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Re: AlpineBV_Miller post# 87211

Wednesday, 12/09/2009 4:22:58 PM

Wednesday, December 09, 2009 4:22:58 PM

Post# of 252300
Re: "That's not correct. Patients all had to be HER2+ to be on the trial"

Yes/No/Maybe?

From the earlier trial:

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Among the findings presented were:

* 25 percent of patients had a confirmed objective response as assessed by an independent review facility (IRF), the primary endpoint of the study. Among these 28 patients, 22 were still receiving T-DM1 at the time of data cut-off for presentation;
* 35 percent of patients had clinical benefit by IRF that consisted of either a confirmed objective response or stable disease lasting for at least 6 months; and
* The anti-tumor activity seen in patients who had received lapatinib as well as trastuzumab was similar to that seen in the overall study population.

Among the 75 efficacy-evaluable patients who were verified to be HER2-positive by a central laboratory:

* 32 percent had a confirmed objective response by IRF; and
* 44 percent had clinical benefit by IRF consisting of either a confirmed objective response or stable disease lasting for at least 6 months.

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OK, I agree that HER2+ was an enrollment condition, but if the central lab disagreed, are they are aren't they?

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