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AstraZeneca, Daiichi Will Seek Approval Following ADC Trial Success In Advanced Breast Cancer

 
• By Sten Stovall

AstraZeneca and Daiichi said their pivotal Phase II DESTINY-Breast01 trial assessing the HER2-targeting antibody drug conjugate trastuzumab deruxtecan met its primary endpoint, supporting global regulatory submission plans starting in this year’s second half.

Dividing breast cancer cell
Trastuzumab deruxtecan showed a clinically-meaningful response rate in patients with refractory HER2-positive metastatic breast cancer. • Source: Shutterstock

Positive Phase II data using trastuzumab deruxtecan to treat advanced HER2-positive breast cancer will now be used by AstraZeneca PLC and Daiichi Sankyo Co. Ltd. to back regulatory submissions around the world, and give further credence to their alliance to jointly commercialize the novel antibody-drug conjugate.

The duo said on 8 May that their pivotal DESTINY-Breast01 trial had met its primary endpoint by demonstrating "a clinically meaningful" response rate in patients with refractory HER2-positive metastatic breast...

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