AstraZeneca PLC said its cancer drug Enhertu, developed with Daiichi Sankyo, showed a significant improvement over the standard treatment in a late-stage trial for patients with a high-risk form of early breast cancer.
The Phase III study found that Enhertu was better at preventing the cancer from returning in patients who still had residual disease after initial therapy before surgery, compared to the current standard of care, trastuzumab emtansine, the company said Monday.
This is the second positive late-stage trial for Enhertu in the HER2-positive early breast cancer setting.
"This landmark trial is the first to directly compare Enhertu and T-DM1 in early breast cancer, and the results clearly show that Enhertu delivers superior outcomes, indicating that it may be a better option for patients with high-risk HER2-positive disease in the post-neoadjuvant setting," said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca.
The company reported that the drug's safety profile was consistent with previous studies and that no new safety concerns were identified.
AstraZeneca plans to share the data with global regulatory authorities and present the full results at an upcoming medical conference.
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