Table 3.

Antitumor activity of CDP-TubA in the H460 human non–small cell lung carcinoma xenograft model in nude mice

Group	Treatment regimen					Median	T-C	%TGD	Statistical significance*					MTV	Statistical significance^†					Regressions
Group		Agent	mg/kg	Schedule	TTE		T-C	%TGD		vs G1	vs G5	vs G6	Day 25	vs G1	vs G5	vs G6	PR	CR	TFS	Nadir	Deaths
1	Vehicle	—	qwk ×3	20.3	—	—	—	^‡	^‡	2144 ± 454	—	^‡	^‡	0	0	0	—	0
2	Tubulysin	0.025	qwk ×3	23.7	3.4	17	ns	^§	ns	1799 ± 834	ns	^‡	^‡	0	1	1	—	0
3	Paclitaxel	30	qod ×5	35.9	15.6	77	^‡	ns	ns	884 ± 388	^‡	^∥	ns	0	1	1	−17.5% Day 14	0
4	Vinblastine	8	qwk ×3	42.4	22.1	109	^§	ns	ns	752 ± 563	^‡	ns	ns	0	1	1	−6.7% Day 5	0
5	CDP-TubA	6	qwk ×3	52.3	32.0	158	^‡	—	^∥	144 ± 74.7	^‡	—	^∥	0	1	1	−7.9% Day 3	0
6	CDP-TubA	3	qwk ×3	43.2	22.9	113	^§	^∥	—	847 ± 441	^‡	^∥	—	0	0	0	−0.4% Day 4	0

NOTE: Potency was evaluated using log-rank testing on the time it took for individual tumors to reach a predetermined endpoint (TTE) of 2,000 mm³ and by comparing the mean tumor volume (MTV) for different treatment groups when tumors of vehicle treated animals reached 2,000 mm³ (day 25). Ten animals per group were treated. CDP-TubA (batch #2) doses are in tubulysin equivalents.
MTV, mean tumor volume ± SD (mm³) on the day the vehicle control group mean tumor volume reached the predetermined endpoint of 2,000 mm³.
↵* Statistical significance = Logrank test.
↵† Statistical significance = ANOVA w. Tukey's post test.
↵‡ P < 0.001.
↵§ P < 0.01.
↵∥ P < 0.05.