Replies to post #105218 on Avid Bioservices Inc (CDMO)

[cjgaddy]

FTM, thanks for your updated 1st-Line NSCLC C+P Ph.3 Table - I will link it into iBox later today. You are a treasure here.

[cjgaddy]

12-22-12: FTM’s updated historical 1st-Line NSCLC Ph.3 Results Table (iHub #105217) – see below. 15 Ph.3 trials. MOS for Chemo Alone (control) ran 8.1-13.0 mos. with mean of 10.0 mos. MOS for Treatment arms ran 7.8-13.4 mos. with mean of 10.2 mos. As FTM states, the highest %Improvement in MOS was CP vs. Avastin+CP/Sandler, 10.3=>12.3 mos. = 19.4%.

(((( MY BAVI+CP MOS EST. A/O 12-22-12: Enrollment for the ongoing randomized Bavi+PC Front-Line NSCLC trial [ http://clinicaltrials.gov/ct2/show/NCT01160601 ] went from 7-14-10 thru 9-8-11. Let’s very conservatively put the median 1st-dosing date for Pts at 6-15-11 [ie 50% B4 7/14/10- 6/15/11 (11mos.), 50% 6/15/11- 9/8/11(3mos)] . If ½ pts still alive today (ie, MOS not yet triggered, “time-to event”), then MOS in this trial is now around 18 mos. Jan’13 takes us to 19 mos. Feb’13 to 20 mos. etc etc. – all vs. historical norms of ~10 mos. for PC alone (see FTM table below). ))))

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http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82719478
FTM 12-22-12: “I have updated my table of Phase III 1st-Line NSCLC trials. There are now 15 included. All of them have control arms using carboplatin + paclitaxel, same as in the Bavi 1st-Line trial. I have highlighted in blue the maximums for each column. The Avastin trial still holds the record for largest % increase in MOS (19.4%). If the Bavi 1st-Line trial comes in with a control arm MOS of 13 mos. and a treatment arm MOS of 17 mos., it would be an increase of 31%, still very good in comparison.”


FTM’S FOLLOWUP COMMENTS IN #105218:
In the table of phase III 1st-Line NSCLC trials ,you can see that the Sandler et al trial (Avastin) and the Scagliotti et al trial (motesanib) both increased the MOS by 2 mos. in the treatment arms. In the Avastin case, this increase was statistically significant (P = 0.003) and in the motesanib case it was not (P = 0.14). Looking at the Kaplan-Meier curves gives an indication as to why this was so.
Sandler et al:

Scagliotti et al:

Motesanib is a "selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, 3; platelet-derived growth factor receptor; and Kit", which makes it similar to sorafenib.

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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
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as
…7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab."
...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl
……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.