Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab

Table 2 Efficacy endpoints assessment results (pooled mITT population)

Parameter	BCD-021 (N=205) N% (95% CI)	Reference bevacizumab (N=136) N% (95% CI)	p-value
Primary outcome measure
ORR (confirmed)	7134.63 (28.46 - 41.38)	4633.82 (26.41 - 42.12)	0.8773²
Secondary outcome measure
CR rate (confirmed)	31.46 (0.5 - 4.21)	10.74 (0.13 - 4.05)	1.0000¹
PR rate (confirmed)	6833.17 (27.09 - 39.87)	4533.09 (25.74 - 41.37)	0.9874²
PR rate (unconfirmed)	52.44 (1.05 - 5.58)	42.94 (1.15 - 7.32)	0.7458¹
Stable disease	6531.71 (25.72 - 38.36)	4633.82 (26.41 - 42.12)	0.6830²
Progressive disease	2713.17 (9.21 - 18.48)	1511.03 (6.8 - 17.4)	0.5557²

Note: ORR – overall response rate; CR – complete response; PR – partial response; N = number of subjects in Analysis Set; n = number of subjects with responses. ¹ Fisher's exact test, ² Pearson's chi-squared test

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