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news.Study presented at the 32nd Annual San Antonio Breast Cancer Symposium
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ImmunoGen has presented positive clinical data on trastuzumab-DM1 (T-DM1), at the 32nd Annual San Antonio Breast Cancer Symposium. T-DM1 comprises ImmunoGen’s DM1 cancer-cell killing agent linked to the HER2-targeting antibody, trastuzumab, developed by Genentech, a wholly-owned member of the Roche Group.
Reportedly, T-DM1 is in global development by Roche under a collaboration agreement with ImmunoGen. Among the findings reported were that one in three study patients had an objective response to treatment with T-DM1.
In the studies, the patients previously had received, on average, seven different drugs for their advanced breast cancer. In a release issued by Genentech in conjunction with the presentation of the data, Genentech noted the need for new treatment options for advanced HER2-expressing breast cancer and its intention of discussing the next steps for T-DM1 with the FDA.
The study results showed that the T-DM1 objective response rate (ORR) was 32.7%, as assessed by an independent review facility (IRF). ORR is the proportion of study patients who had a durable complete or partial response to treatment with T-DM1, and was the primary endpoint of the study.
In addition, the clinical benefit rate (CBR) was 44.5%. CBR includes patients who had stable disease for six months or longer as well as patients who had an objective response to T-DM1. Among patients who had centrally-confirmed HER2-positive cancer, the ORR was 39.5% and the CBR was 52.6%, as assessed by an IRF, said the company.
Furthermore, among the patients who had qualified for the trial as HER2-positive by local assessment, but were HER2-normal by central assessment, the ORR was 20% and the CBR was 26.7%.
Daniel Junius, president and CEO of ImmunoGen, said: “We’re thrilled with the clinical data reported. It’s deeply gratifying to see so many patients respond to T-DM1, particularly when one considers that their cancer previously had been treated with the two approved HER2-targeting agents as well as with multiple chemotherapies.”