AI
Saturday, September 15, 2012 12:24:12 PM
Bob, re: your, “So I still think there is a good chance the control MOS hasn't been reached. Wouldn't that be normal for a 1st line NSCLC trial where the patients aren't so sick to begin with?”
Look at the MOS reported for the P+C/Alone arm in this Avastin trial:
(P+C = Paclitaxel + Carboplatin)
AVASTIN E4599/n=434 Ph.III Trial in Front-Line NSCLC:
• P+C/alone = 10.3 mos.
• Avastin+PC=12.3 mos.
From: http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884
Thus, the reason I don’t think it’s normal for MOS to still be accruing in the P+C Ctl-Arm is that MOS for that regimen historically is in the 10-11 mo. range. BUT, we’re now at about the 14-15 months point for MOS in our Front-Line trial – see below…
Given that our 1st-Line NSCLC trial completed enrollment 9-8-11 (which puts us now at a minimum in the 14-15 mos range from median enrollment date) and that historical MOS for P+C/Alone is in the 10-11 mos. range, I believe Ctl-Arm MOS has been reached (despite their abnormally high ORR & PFS numbers reported 3-9-12), and both Bavi arms are still accruing MOS. If the Bavi arms hold until Nov/Dec, we’re really looking at a heckava MOS advantage for Bavi 1st-Line, just like we saw in 2nd-Line on Sept7.
Look at the MOS reported for the P+C/Alone arm in this Avastin trial:
(P+C = Paclitaxel + Carboplatin)
AVASTIN E4599/n=434 Ph.III Trial in Front-Line NSCLC:
• P+C/alone = 10.3 mos.
• Avastin+PC=12.3 mos.
From: http://www.nejm.org/doi/pdf/10.1056/NEJMoa061884
Thus, the reason I don’t think it’s normal for MOS to still be accruing in the P+C Ctl-Arm is that MOS for that regimen historically is in the 10-11 mo. range. BUT, we’re now at about the 14-15 months point for MOS in our Front-Line trial – see below…
Given that our 1st-Line NSCLC trial completed enrollment 9-8-11 (which puts us now at a minimum in the 14-15 mos range from median enrollment date) and that historical MOS for P+C/Alone is in the 10-11 mos. range, I believe Ctl-Arm MOS has been reached (despite their abnormally high ORR & PFS numbers reported 3-9-12), and both Bavi arms are still accruing MOS. If the Bavi arms hold until Nov/Dec, we’re really looking at a heckava MOS advantage for Bavi 1st-Line, just like we saw in 2nd-Line on Sept7.
