Replies to post #91952 on Biotech Values

[p3analyze]

Thanks. From the Lancet oncology article, there does appear to be a a slight survival advantage of the 10 mg/kg over 3 mg/kg. This must have made it easy to "turf" the gp100 + 3 mg/kg ipi trial.

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(09)70334-1/abstract


Excerpt: Table 2 shows effi cacy data for every treatment group.
As the dose of ipilimumab increased, best overall response
rate rose (p=0·0015, trend test). Survival data are presented
in table 2 and fi gure 2. Hazard ratios for comparisons of
median overall survival between groups were as follows:
10 mg/kg versus 0·3 mg/kg, 0·770 (95% CI 0·525–1·130);
10 mg/kg versus 3 mg/kg, 0·875 (0·593–1·291);
and 3 mg/kg versus 0·3 mg/kg, 0·879 (0·604–1·279).
Subgroup analyses of best overall response rate and
overall survival, according to stratifi cation criteria, were
consistent with the main analyses (data not shown).

Excerpt:

The final population pharmacokinetic analysis provided
an adequate description of ipilimumab serum
concentration–time profi les (fi gure 3A). Model-based
simulation to assess achievement of the target trough
concentration of 20 µg/mL before the fourth (and last)
dose in the induction phase indicated that the target
concentration was expected to be exceeded by about 95%
of patients in the 10 mg/kg group, but by only 30% and
0% in the 3 mg/kg and 0·3 mg/kg groups, respectively
(fi gure 3B).