Replies to post #92296 on Avid Bioservices Inc (CDMO)

[Robert C Jonson]

I do not necessarily think that the 1st line control group hasn't evented is correct. IMO management does not have to PR the control group eventing and has not inany other trial except the double blinded 2nd line trials.

Geo, you may be correct, but that's not what Chris Keenan told me:


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78867646

[cjgaddy]

I’m quite certain we’ll get an update as soon as MOS is reached for the Bavi arm in the randomized Bavi+PC vs. PC 1st-Line NSCLC trial [ http://clinicaltrials.gov/ct2/show/NCT01160601 ]. The latest confirmation of that is per the updated 9-12-12 Fact Sheet – note that “MOS Data” for the 1st-Line NSCLC trial (est. Q4’12 – Q1’13) carries this note: “Event driven milestone reported once MOS is reached.”

I agree that I don’t think they’ll report Ctl-Arm (PC) MOS when reached – my guess is it already has.



Key to me about the 1st-Line trial is that it actually completed enrollment one month earlier than the 2nd-Line trial (9-8-11 vs. 10-6-11). And, if frontline doesn’t trigger MOS in the Bavi Arm (remember, there’s only one Bavi arm in this trial: 3mg) until, say Dec’12, then we’ve gotta be looking at MOS in the 14-16 mos. range for the Bavi arm. And, 14-16 mos. would compare extremely favorably with Historical Front-Line MOS results (see below, ex: Avastin E4599 = 12.3mos).

We just don’t know how 14-16 MOS for the Bavi+PC arm will compare to the PC/Ctl-Arm MOS, which came in with abnormally high ORR & PFS in the 3-9-12 Topline press release ( http://tinyurl.com/7m9r6ya ) - will ctl. follow suit with high MOS as well?…

IN THE PRIOR FRONT-LINE NSCLC SINGLE-ARM TRIAL:
Ph.2 Bavi+PC/NSCLC/Frontline (India n=49, 6/2008-10/2009): ORR=43%, PFS=6.1mos, MOS=12.4mos
Compare Bavi’s MOS=12.4mos to P+C/alone=10.3 mos., Avastin+PC=12.3 mos. (E4599/n=434), achieved using less Chemo (175-v-200 & AUC5-v-AUC6), treating 16% (8/49) more-difficult Squamous in Bavi trial (excluded totally from E4599), and treating higher % of sicker ECOG1 patients than in E4599 (96%-v-60%). See 6-15-11/PR http://tinyurl.com/3fcz5ok , ASCO'10 http://tinyurl.com/2g5cqof , and a discussion of differentiating factors between patient demographics and baselines treated in the 2 trials: http://tinyurl.com/6k5uuf7 .

= = = = = = = = = = = = = = = = = = =
AVASTIN E4599 => Avastin+CP MOS=12.3mos. (n=434):
http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884


= = = = = = = = = = = = = =
G. Phase IIb Bavi+PC vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory', n=86)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11)
...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402
...3-9-12: Topline ORR & PFS Data (Bavi+PC vs.PC-only) http://tinyurl.com/7m9r6ya
…...LOCAL reads: ORR/32%-31% PFS/5.8-4.6mos , CENTRAL reads: ORR/25%-23% PFS/6.7-6.4mos
...12-6-11 Prelim. Data (n=86, 100% Stage IV's) => ORR=39%, PC/alone=25%: http://tinyurl.com/7ph4tty
......Comp. vs. Avastin+PC/Ph3/n=417(74% Stage IV's): ORR=35% (Sandler/E4599/2006 http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884 )
...9-8-11: Enrollment complete. http://tinyurl.com/3vv9zfx