

49.6 (40.08–59.07)

48

43.6 (34.31–53.41)

0.452a

Secondary outcome measure

 CR

4

3.5 (1.14–9.35)

2

1.8 (0.32–7.06)

0.683b

 PR

52

46.0 (36.69–55.62)

46

41.8 (32.6–51.61)

0.619a

 ST

28

24.8 (17.35–33.95)

21

19.1 (12.46–27.93)

0.388a

 PD

25

22.1 (15.08–31.10)

28

25.5 (17.84–34.81)

0.670a

  1. Note: ORR overall response rate, CR complete response, PR partial response, ST stabilization, PD progressive disease, NER non-evaluable response
  2. a Pearson’s χ2-test with Yates correction, b exact Fisher’s test