T-DMI Phase II Trial Results from ASCO

[Joe]

-- 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.

The most common severe (Grade 3 or 4) adverse events were hypokalemia (lowered potassium levels) in 8 percent of patients and thrombocytopenia (lowered platelet levels) in 7 percent of patients. No severe (Grade 3 or 4) cardiac-specific toxicity was observed.

One patient died during the study due to disease progression, unrelated to treatment with T-DM1.

In February 2009, Genentech and Roche initiated the global Phase III EMILIA study evaluating T-DM1 for second-line treatment of advanced HER2-positive breast cancer. Additionally, Genentech recently completed patient enrollment in a Phase II study evaluating T-DM1 for third-line treatment of advanced HER2-positive breast cancer. Genentech has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the US Food and Drug Administration (FDA).

Regards
Joe