AstraZeneca: disappointment with Dato-DXd in breast cancer

(CercleFinance.com) - AstraZeneca announced on Monday that a Phase III clinical trial evaluating an experimental antibody-drug conjugate in breast cancer had failed to achieve statistical significance in terms of overall survival, leading to a fall in its share price on the London Stock Exchange.


These final results come after interim data, published in 2023, had shown that datopotamab deruxtecan (Dato-DXd) was 'statistically significant' and 'clinically relevant' in improving progression-free survival in the treated population.

The study involved patients with hormone receptor-positive (HR+) but HER2-negative or low HER2-positive breast cancer who had previously received endocrine therapy and at least one systemic treatment for the disease.

For Susan Galbraith, AstraZeneca's Head of Oncology R&D, these results prove the clinical value of datopotamab deruxtecan and encourage further development of the drug.

Developed with Japan's Daiichi Sankyo, datopotamab deruxtecan is currently being tested in some 20 clinical trials in several types of breast cancer.

This announcement overshadows Friday's FDA approval of the pharmaceutical company's first self-administered flu vaccine, a needle-free nasal spray called 'FluMist'.

AstraZeneca also announced that the CHMP of the European Medicines Agency (EMA) had recommended marketing Fasenra for relapsing or refractory eosinophilic granulomatosis with polyangiitis (GEPA), a rare vessel disease that can cause organ damage.

The company's shares were down 0.9% on Monday morning on the London Stock Exchange, one of the biggest decliners on the FTSE index, which was up 0.3%.

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