10:26 AM EDT, 04/29/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Monday phase 3 trial data showed Enhertu led to a "statistically significant and clinically meaningful improvement" in progression-free survival compared with chemotherapy in the primary study population of people with HR-positive, HER2-low metastatic breast cancer.

While overall survival results weren't mature at the analysis time, Enhertu also demonstrated an "early trend" toward an overall survival improvement compared with chemotherapy, AstraZeneca ( AZN ) said. The study is proceeding to assess overall survival and additional secondary endpoints, it said. Enhertu, discovered by Daiichi Sankyo, is being developed and commercialized by AstraZeneca ( AZN ) and Daiichi Sankyo, AstraZeneca ( AZN ) said.

Separately, the company said the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending EU approval of a combination of AstraZeneca's ( AZN ) Truqap plus Faslodex to treat breast cancer.

The committee is recommending approval of the combination to treat people with ER-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations, the company said. The recommendation is based on data from a phase 3 trial showing Truqap plus Faslodex "reduced the risk of disease progression or death by 50% versus Faslodex alone in patients with tumours harbouring PI3K, AKT or PTEN alterations," the company said.

AstraZeneca ( AZN ) shares were rising 1.1% in recent Monday trading.

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