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ENHERTU Significantly Improved Progression-Free Survival In DESTINY-Breast03 Head-To-Head Trial Versus Trastuzumab Emtansine (T-DM1) In Patients With HER2 Positive Metastatic Breast Cancer

IDMC recommended unblinding based on primary efficacy endpoint demonstrating superiority; results also indicate strong trend toward improved overall survival
Plans for global regulatory submissions underway

Positive topline results from the head-to-head DESTINY-Breast03 phase 3 trial showed that ENHERTU(trastuzumab deruxtecan), the Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca HER2 directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

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At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival (PFS), showing a highly statistically significant and clinically meaningful improvement in PFS for patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

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Breast cancer remains the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five cases of breast cancer are considered HER2 positive.2 Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.3 More effective options are needed to further delay progression and extend survival.3,4,5

In DESTINY-Breast03, ENHERTU also showed a strong trend toward improved overall survival (OS) compared to T-DM1 in a key secondary endpoint, although the OS data are still immature. The safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified and no grade 4 or 5 treatment-related interstitial lung disease events.

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“DESTINY-Breast03 is the first global phase 3 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,” said Ken Takeshita, MD, Global Head, Research and Development, Daiichi Sankyo. “We believe this specifically engineered ADC, with a highly sophisticated delivery system, is fulfilling its promise to reshape the treatment of HER2 positive metastatic breast cancer with the goal to move into earlier lines of treatment for HER2 positive breast cancer, as well as many other HER2 expressing tumor types across our broad clinical trial program.”

“There is a continued need for new options and better outcomes for patients with HER2 positive metastatic breast cancer who often experience disease progression after initial treatment with available standards of care,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “These transformative progression-free survival results demonstrate the superiority of ENHERTU compared to T-DM1 and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings.”

These data will be presented at an upcoming medical meeting and shared with health authorities.

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