ExWanna, hold on until Sept. 7th, when Dr. David Gerber speaks about the statistics behind the previously-announced ORR=17.9% (Bavi/3mg) and the doubling(+?) of MOS in the ongoing 2nd-Line NSCLC trial. Then come back and comment on success/failure of each endpoint. Appreciate it.
Sept7: Chicago Symposium in Thoracic Oncology (ASCO/ASTRO) http://tinyurl.com/9vt2vbo …Sept7 1:40-1:50pmCT Dr. David Gerber (UTSW), Late-breaker PLENARY talk on Bavi+Doce 2nd-Line NSCLC Trial …Sept6 5:00-6:30pmCT Dr. K.H. Dragnev (Dartmouth-Hitchcock MC), POSTER on Bavi+PC 1st-Line NSCLC Trial …Sept6 8:00-12:00pmCT Dr. J.Grilley-Olson (UNC), PUB-ONLY on Ist#3, Bavi+Pemcarbo/1st-Line NSCLC Trial …Sept6 6:10-6:25pmCT Dr. David Gerber, Poster Discussion on Tumor-Diameters vs. OS in NSCLC
HINTS OF WHAT's COMING SEPT 7th in Chicago (from S.King, 8-15-12 Wedbush/NYC http://tinyurl.com/8mhrtld ) "With this (2nd-Line NSCLC) data in hand, we now have a number of events to look forward to… We have 2 Late-Breaking presentations coming up… Our goal in the Sept. 7th Chicago data presentation ( http://tinyurl.com/9vt2vbo ) is to be able to talk a little bit more about the (2nd-Line NSCLC) MOS and where we're at evaluating that in both Bavi arms. Even though we haven't reached MOS, and certainly may not have reached it by then, we still will be able to talk a little bit more about where we're at in that process. we'll also be able to talk more about how the statistics in the trial are trending, and how we put those kinds of events together into our thinking about a Phase III trial design. Our goal is to get the data out there, but we're already beginning our EOP2 meeting preparations. We're working actively on a Ph.3 trial design; our goal is to have the EOP2 meeting before the end of the year, which will put us on track for initiating a Ph.3 trial by the middle of 2013. . ."we have a number of key value-drivers coming up. The 2nd-Line NSCLC study is obviously continuing to be the focus, as we have what we believe to be a clear pathway to move that program forward. MOS data, again this is a time-to event and we haven't reached it yet, but at some point in all likelihood we will. We have the upcoming oral presentation at the ASCO Chicago Symposium (9-7-12), as well as at ESMO (9-29-12/Vienna), which gives us a great opportunity to talk about the clinical data and to describe to people why we're so excited about the potential of this trial, and why, not just ourselves, but key opinion leaders that are active in the pgm, as well as potential partners, believe this is a clear path into Phase III and to move the pgm forward.. . The data cut at the end of April already showed that we had clearly reached MOS in the ctl-arm. As we sit here now today, several months later, we still haven't reached that min. # of events for either of the Bavi arms to be there (MOS). It's not quite as simple as a 1-to-1, ie, 1 month doesn't mean it's 1 month addl. in OS, but what we can say is, it [2nd-Line NSCLC MOS] is going to be a very positive result, it's just a matter now of magnitude. Importantly, because we often get this question, potential partners do not need to reach MOS to make a decision on partnering. We do not need to reach MOS in the Bavi arms at this point to plan what the pivotal trial will potentially look like. At this point, we have data, and I think we'll be able to make it clearer when we present the full package on Sept. 7th in Chicago. Basically, the longer, the better, obviously - it's not just great for the program, it's great for the patients, because, again, we do have patients that are out and still even on treatments as we speak."
I really don't understand what your trying to get at here. IMO, this looks like very good results for a phase 2 trial. The company must feel the same way as they already started designing their phase 3 trial. Help me out. Are you saying that they should do the opposite and kill bavi based on the phase 2 results? Maybe your saying that the FDA isn't going to approve a phase 3 trial because of the phase 2 results? Please be more specific.
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