Skip to main content

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