Replies to post #161921 on Biotech Values

[DewDiligence]

Amgen tested T-Vec against subcutaneous GM-CSF, not against any of the current active agents.

Well, GM-CSF is not exactly inactive; in fact, a phase-2 study presented at ASCO showed that Leukine + Yervoy worked better than Yervoy alone (http://www.healio.com/hematology-oncology/highlights-from-asco-2013/gm-csf-plus-ipilimumab-extended-os-in-metastatic-melanoma ).

[iwfal]

AMGN and TVec -

The data for overall survival endpoint has not come close to maturing as a large percentage of the treated group are still alive but censored (as dead) for this second analysis. A quick look at the survival KM shows a very large cohort of survivors in the middle of the treated survival curve. It won't take very much time for these survivors to influence the HR and the p values as the trial matures. The slopes of the curves differ by more than 20% but the censoring of the survivors really influences the data in the middle of the curve.

Ok - but the survival data doesn't actually look all that good. May hit stat sig at survival, may not. Very borderline and not a particularly good HR - although almost certainly active in the disease.

I agree with Dew that the most interesting trial(s) will be those combining it with immune debraking treatments. Hopefully they allow better durability - thus translating the response endpoints into survival.