ok. time for what could be a really stupid question.
how can they even calculate a valid MOS in a first line trial for a given experimental drug, when folks will move to second line treatment of some kind when 1st line fails?
Bob, thanks for correcting me on 1 Bavi Arm (3mg) in the 1st-line NSCLC trial, not 2. I knew it, but flipped out & reverted to 2nd-line in my analysis of your exchange with Chris. I'll send a separate question in to IR, but I still think reaching ctl-arm MOS did not (will not) warrant a PR, and I still think it's already happened. I certainly could be wrong, that's for sure!
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.
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