Replies to post #65562 on Avid Bioservices Inc (CDMO)

[pphmtoolong]

The test was a signal seeking trial in a third world country fostered by a company that has skated along the edge of bankruptcy for years. The only realistic purpose of this trial was to learn whether the company had a future, period. The results were good enough; PPHM is still here today and is now doing meaningful trials.

Criticizing those trials is looking at the rear view mirror; the real action can only be viewed through the windshield where we will see if PPHM continues to move forward or hits a brick wall.


Paul

[cjgaddy]

Disagree, JR. The decision to go with less chemo (175mg-v-200mg & AUC5-v-AUC6) in the signal-seeking was clearly intentional, and to me showed confidence they could match/exceed Avastin/E4599 in a way that would be viewed very favorable from side-effects/patient tolerability views. And, now we know, Bavi+CP did match/exceed Avastin+CP in 1st-line NSCLC, albeit with n=49 and India-based. They did go back to the higher 200mg/AUG6 CP levels in the ongoing Ph2b Bavi+CP Frontine-NSCLC n=80 confirmatory trial ( http://clinicaltrials.gov/ct2/show/NCT01160601 ), but I hope when the dust settles and Bavi gets approved, the label specifies the lower chemo levels – heck, maybe they can go even lower. As far us treating Sicker patients in the signal-seeker, hey, that’s Great – like FFox said, just gives us a ‘cushion’ going into the Ph.2 n=120 2ndline NSCLC registration trial ( http://clinicaltrials.gov/ct2/show/NCT01138163 ), which remember, is Bavi+Doce, not Bavi+CP. Recall Steve King saying on 3-17-10, ”we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval.”

 
 = = = = = = = = = = = = = = = = = = 
 Result      CP-Only(n=444)     Avastin+CP(n=434)    Bavi+CP(n=49) 
 Obj. Resp.      15%                 35%                43% 
 Median PFS     4.5mos              6.2mos             6.1mos 
 MOS           10.3mos             12.3mos            12.4mos

• The Bavi+CP results were accomplished using less chemo (175mg-v-200mg & AUC5-v-AUC6) than used in the Avastin+CP trial.
• The Bavi+CP results were accomplished despite including harder-to-treat Squamous patients (8/49=16%; they yielded ORR=25%), totally excluded in the Avastin+CP trial.
• The Bavi+CP results were accomplished despite treated a higher % of sicker frontline-NSCLC patients (6%/ECOG0, 94%/ECOG1) than were treated in the Avastin+CP trial (40%/ECOG0, 60%/ECOG1.