Avid Bioservices Inc (CDMO)

[cjgaddy]

Mojo, I still can’t get that Bavi/NSCLC “1 C.R.” out of my mind, from early on (4 of 6 3-wk cycles) in the Bavi+CP/NSCLC Ph.2 India trial. It was mentioned in this 2-4-09 PR, but never again:

2-4-09: PRELIM. DATA, 17 EVALUABLES AT 12WKS (4 OF 6 CYCLES)
“17 of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of 4 treatment cycles, with 6 patients achieving partial tumor responses and one patient achieving a complete tumor response, according to RECIST criteria.”
http://tinyurl.com/dlotdx

RECIST:
PR=Partial-Resp(30-99% Red.)
SD=Stable-Disease(29% Red.-19% Incr.)
PD=Progressive-Disease(20% or more Incr.)
OR=Obj-Resp(PR+CR)

Obviously, he fell back out of CR at some point. But, to where? (unless it was a new metastatic tumor developing, which means auto-PD) Cudda been he went from 100% (probably 9x% in actuality) reduction back to 70% reduction – if so, he’d have been reverted to PD (Prog.Disease), and deemed a study “Failure” per RECIST, right?

In your 11-1-09 #44083, you pointed out why just looking at that single PFS% number can be deceiving. You go to 90% reduction, and then back up by 20% FROM THAT POINT, and you’re considered PD, even though you’re still DOWN 80% Red. From your Orig. Tumor. Ie, they measure the %CHG from the LAST Size, not the ORIG. size. Somehow that doesn’t make sense (but what do I know?!). Given that early Bavi+CP C.R. in those 1st 21 Stage1 ADV./Metastatic NSCLC patients, does that imply that a high% of other Bavi patients went in that direction too? As compared to, say, what occurred in the comparable Avastin trial: Ph.2 Avastin+CP n=35: 31.5% ORR http://tinyurl.com/b3g4rf ? IF so, Bavi+CP’s 52% ORR so far (Stage1 n=21) in the India Ph.2 trial might bode well for Bavi Survivability, when they finally come out. Just something to think about – we won’t know the full picture until we get Survivability figures in that trial…

= = = = YOUR MOST INTERESTING POST ON THE SUBJECT of PFS%:
Mojo #44083 11-1-09: “In my opinion, PFS is a bogus “endpoint” that doesn't tell you squat.
EXAMPLE 1 [Orig.Tumor = 100mm]:
Patient “A” has a PR with a 90% reduction in tumor volume down to 10 mm. After 6 mos. of treatment the tumor volume increases to 12 mm and the patient qualifies as having a progressive disease.
Patient “B” has a PR with a 30% reduction in tumor volume down to 70 mm. After 6 mos. of treatment the tumor volume increases to 84 mm and the patient qualifies as having a progressive disease.
EXAMPLE 2:
Cohort “A” has a 64% OR rate and a 50% reduction in median tumor volume that increases to 60% of the original volume at 6.5 mos.
Cohort “B” has a 35% OR rate and a 0% reduction in median tumor volume that increases an additional 20% at 6.2 mos.”
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