AI
Friday, September 14, 2012 12:29:33 PM
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
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
