Replies to post #181306 on Biotech Values

[hirogen]

ONTY - All told - I'd interpret this PR as likely indication that the HR in the PR'd trial (EMR63325-009) is actually at least somewhat greater than 1.0

This would fit with the prior expected completion date in 2016 per CT.gov - I'm assuming there was a DSMB for this trial that saw HR going uncomfortably above 1 leading to a decision to stop the trial. What is also strange to me though is that the halt comes about 2 years after the last patient enrolled in the trial. The 8k wording says no difference in PFS, TTP, or AE, though it's not clear if numerically there was a trend.

They chose to focus future trials on the "Concurrent Chemo/Rad" subgroup of the START trial with a subgroup HR around 0.77 (from memory) - instead of the serum MUC (Tecmotide is a MUC vaccine) subgroup with a *much* better subgroup HR (and, obviously, a more justifiable MOA).

I remember looking at the smuc1 sub-group data (though I don't have the cite handy at the moment). Merck had looked at two bifurcation levels of smuc1 at ULN, which had a good HR, and let's say 1.5x ULN (don't recall exactly) which was much better. However I calculated that the treatment effect was entirelly driven by the >1.5x sub-group. Below that the HR was about 1, confining Stim benefit to roughly 20% of enrollment. Apparently Merck decided this was too large of a reduction in market size to be worth their while.

[DewDiligence]

Failed cancer vaccines might live again with checkpoint inhibitors:

http://www.reuters.com/article/2014/09/28/us-health-cancer-vaccines-idUSKCN0HN0BL20140928

Using vaccines to fight cancer is a field littered with failures but experts believe it is possible the approach could get a new lease of life if such shots are combined with a new class of drugs called checkpoint inhibitors.

…GSK threw in the towel on its [MAGE-A3] vaccine in April, dashing hopes for a project that was once seen as a potential multibillion-dollar sales opportunity in lung cancer and melanoma. Johan Vansteenkiste of Belgium's University Hospitals Leuven, who led research into use of MAGE-A3 in lung cancer, reported full results of the failure at [ESMO] on Sunday and said the setback was a clear disappointment.

But he thinks the new checkpoint inhibitors, which are designed to stop the molecular trickery that is used by tumor cells to escape detection by the immune system, could finally unlock the value of such vaccines.

…Roche Chief Executive Severin Schwan said earlier this month that the Swiss drugmaker…was already exploring ways of combining its checkpoint inhibitors with vaccines that had failed in tests when given on their own.