Biotech Values

[jq1234]

In the IC arm, the median OS of the 5 HG non TN patients was ~11.3 months vs 5.5 months for the 6 HG TN patients. I find It hard to believe in the 5th or 6th line setting the type of chemo or TN status still makes such a big difference. Patients at this stage would be too refractory regardless of TN status. I am not sure whether it's correct to characterize chemo given to non-TN as active vs that to TN as placebo.

Those 5 HG non TN you picked had the best OS among ALL IC patients in the trial. Obviously you can look at this two different ways:

1. High G and TN IC arm represented underperformers in the trial, thus exeggerate 011 OS survival in this group - graph 4.

2. Even with super performers on HG IC arm like that with small smaple size, there is still strong OS trend for 011 over IC for high G group. Thus, it highlights G status as predictor of outcome - graph 3.

To look at 1 further, if you look at TN regardless of G status for IC arm (graph 2) - it is reasonable to look at this under the assumption that IC arm results don't change much due to G status - mOS=6.5, it is still underpormed the overall IC arm mOS=7.4. It is consistent with the assumption that TN status is negative indicator of outcome in IC arm. So even if in larger sample, high G and TN IC arm perform better than IC arm in graph 4, it doesn't contradict/invalidate the overall result in graph 3 and 4. To me, the question is how large a sample size is needed to confirm the benefit.