Comments on: Immunogen - What really happened with T-DM1’s filing? http://www.hammerstockblog.com/immunogen-what-really-happened-with-t-dm1%e2%80%99s-filing/ Biotech stock reviews Sat, 19 May 2012 10:29:44 +0000 http://wordpress.org/?v=2.3.1 By: Ohad Hammer http://www.hammerstockblog.com/immunogen-what-really-happened-with-t-dm1%e2%80%99s-filing/#comment-1671 Ohad Hammer Wed, 01 Sep 2010 04:30:21 +0000 http://www.hammerstockblog.com/immunogen-what-really-happened-with-t-dm1%e2%80%99s-filing/#comment-1671 Yes,i am pretty sure as it was specified in the data presentation as well as the actual poster at SABCS2009 (not ASH). Ohad Yes,i am pretty sure as it was specified in the data presentation as well as the actual poster at SABCS2009 (not ASH).

Ohad

]]> By: JQ http://www.hammerstockblog.com/immunogen-what-really-happened-with-t-dm1%e2%80%99s-filing/#comment-1667 JQ Tue, 31 Aug 2010 20:42:10 +0000 http://www.hammerstockblog.com/immunogen-what-really-happened-with-t-dm1%e2%80%99s-filing/#comment-1667 Ohad, Are you sure patients in this study failed Tykerb? I looked at inclusion criteria at clinicaltrials.gov, and ASH 2009 data presentation after this RTF. I started to question if patients failed Tykerb. Inclusion criteria: •Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine. ASH 2009: Prior trastuzumab Median duration of prior trastuzumab in metastatic setting, months (range) 19.4 (2–116) Prior lapatinib Median duration of prior lapatinib in metastatic setting, months (range) 6.9 (0–23) This leads me to think many patients might not have failed Tykerb before enrilling the trial. Ohad,

Are you sure patients in this study failed Tykerb? I looked at inclusion criteria at clinicaltrials.gov, and ASH 2009 data presentation after this RTF. I started to question if patients failed Tykerb.

Inclusion criteria: •Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine.

ASH 2009: Prior trastuzumab
Median duration of prior trastuzumab in metastatic setting,
months (range) 19.4 (2–116)
Prior lapatinib
Median duration of prior lapatinib in metastatic setting, months (range) 6.9 (0–23)

This leads me to think many patients might not have failed Tykerb before enrilling the trial.

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