By Chris Wack

 

AstraZeneca and Daiichi Sankyo Co. said they said the saw positive results from a Phase II trial that showed Enhertu provided a clinically meaningful and durable tumor response in patients with HER2-positive metastatic and/or unresectable gastric or gastroesophageal junction adenocarcinoma previously treated with a trastuzumab-containing regimen.

Enhertu fam-trastuzumab deruxtecan-nxki is an HER2-directed antibody drug conjugate intended to treat gastric cancer.

In the primary analysis, the first trial of Enhertu specifically in Western patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu demonstrated a confirmed overall response rate of 38% as assessed by independent central review.

Three complete responses and 27 partial responses were observed in patients treated with Enhertu. These results were consistent with those from a previous registrational Phase II trial.

After a median follow-up of 5.7 months, the median duration of response of Enhertu was 8.1 months. The median progression-free survival was 5.5 months. An exploratory endpoint of confirmed disease control rate of 81% was seen.

Enhertu is approved in Israel, Japan and the U.S. for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the trial.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

September 17, 2021 12:50 ET (16:50 GMT)

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