A Phase II study has shown that trastuzumab-DM1 (T-DM1) shrank tumours in one-third of women who had already taken seven medicines on average for advanced HER2-positive breast cancer.
The primary endpoint of the trial, which evaluated single-agent T-DM1 in 110 women, was a complete or partial tumour shrinkage of at least 30%, seen in two tumour assessments at least 28 days apart.
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T-DM1 is an antibody-drug conjugate, which attaches trastuzumab and DM1 together using a stable linker that is capable of destroying cancer cells.
Low levels of platelets in the blood (7%), fatigue (5%) and cellulitis (4%) were the most common severe adverse events of using T-DM1, the study observed.
Swiss drugmaker Roche has licensed the technology for T-DM1 under an agreement with ImmunoGen and submitted a Biologics License Application for the drug to the US Food and Drug Administration.
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