Replies to post #273032 on Avid Bioservices Inc (CDMO)

[JamesGMS]

Hello Ent, re your post excerpted in relevant part below:

We see statistically significant differences in many instances that do not translate into a cost-effect significant improvement in quality of life. In other words, OS might be extended from 6 months to 8 months, which might attain statistical significance, but is not a marketable difference in treatment.

Remember we agree on your issue re treating advanced lung cancer - but I do have to take serious exception to your statement highlighted above in red - as we've discussed before, we are dealing with incremental improvements to the treatment of all kinds of cancers - and no, they of course do not offer a cure and in most cases not even a truly significant improvement to quality of life - but to say they do not present a "marketable difference in treatment" is quite simply incorrect - the most recent example of course being BMY receiving accelerated approval for NSCLC for just a two month improvement in MOS - so "incremental" is most certainly "marketable."

Enjoy the rest of your day.

James

[hopefilled2014]

Thanks entdoc. I know enough that extending OS by two months can be stat sig especially in advanced lung cancer but not for a major bump, especially if not cost effective/quality of life. Got it. Sooooo, does Peregrine go to Europe to announce a 2 month extension of OS for this dreadful disease? Is that a big enough deal to bend the ears of these top-flight oncologist /researchers? I really have no idea. I know you're not with PPHM but you're a link to the operating room and have seen drugs come and go for those stage 4 cancers. That's why I ask.

And what about stage 1 and 2 lung cancer? Maybe "we" can't take out the battleship but how about a destroyer (old navy man)?

Look entdoc, we have clever posters that appear to be "entdocs" and know the lingo, but may never have used a band-aid correctly. You're the real deal and what's more, know the score.

Thanks for tolerating an amateur!

[BioBS2012]

In other words, OS might be extended from 6 months to 8 months, which might attain statistical significance, but is not a marketable difference in treatment.

Personally, I would be very interested to see how the OS data compares with the Nivolumab data versus Docetaxel.
http://www.nejm.org/doi/full/10.1056/NEJMoa1507643#t=abstract
Also of interest is the late-breaking abstract for Phase III data from Roche/Genetech's Atezolizumab versus docetaxel, which is being presented at ESMO a day earlier. For reference, here are the Phase II #'s
Overall survival in the intention-to-treat population was 12·6 months (95% CI 9·7–16·4) for atezolizumab versus 9·7 months (8·6–12·0) for docetaxel (hazard ratio [HR] 0·73 [95% CI 0·53–0·99]; p=0·04).
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(16)00587-0.pdf

As far as a biomarker, is it something detectable by a blood test, or will it require biopy of the tumor during treatment?

Given that they mentioned having collected 1000's of samples from SUNRISE alone, one can surmise that this biomarker is detectable by a blood test. IMO.

Cheers.

[Protector]

entdoc, that question is answered in PPHM's PR:

For instance, what percentage of patients showed the improvement? How much improvement?

The answer is : a sufficient large sample of BOTH arms in order to be able to come to the conclusion that there is statistical relevance.

So it is impossible that we are talking about 10 or 20 patients given the scale of the clinical trial in which it was observed.

And believe me, in Lung Cancer an over-all survival of end-points that have been designed for the drug to become SOC (Standard of Care) is commercially marketable.

In other words, OS might be extended from 6 months to 8 months, which might attain statistical significance, but is not a marketable difference in treatment.

Look at Opdivo alone, as you will see it performed LESS GOOD then bavituxmab+docetaxel and yet at 150K$ per full treatment people go for this drug that delays their death (yet will come back within a window of abou 12 to 36 months.

With bavituximab you have an immune response.