Biotech Values

[iwfal]

ONTY -

randomized Phase 1/2 study, EMR 63325-009, of tecemotide compared to placebo in Japanese patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival

This is an odd PR:

1) It was a tiny trial (205 patients - see here) by any oncology standards - but especially so given that even the post hoc subgroup of START (the big ph 3 that failed last year) was too small to be reliably seen even in a trial 3x as big as the one being PR'd today.

2) One of the most reliable subgroups in START (seen in two different post hoc slice-and-dices) was that the Asian patients actually did *worse* on Tecemotide. Ordinarilly I'd largely dismiss this factoid (the negative effect seen in two different Asian subgroups) - but it is well known that Asian NSCLC patients behave very differently than non-Asians.

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 (you don't consider cancelling because a trial tha is <1/3 the size it would need to be results in an HR=0.90 - too much chance it was just bad luck).

BTW - The path forward that Merck Kga has chosen for Tecmotide is classic old Big Pharma. 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 assume they were using BP logic of "bigger patient population is a better market even if HR very waterred down". Idiocy IMO - and surprised that such a decision was still made in 2013 when the move to targetted therapies was in full swing.