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news.Roche has released positive topline results from its randomised, multicentre international, two-arm, open-label Phase II trial evaluating Trastuzumab emtansine (T-DM1), an antibody-drug conjugate (ADC), in HER2-positive metastatic breast cancer.
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The result of the trial suggested that the patients receiving T-DM1 lived longer with their disease under control (PFS) and experienced fewer side effects typical of chemotherapy.
Roche said the trial was designed to compare T-DM1 single agent to the combination of Herceptin (trastuzumab) and chemotherapy (docetaxel) in previously untreated patients.
The trial recruited 137 patients with first-line HER2-positive metastatic breast cancer from approximately 64 sites, who were randomized to receive either trastuzumab emtansine or Herceptin and chemotherapy.
The primary endpoints of the study were progression-free survival (PFS) and safety, while secondary endpoints were objective response, duration of objective response, and clinical benefit rate.