AI
Tuesday, February 28, 2012 2:15:38 PM
Thurly+FTM, SK said on 2-14-2012 (BIO-CEO) that for the ongoing randomized 2ndLine-NSCLC trial (n=120), the 1H’12 unblinding could result in an ORR-Only release or “potentially” a ORR and PFS release (followed “probably” by MOS later in the year) – so, we’ll have to play it by ear.
On the randomized Frontline-NSCLC side (n=86), he said to expect Topline ORR in 1H’12, PFS “probably” in 1H’12 (same or diff. time from ORR update?), and “probably” MOS in 2H’12. ==> Update: I just noticed on the Frontline Slide14, it shows both PFS & MOS est. for 2H'12. So, obviously, it just depends on how long it takes the PFS data to mature.
Lest I have misinterpreted his comments, here they are in full re: randomized NSCLC data…
= = = = = = = = =
Feb. 14, 2012: Excerpts+Slides from S.King’s BIO-CEO Talk (NYC)
http://tinyurl.com/86wque8
SKing: “Our lead clinical study is in 2nd-Line NSCLC [Bavi+Doce vs. Doce, n=120], again our strategy of going into high unmet medical need – this is a randomized, double-blinded, placebo-ctl’d study; we worked with the FDA to design this to be part of a registration package, and what we mean by that is we believe this study, with positive results, would be one of the 2 confirmatory studies needed for potential product approval… We completed this study’s enrollment in Oct.2011 and expect to un-blind the data in 1H/2012 (topline tumor response & potentially PFS)… in this patient pop. the median PFS for chemo-alone is expected to be around 4mos. or less. So, a couple of nice data points coming in 1H and then probably a readout of MOS later in the year.”
SK: “In our Front-line randomized, open-label NSCLC trial [Bavi+PC vs. PC, n=86], we completed enrollment in Sept.2011. In Dec.2011 we had an interim data look, actually on the entire Intent-to-Treat patient population, but the early data readout we think was very promising, in which we saw about a 50% increase in tumor resp. rates in the Bavi+chemo arm vs. the chemo-alone arm. What we’re looking to this year is top-line tumor resp. [ORR] data, we still have a few patients that are on study at this time, so in theory these #’s should only improve. The #’s we based on local site reads, so in the top-line data will have the central-reviewed data as well. Additionally, we expect PFS, historically it’s about 4mos. or so, so we expect to see that probably in 1H’12 with MOS coming in 2H’12…”
“…I think importantly, this type of data is exactly what potential partners have been looking for. Tremendous interest – this is an unpartnered program – this is the kind of data that validates the technology, validates the novel target and the mechanism, and it’s exactly what potential partners have wanted to see. And, our goal this year is to parley positive data from these studies into partnerships which would allow us then to continue to advance the program into Phase III in 2013.”
.
.
.
.
On the randomized Frontline-NSCLC side (n=86), he said to expect Topline ORR in 1H’12, PFS “probably” in 1H’12 (same or diff. time from ORR update?), and “probably” MOS in 2H’12. ==> Update: I just noticed on the Frontline Slide14, it shows both PFS & MOS est. for 2H'12. So, obviously, it just depends on how long it takes the PFS data to mature.
Lest I have misinterpreted his comments, here they are in full re: randomized NSCLC data…
= = = = = = = = =
Feb. 14, 2012: Excerpts+Slides from S.King’s BIO-CEO Talk (NYC)
http://tinyurl.com/86wque8
SKing: “Our lead clinical study is in 2nd-Line NSCLC [Bavi+Doce vs. Doce, n=120], again our strategy of going into high unmet medical need – this is a randomized, double-blinded, placebo-ctl’d study; we worked with the FDA to design this to be part of a registration package, and what we mean by that is we believe this study, with positive results, would be one of the 2 confirmatory studies needed for potential product approval… We completed this study’s enrollment in Oct.2011 and expect to un-blind the data in 1H/2012 (topline tumor response & potentially PFS)… in this patient pop. the median PFS for chemo-alone is expected to be around 4mos. or less. So, a couple of nice data points coming in 1H and then probably a readout of MOS later in the year.”
SK: “In our Front-line randomized, open-label NSCLC trial [Bavi+PC vs. PC, n=86], we completed enrollment in Sept.2011. In Dec.2011 we had an interim data look, actually on the entire Intent-to-Treat patient population, but the early data readout we think was very promising, in which we saw about a 50% increase in tumor resp. rates in the Bavi+chemo arm vs. the chemo-alone arm. What we’re looking to this year is top-line tumor resp. [ORR] data, we still have a few patients that are on study at this time, so in theory these #’s should only improve. The #’s we based on local site reads, so in the top-line data will have the central-reviewed data as well. Additionally, we expect PFS, historically it’s about 4mos. or so, so we expect to see that probably in 1H’12 with MOS coming in 2H’12…”
“…I think importantly, this type of data is exactly what potential partners have been looking for. Tremendous interest – this is an unpartnered program – this is the kind of data that validates the technology, validates the novel target and the mechanism, and it’s exactly what potential partners have wanted to see. And, our goal this year is to parley positive data from these studies into partnerships which would allow us then to continue to advance the program into Phase III in 2013.”
.
.
.
.
