Biotech Values

[mcbio]

I mentioned before that I would not find it surprising if the overall survival endpoint was not met, due to the size of the study. Nonetheless, I'm looking forward to seeing the full results whenever they are presented.

I completely agree with you. While it's too bad we didn't hit the homerun that would have been stat sig improvement on OS in this small, 87 patient Phase 2 trial, the results to me suggest we have an active drug. Stat sig in favor of the selumetinib arm on all secondary endpoints, including PFS, ORR, and alive and progression-free at 6 months. And we know the selumetinib arm outperformed the control on OS, just not stat sig. The question is just how active is the drug? We need to see the full results from this trial to get a better read on them. How close to stat sig was selumetinib in this small trial? What do the curves look like? Is it conceivable AZN can show stat sig benefit for selumetinib on OS in a much larger 500 or 1000 patient Phase 3 trial if these results were to be replicated in Phase 3? I.e., are the results robust enough and it's just a question of testing selumetinib in a much bigger trial? I think the full results will help give us at least somewhat of a better idea on the magnitude of these results but I don't see how they're not encouraging, at an absolute minimum.

And given that KRAS NSCLC patients represent an unmet medical need, is it an absolute certainty that AZN will be required to demonstrate an OS benefit of selumetinib in Phase 3 or will it suffice if they are able to reproduce these results in Phase 3 (i.e., stat sig PFS, ORR, and PF at 6 months)? I assume they will still need to demonstrate an OS benefit but just throwing out for discussion since there really aren't any other effective options for these patients.

Separately, let's not forget that NVS is testing its own MEK partnered with ARRY in combo with other targeted agents, which could lead to even more robust results than what is produced when MEKs are tested in combo with chemo.

The melanoma combo data is up next.