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AstraZeneca, Daiichi Sankyo: Phase II DESTINY-Breast01 Trial Met Primary Goal

British drug major AstraZeneca Plc (AZN.L,AZN) and Daiichi Sankyo Co. Ltd. (DSKYF.PK) on Wednesday announced that the pivotal Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201) met primary endpoint.

DESTINY-Breast01 is a pivotal Phase II, open-label, global, multicentre, two-part trial of trastuzumab deruxtecan. The HER2-targeting antibody drug conjugate or ADC and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.

The companies expect the positive top-line results to support planned global regulatory submissions, including a Biologics License Application with the US Food and Drug Administration or FDA, anticipated in the second half of 2019.

Trastuzumab deruxtecan has been granted US FDA Breakthrough Therapy Designation and Fast Track Designation for HER2-positive patients in the advanced or refractory breast cancer setting.

José Baselga, Executive Vice President, R&D Oncology, said, "We are encouraged to see positive data from trastuzumab deruxtecan, with the DESTINY-Breast01 trial now reinforcing what earlier data have shown. …. we are eager to bring it as quickly as possible to patients with refractory HER2-positive breast cancer who continue to have high unmet medical need."

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