Table 4.

Primary endpoint and outcome of the pivotal trials between domestic and imported drugs.

End Point or Outcome	Domestic, (n = 21)	Imported, (n = 27)	P value
Primary trial end point, No. (%)
PFS	7 (33)	11 (41)	0.42
OS	3 (14)	3 (11)
ORRa	9 (43)	5 (19)
PFS and OS	2 (10)	4 (15)
DFS	0 (0)	2 (7)
MFS	0 (0)	1 (4)
TTP	0 (0)	1 (4)
Efficacy
Objective response rate, %b
Mediana(IQR)	57 (17, 69)	62 (47, 62)	0.77
Pooled estimate (95%CI)d	37 (22, 64)	48 (30, 77)	0.51
Progression-free survivalc
Gain, months, median (IQR)	9.0 (7.0, 10.1)	11.0 (7.9, 16.5)	0.24
Pooled hazard ratio (95%CI)d	0.51 (0.41, 0.63)	0.48 (0.44, 0.52)	0.64
Clinically meaningful improvement, No. (%)	4 (50)	12 (86)	0.14
Overall survivalc
Gain, months, median (IQR)	9.3 (9.0, 10.7)	10.6 (8.8, 18.1)	0.66
Pooled hazard ratio (95%CI)d	0.71 (0.64, 0.79)	0.66 (0.61, 0.73)	0.38
Clinically meaningful improvement, No. (%)	1 (33)	3 (80)	0.46
Safetyc
SAE, No. patients (%)	646/2783 (23)	1328/5566 (24)	0.41
SAE, Pooled Relative Risk (95%CI)d	1.40 (1.08, 1.83)	1.18 (1.07, 1.31）	0.23
Grade≥3 AEs, No. patients (%)	1480/2504 (59)	4201/7385 (57)	0.45
Grade≥3 AEs, Pooled Relative Risk (95%CI)d	1.61 (1.03, 2.51)	1.57 (1.21, 2.03)	0.92

IQR, interquartile range; CI, confidence interval; SAE, serious adverse events; PFS, progression-free survival; OS, overall survival; ORR, objective response rate; DFS, disease-free survival; MFS, metastasis-free survival; TTP, time to progress; AE, adverse events.

^aOnly one pivotal clinical trial was a randomized controlled clinical trial design, and all others were single-arm designs.

^bObjective response rate (ORR) included partial response and complete response. Only ORR reported in single-arm clinical trials were analyzed.

^cData for these analyses were derived from randomized controlled clinical trials (not included for single-arm trial designs).

^dResults from meta-analyses.