joy et all.. conclusions from genentech about tras-dm1 weekly dosed trial
T-DM1 administered on a weekly schedule to patients with HER2-positive metastatic breast
cancer has demonstrated activity and safety results consistent with those observed on an
every-3-week schedule, further supporting the rationale for further studies with this agent.
The MTD of weekly T-DM1 administered intravenously is 2.4 mg/kg.
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At steady state, exposure to T-DM1 is expected to be ~2-fold higher for the weekly regimen
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than for the every-3-week regimen.
The only dose-limiting toxicity observed at 2.9 mg/kg was toxicity preventing retreatment on
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Cycle 1, Day 8.
The most common AEs reported on this schedule were fatigue, thrombocytopenia, nausea,
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transaminase elevation, and headache.
No Grade 4 AEs or cardiac-specific toxicity have been observed.
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Confirmed response rate in response-evaluable patients was 53%.
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Treatment is ongoing for 11 of the 19 patients enrolled.
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A Phase II study of T-DM1 3.6 mg/kg every 3 weeks in patients with HER2-positive metastatic
breast cancer who have progressed on HER2-directed therapy has been initiated; preliminary
results are expected later this year.
N/A
PD
N/A
Dose
1.2 mg/kg
1.6 mg/kg
2.0 mg/kg
2.4 mg/kg
2.9 mg/kg
data as of 2-29-2008