AstraZeneca, Daiichi Sankyo's Enhertu tops Kadcyla in breast cancer study

AstraZeneca and Daiichi Sankyo reported Monday that Enhertu (trastuzumab deruxtecan) demonstrated superiority versus Roche's Kadcyla (trastuzumab emtansine) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The companies noted that plans for global regulatory submissions in this indication are under way.

The Phase III DESTINY-Breast03 study randomised around 500 patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane to receive either Enhertu or Kadcyla. The trial's primary endpoint is progression-free survival (PFS), while secondary goals include overall survival (OS), objective response rate, duration of response and clinical benefit rate.

PFS goal hit, positive trend for OS

AstraZeneca and Daiichi Sankyo noted that at a planned interim analysis, the independent data monitoring committee (IDMC) concluded that the study met its primary endpoint, showing a highly significant and clinically meaningful improvement in PFS. The companies added that Enhertu also showed a "strong trend" toward improved OS, although these data are still immature. The results are expected to be presented at an upcoming medical meeting.

Ken Takeshita, Daiichi Sankyo's global head of R&D, remarked that the study "is the first global Phase III head-to-head trial of Enhertu against an active control and supports the potential of this medicine to become the new standard of care for patients with HER2-positive metastatic breast cancer following treatment with trastuzumab and a taxane."

Enhertu is currently approved in Canada, Europe, Israel, Japan, the UK and the US for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The HER2-directed antibody-drug conjugate is also approved in Israel, Japan and the US for the treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

 

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