Table 2.

Efficacy results of the ALTER0303 trial

Endpoint	Anlotinib arm (n = 294)	Placebo arm (n = 143)
OS (months, median [range])	9.46 (8.05–10.45)	6.37 (4.93–7.98)
HR (95% CI, P value)	0.70 (0.55–0.89, P = 0.002)
PFS (months, median [range])	5.37 (4.40–5.63)	1.40 (1.07–1.50)
HR (95% CI)	0.25 (0.19–0.31, P < 0.001)
ORR (CR + PR)	9.18%	0.70%
DCR (CR + PR + SD)	80.95%	37.06%

OS, overall survival; HR, hazard ratio; CI, confidence interval; PFS, progression-free survival; ORR, objective response rate; CR, complete response; PR, partial response; SD, stable disease; DCR, disease control rate