Avid Bioservices Inc (CDMO)

[freethemice]

The expectations game. I am worried that we have gotten way ahead of ourselves for expectations
of MOS in the pancreatic and first-line NSCLC trials. We don't know anything about how both
arms have done in these trials and the comparison of the treatment arm MOS with the
control arm MOS is all that really matters. For both cases the historic data shows
little improvement in MOS when an experimental drug has been added to the standard chemo
used in the control arms. In first-line NSCLC adding Avastin to carboplatin + paclitaxel
increased MOS by only 20%. In pancreatic it has yet to be shown that adding another drug
to gemcitabine increases the MOS. There have been a few targeted drugs that work better
for small percentages of NSCLC patients with specific, and identifiable mutations,
but not for the general patient population. For pancreatic cancer the FOLFIRINOX regimen
works better than gemcitabine, but can only be used by the healthiest of patients
who can tolerate the side effects. This leads me to conclude that a 50% increase in MOS
would be an excellent outcome for bavi in both of these trials. The other thing to
remember is that both of these trials are relatively small. The first-line NSCLC trial
enrolled 86 patients, and the pancreatic trial enrolled 70 patients, and half of
the patients are in the control arms. That means that neither trial is likely to
have a MOS result that is statistically significant. If both trials have a 25-50%
increase in MOS I would consider them a great success and a validation of bavi,
and would support moving to phase III trials.
My point here is that I am trying to be more realistic so that even very good results
are not discounted because the expectations have become so large.