Replies to post #138264 on Biotech Values

[p3analyze]

>>we know the efficacy is not extraordinarily strong<<
Really? That really depends on how much alpha was allocated to IA2.

[DewDiligence]

ONTY’s Stimuvax fails phase-3 trial in Stage-III NSCLC:

http://finance.yahoo.com/news/emd-serono-phase-iii-trial-073200865.html

EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the Phase III START trial of its investigational product L-BLP25 (formerly referred to as Stimuvax) in patients with unresectable, locally advanced stage IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary endpoint to demonstrate a statistically significant improvement in overall survival (OS).

Despite not meeting the primary endpoint, notable treatment effects were seen for L-BLP25 in certain subgroups.

There they go again with data mining for subgroups, which is how the phase-3 START trial was created in the first place. For all practical purposes, however, Stimuvax—and the technology platform on which it is based—would appear to be dead.

The ongoing clinical program of L-BLP25 that includes studies in the Asia Pacific region will continue pending discussion with relevant regulatory agencies.

These studies will likely be shut down in due course, IMO.

p.s. The statistical features of the START trial have been debated on this board ad nauseam; the relevant posts can be found in the iHub archive.