Avid Bioservices Inc (CDMO)

[mojojojo]

Here's some commentary from the avastin phase 3 1st-line NSCLC trial.

Statistical Analysis
The original study design called for the enrollment
of a total of 640 patients, with the final analyses
to be performed after 500 deaths had occurred.
The design included two planned suspensions of
recruitment for the safety analysis after a total
of 112 patients had been enrolled and then after a
total of 336 patients had been enrolled and planned
interim analyses of survival after 218 and 350
deaths had occurred. The plan to suspend recruit-
ment after enrollment of 336 patients was elimi-
nated in August 2003, on the basis of the recom-
mendation by the data monitoring committee;
in January 2004, the planned enrollment was in-
creased to 842 patients, with a planned final
analysis after 650 deaths had occurred, to target
a smaller treatment effect than that in the original
study design. The increase in accrual was based on
a recommendation by the ECOG Lung Committee,
which was unaware of the results of the efficacy
analysis. The revised design yielded an 80.5%
power of the study to detect a hazard ratio for
death of 0.80 in the group treated with chemo-
therapy plus bevacizumab, with the use of a one-
sided test and an overall type I error of 2.5%.

Efficacy Analysis
The median overall survival was 12.3 months in
the paclitaxel-carboplatin-bevacizumab group, as
compared with 10.3 months in the paclitaxel-
carboplatin group (hazard ratio for death, 0.79;
95% CI, 0.67 to 0.92; P = 0.003) (Fig. 2A).

It looks like their original trial design wasn't going to exceed their predetermined HR goal so they had to increase patient enrollment to make it happen. Their revised goal for the HR was .80 and they ended up just getting it with a HR of .79.

All IMO,

mojo