First results from a clinical trial of the drug trastuzumab emtansine (T-DM1) made by Genentech, a division of the global pharmaceutical company Roche, show the drug extended the lives of metastatic breast cancer patients without the disease getting worse. The study enrolled people with HER2-positive metastatic breast cancer who had previously received treatment with the drug Herceptin (trastuzumab) and a taxane chemotherapy.
Genentech, in South San Francisco, California, says T-DM1 is an antibody drug conjugate containing the antibody trastuzumab and the chemotherapy DM1, designed to target and inhibit HER2 signaling and deliver the chemotherapy directly inside HER2-positive cancer cells. DM1 was developed by ImmunoGen Inc. in Waltham, Massachusetts, a partner with Genentech in this project.
The study is a randomized, open-label phase 3 clinical trial testing T-DM1 against a control therapy of the drugs lapatinib (Tykerb) plus capecitabine (Xeloda). The first topline results, says Genentech, show people who received T-DM1 lived significantly longer without their disease getting worse — known as progression-free survival — compared to those who received lapatinib plus capecitabine.
The trial, code named EMILIA, aims to enroll 580 patients at 200 sites worldwide. The main outcome measures cover both the drug’s safety and efficacy. Safety indicators include incidence, nature, and severity of adverse events. Efficacy measures are overall survival rates and progression-free survival.
Genentech says the initial safety profile of T-DM1 was consistent with results seen in earlier studies, but it was too early to report results for overall survival rates. Based on the early findings, Genentech plans to submit a Biologics License Application for T-DM1 to the FDA this year to treat HER2-positive metastatic breast cancer. Roche, Genentech’s parent company based in Switzerland, plans to submit a Marketing Authorization Application to the European Medicines Agency this year for the same condition.
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