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AstraZeneca, Daiichi Sankyo: ENHERTU Demonstrated Durable Responses In Phase II Trial

AstraZeneca plc (AZN.L,AZN) and Daiichi Sankyo Co. Limited (DSKYF.PK) said Thursday that updated results from the positive DESTINY-Breast01 Phase II trial showed ENHERTU (fam-trastuzumab deruxtecan-nxki) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens.

With a median duration of follow-up of 20.5 months, patients treated with ENHERTU achieved an objective response rate or ORR of 61.4 percent and a median duration of response or DoR of 20.8 months. The median progression-free survival or PFS was 19.4 months.

The updated data were presented in a Spotlight Poster Discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS).

In the previous analysis at 11.1 months of follow-up, an ORR of 60.9 percent was seen with a median DoR of 14.8 months and median PFS of 16.4 months.

AstraZeneca and Daiichi Sankyo said that additional trials are ongoing to confirm the results seen in DESTINY-Breast01.

ENHERTU was approved in the U.S. and Japan for the treatment of HER2-positive, unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens in the metastatic setting based on the earlier results from the DESTINY-Breast01 trial.

In the U.S., ENHERTU was approved under FDA Accelerated Approval and confirmatory trials are underway.

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