AstraZeneca: Brilinta, Enhertu Met Primary Endpoint In Respective Trials

AstraZeneca (AZN,AZN.L) announced Monday that its Brilinta (ticagrelor) met primary endpoint in Phase III THALES trial in stroke.

Separately, AstraZeneca announced that the company's and Daiichi Sankyo Co., Ltd.'s Enhertu (trastuzumab deruxtecan) versus chemotherapy met primary endpoint in Phase II DESTINY-Gastric01 trial.

In a statement, AstraZeneca noted that Brilinta 90mg used twice daily and taken with aspirin for 30 days, reached a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.

The THALES trial was conducted in over 11,000 patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack or TIA in the 24 hours prior to treatment initiation.

The preliminary safety findings in the THALES trial were consistent with the known profile of Brilinta, with an increased bleeding rate in the treatment arm.

The company will present the full THALES trial results at a forthcoming medical meeting.

Brilinta is approved in more than 110 countries for the treatment of acute coronary syndrome or ACS and in more than 70 countries for the secondary prevention of cardiovascular or CV events.

Regarding Enhertu, AstraZeneca said the trial met primary endpoint of objective response rate or ORR and key secondary endpoint of overall survival or OS in patients with previously treated HER2-positive metastatic gastric cancer.

The company noted that Enhertu achieved a statistically significant and clinically meaningful improvement in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens including trastuzumab and chemotherapy.

These results confirm activity seen in the non-randomised Phase I trial of Enhertu in patients with HER2-positive advanced gastric cancer published in The Lancet Oncology.

Data from DESTINY-Gastric01 will be presented at a forthcoming medical meeting.

Enhertu is being jointly developed and commercialised worldwide with AstraZeneca except in Japan where Daiichi Sankyo maintains exclusive rights.

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